To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.
- Conditions
- SARS-CoV-2 InfectionCOVID-19
- Interventions
- Biological: BNT162b2Other: PlaceboBiological: BNT162b2 OMIBiological: Combination BNT162b2 and BNT162b2 OMIBiological: Combination (Bivalent) BNT162b2 and BNT162b2 OMI
- Registration Number
- NCT04955626
- Lead Sponsor
- BioNTech SE
- Brief Summary
Substudy A: The study will evaluate the safety, tolerability, and efficacy of a booster dose of BNT162b2 when administered to participants having previously received 2 doses of BNT162b2 at least 6 months prior to randomization.
The study is designed to describe vaccine efficacy of a booster dose of BNT162b2 over time against COVID-19
* At a dose of 30µg (as studied in the Phase 2/3 study C4591001)
* In healthy adults 16 years of age and older
* The duration of the study for each participant will be up to approximately 12 months.
* The study will be conducted in the United States, Brazil and South Africa
Substudy B: The study will assess the safety and tolerability of a single dose of BNT162b2 as compared to placebo control, through the potential analysis of serum troponin levels, in participants ≥12 and ≤30 years of age who have received 2 or 3 prior doses of BNT162b2 (30-µg doses) with their last dose at least 4 months (120 days) prior to randomization.
* Blood samples will be collected for troponin testing
* The duration of the study for each participant will be up to approximately 2 months.
* The study will be conducted in the United States, Germany, Poland and South Africa
Substudy C: The study will assess the safety, tolerability, and immunogenicity of a booster (third) dose of BNT162b2 at doses of 10 µg or 30 µg in participants who have completed a 2-dose primary series of BNT162b2 (30 µg doses) at least 5 months (150 days) prior to randomization.
* In healthy adults 12 years of age and older
* The duration of the study for each participant will be up to approximately 12 months.
* The study will be conducted in the United States, Germany and South Africa
Substudy D: The study will assess the safety, tolerability, and immunogenicity of a 2-dose primary series of BNT162b2 OMI, and as a booster (third, fourth or fifth) dose
* Participants in Cohort 1 will have completed a 2-dose primary series of BNT162b2 (30-µg doses), with their last dose 90 to 240 days prior to enrolment
* Participants in Cohort 2 will be enrolled from Study C4591001 and C4591031 Substudy A and will have completed a 2-dose primary series and received a single booster (third) dose of BNT162b2, with their last dose 90 to 180 days prior to randomization
* Participants in Cohort 3 who are COVID-19 vaccine-naïve and have not experienced COVID-19 will be enrolled to receive 2 doses (primary series) of BNT162b2 OMI, 3 weeks apart, with a dose of BNT162b2 approximately 5 months (150 days) later. If participants do not consent to receive BNT162b2 as a third dose, they will not receive a third dose. No participants should receive BNT162b2 OMI as a third dose.
* In healthy adults 18 to 55 years of age
* The duration of the study for each participant will be up to approximately 12 months.
* The study will be conducted in the United States and South Africa
Substudy E: This study will assess the safety, tolerability, and immunogenicity of high-dose BNT162b2 (60 µg), high-dose BNT162b2 OMI (60 µg), and a high-dose combination of BNT162b2 and BNT162b2 OMI at 60 µg (30 µg each), given as a single dose
* In healthy adults 18 years of age and older who have received 3 prior doses of BNT162b2 (30 µg) with the most recent dose being 5 to 12 months (150 to 360 days) prior to randomization
* The duration of the study for each participant will be approximately 6 months.
* The study will be conducted in the United States
Substudy F: This study will assess the safety, tolerability, and immunogenicity of high-dose BNT162b2 (60 µg), high-dose BNT162b2 OMI (60 µg), and a high-dose combination of BNT162b2 and BNT162b2 OMI at 60 µg (30 µg each), given as a single dose.
* In healthy adults 60 years of age and older who have received 3 prior doses of BNT162b2 (30 µg) with the most recent dose being ≥4 months prior to randomization
* The duration of the study for each participant will be approximately 6 months.
* The study will be conducted in Israel
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16385
- Male or female participants ≥16 years of age at Visit 1 (Day 1) who participated in C4591001.
- Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- Capable of giving signed informed consent.
- Participants who have received 2 prior doses of 30 µg BNT162b2 19-42 days apart, with the second dose being at least 175 days before Visit 1 (Day 1).
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.
- Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Women who are pregnant or breastfeeding.
- Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.
- Prior receipt of any COVID-19 vaccine other than BNT162b2.
- Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
- Receipt of medications intended to prevent COVID-19.
- Prior receipt of more than 2 doses of BNT162b2 30 µg.
- Participation in other studies involving study intervention within 28 days prior to study entry, other than C4591001, and/or within 28 days of confirmed receipt of BNT162b2 within the study.
Substudy B
Inclusion Criteria:
- Male or female participants 12 to 30 years of age, inclusive, who have received 2 prior doses of 30 µg BNT162b2 19 to 60 days apart, with the second dose being at least at least 4 months (120 days) before Visit 1 (Day 1)
- Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- Capable of giving signed informed consent.
Exclusion Criteria:
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.
- Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Women who are pregnant or breastfeeding.
- Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.
- Prior receipt of any COVID-19 vaccine other than BNT162b2.
- Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
- Receipt of medications intended to prevent COVID-19.
- Prior receipt of more than 3 doses of BNT162b2 30 µg.
- Participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID-19, which are prohibited throughout study participation.
Substudy C
Inclusion Criteria:
- Male or female participants ≥12 years of age, inclusive, who have received 2 prior doses of 30 µg BNT162b2 19 to 60 days apart, with the second dose being at least 150 days before Visit 301 (Day 1)
- Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- Capable of giving signed informed consent.
Exclusion Criteria:
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.
- Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Women who are pregnant or breastfeeding.
- Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.
- Prior receipt of any COVID-19 vaccine other than BNT162b2.
- Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
- Receipt of medications intended to prevent COVID-19.
- Prior receipt of more than 2 doses of BNT162b2 30 µg.
- Participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID-19, which are prohibited throughout study participation.
Substudy D
Inclusion Criteria:
- Male or female participants 18 to 55 years of age inclusive
- Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- Cohort 2: Participants who provided a serum sample at Visit 3 in Study C4591001, with Visit 3 occurring within the protocol-specified window.
- Capable of giving signed informed consent
- Cohort 1: Participants who have received 2 prior doses of 30 µg BNT162b2, with the second dose being 90 to 240 days before Visit 401 (Day 1) or Cohort 2: Participants who have received 3 prior doses of 30 µg BNT162b2, with the third dose being 90 to 180 days before Visit 401 (Day 1).
Exclusion Criteria:
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.
- Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Women who are pregnant or breastfeeding.
- Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.
- Cohorts 1 and 2: prior receipt of any COVID-19 vaccine other than BNT162b2.
- Cohort 3 only: prior receipt of any COVID-19 vaccine.
- Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
- Receipt of medications intended to prevent COVID 19.
- Participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID-19, which are prohibited throughout study participation.
Substudy E
Inclusion Criteria:
- Groups 1-6: Male or female participants >55 years of age
- Groups 7-9: Male or female participants 18 to 55 years of age
- Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- Capable of giving signed informed consent.
- Participants who have received 3 prior doses of 30 µg BNT162b2, with the third dose being 5 to 12 months (150 to 360 days) before Visit 601 (Day 1).
- Groups 7 to 9 (sentinel participants): Screening troponin levels must be within normal range prior to randomization.
Exclusion Criteria:
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.
- Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Women who are pregnant or breastfeeding.
- Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.
- Prior receipt of any COVID-19 vaccine other than BNT162b2.
- Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
- Receipt of medications intended to prevent COVID-19.
- Participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID-19, which are prohibited throughout study participation.
Substudy F
Inclusion Criteria:
- Male or female participants ≥60 years of age
- Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- Capable of giving signed informed consent.
- Participants who have received 3 prior doses of 30 µg BNT162b2, with the third dose being ≥4 months before Visit 701 (Day 1).
Exclusion Criteria:
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.
- Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Women who are pregnant or breastfeeding.
- Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.
- Prior receipt of any COVID-19 vaccine other than BNT162b2.
- Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
- Receipt of medications intended to prevent COVID-19.
- Participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID-19, which are prohibited throughout study participation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 60 µg dose BNT162b2 1 dose 10 µg dose BNT162b2 1 dose Placebo Placebo 1 dose 30 µg dose BNT162b2 1 dose 30 µg dose BNT162b2 OMI 1 dose 30 µg dose Combination BNT162b2 and BNT162b2 OMI 1 dose 60 µg dose BNT162b2 OMI 1 dose 60 µg dose Combination (Bivalent) BNT162b2 and BNT162b2 OMI 1 dose 30 µg dose Combination (Bivalent) BNT162b2 and BNT162b2 OMI 1 dose 60 µg dose Combination BNT162b2 and BNT162b2 OMI 1 dose
- Primary Outcome Measures
Name Time Method SSA - Percentage of participants reporting serious adverse events from the booster dose to 6 months after the booster dose As elicited by investigational site staff
SSB - Percentage of participants with elevated troponin I levels through 1 month after the second vaccination Troponin I level
SSB - Percentage of participants reporting adverse events within 1 month after each vaccination As elicited by investigational site staff
SSB - Percentage of participants reporting serious adverse events within 1 month after each vaccination As elicited by investigational site staff
SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months per 1000 person-years of blinded follow-up
SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months per 1000 person-years of blinded follow-up
SSA - Percentage of participants reporting adverse events from the booster dose to 1 month after the booster dose As elicited by investigational site staff
SSB - Percentage of participants reporting local reactions For 7 days following each vaccination Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
SSB - Percentage of participants reporting systemic events For 7 days following each vaccination Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
SSC - Percentage of participants reporting adverse events from the booster dose to 1 month after the booster dose As elicited by investigational site staff
SSC - Percentage of participants reporting local reactions For 7 days following the booster dose Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
SSC - Percentage of participants reporting systemic events For 7 days following the booster dose Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
SSC - the immune response to BNT162b2 10 µg and 30 µg given as the third dose in participants 12 through 17 years of age and a third dose of BNT162b2 30 µg in a randomly selected subset of participants 18 through 55 years of age from study C4591001 At baseline (before the third dose), 1 month and 6 months after the third dose GMTs at each time point
GMFRs from baseline (before the third dose) to each subsequent time point after the third dose
Percentage of participants with seroresponse at each time point after the third doseSSC - Percentage of participants reporting serious adverse events from the booster dose to 6 months after the booster dose As elicited by investigational site staff
SSD - Percentage of participants reporting systemic events For 7 days following each vaccination Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
SSD - Percentage of participants reporting local reactions For 7 days following each vaccination Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
SSD - Percentage of participants reporting adverse events from the first study vaccination (received in this study) through 1 month after the last study vaccination As elicited by investigational site staff
SSD - Percentage of participants reporting serious adverse events from the first study vaccination (received in this study) through 6 months after the last study vaccination As elicited by investigational site staff
SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose BNT162b2 OMI compared to after 1 dose BNT162b2 given as the D4 in BNT162b2-experienced participants 1 month after receipt of 1 dose of study intervention GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI to those at 1 month after 1 dose of BNT162b2 given as the fourth dose in BNT162b2-experienced participants
The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of BNT162b2 OMI and at 1 month after 1 dose of BNT162b2 given as the fourth dose in BNT162b2-experienced participantsSSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 2 doses BNT162b2 OMI compared to after 2 doses BNT162b2 in participants from the C4591001 study 1 month after receipt of the second dose of BNT162b2 OMI or BNT162b2 as appropriate GMR of the Omicron-neutralizing titers 1 month after the second dose of BNT162b2 OMI to 1 month after the second dose of BNT162b2 in participants selected from the C4591001 study
The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after the second dose of BNT162b2 OMI and at 1 month after the second dose of BNT162b2 in participants selected from the C4591001 studySSE - Percentage of participants reporting local reactions For 7 days following the study vaccination Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
SSE - Percentage of participants reporting systemic events For 7 days following the study vaccination Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
SSE - Percentage of participants reporting serious adverse events from the study vaccination through 6 months after the study vaccination As elicited by investigational site staff
SSF - Percentage of participants reporting serious adverse events from the study vaccination through 6 months after the study vaccination As elicited by investigational site staff
SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as D3 in BNT162b2-experienced participants 1 month after receipt of 1 dose of study intervention GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI to those at 1 month after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants
The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of BNT162b2 OMI and at 1 month after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participantsSSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse of anti-Omi immune response after 2 doses BNT162b2 OMI given as D3+D4 compared to after 1 dose BNT162b2 given as D3 in BNT162b2-experienced participants 1 month after receipt of 1 or 2 doses of intervention as appropriate GMR of the Omicron-neutralizing titers at 1 month after 2 doses of BNT162b2 OMI to those at 1 month after 1 dose of BNT162b2 given as the third (and fourth) dose in BNT162b2-experienced participants
The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 2 doses of BNT162b2 OMI and at 1 month after 1 dose of BNT162b2 given as the third (and fourth) dose in BNT162b2-experienced participantsSSE - Noninferiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age 1 month after receipt of 1 dose of study intervention given as a fourth dose The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of BNT162b2 OMI 30 µg and at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Superiority of neutralizing titer after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age 1 month after receipt of 1 dose of study intervention given as a fourth dose GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI at 60 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Superiority of neutralizing titer after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age 1 month after receipt of 1 dose of study intervention given as a fourth dose GMR of the Omicron-neutralizing titers at 1 month after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Percentage of participants reporting adverse events from the study vaccination through 1 month after the study vaccination As elicited by investigational site staff
SSE - Percentage of participants with elevated troponin I levels (18-55 years of age, sentinel cohort only) Before and 3 days after study vaccination Troponin I level
SSE - Noninferiority of anti-Omicron immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age 1 month after receipt of 1 dose of study intervention given as a fourth dose The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg and at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSF - Percentage of participants reporting local reactions For 7 days following the study vaccination Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
SSF - To describe the immune response to BNT162b2 (30 µg or 60 µg), BNT162b2 OMI (30 µg or 60 µg), and a combination of BNT162b2 and BNT162b2 OMI (30 µg or 60 µg) given as a fourth dose in BNT162b2-experienced participants At each time point GMT of Omicron and reference-strain neutralizing titers
GMFRs of Omicron and reference-strain neutralizing titers from before the study vaccination to subsequent time points
Percentages of participants with seroresponse for Omicron and reference-strain neutralizing titers at each time point
GMRs of Omicron and reference-strain neutralizing titers at each time point after the study vaccination between different vaccine groupsSSE - Superiority of neutralizing titer after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age 1 month after receipt of 1 dose of study intervention given as a fourth dose GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI at 30 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Noninferiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age 1 month after receipt of 1 dose of study intervention given as a fourth dose The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of BNT162b2 OMI 60 µg and at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Noninferiority of anti-Omicron immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age 1 month after receipt of 1 dose of study intervention given as a fourth dose The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg and at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Superiority of neutralizing titer after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age 1 month after receipt of 1 dose of study intervention given as a fourth dose GMR of the Omicron-neutralizing titers at 1 month after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2
SSF - Percentage of participants reporting systemic events For 7 days following the study vaccination Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
SSF - Percentage of participants reporting adverse events from the study vaccination through 1 month after the study vaccination As elicited by investigational site staff
- Secondary Outcome Measures
Name Time Method SSD - The "super" superiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI given as the third and fourth doses compared to after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants 1 month after receipt of 1 or 2 doses of intervention as appropriate GMR of the Omicron-neutralizing titers at 1 month after 2 doses of BNT162b2 OMI to those at 1 month after 1 dose of BNT162b2 given as the third (and fourth) dose in BNT162b2-experienced participants
SSE - Noninferiority of anti-reference strain immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age 1 month after receipt of 1 dose of study intervention given as a fourth dose GMR of the reference strain-neutralizing titers at 1 month after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSE - The "super" superiority of anti-Omicron immune responses after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age 1 month after receipt of 1 dose of study intervention given as a fourth dose GMR of the Omicron-neutralizing titers at 1 month after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSA - Confirmed severe COVID-19 (based on CDC definition) in participants without evidence of past SARS-CoV-2 infection from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months per 1000 person-years of blinded follow-up
SSE - The "super" superiority of anti-Omicron immune responses after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age 1 month after receipt of 1 dose of study intervention given as a fourth dose GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI at 60 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSA - Confirmed severe COVID-19 (based on FDA definition) in participants with and without evidence of past SARS-CoV-2 infection from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months per 1000 person-years of blinded follow-up
SSC - Immune responses to BNT162b2 10 µg and 30 µg given as the third dose in participants 12 through 17 years of age At baseline (before the third dose) and 7 days after the third dose GMTs at each time point
GMFRs from baseline (before the third dose) to 7 days after the third dose
Percentage of participants with seroresponse at 7 days after the third doseSSD - The "super" superiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as the fourth dose in BNT162b2-experienced participants 1 month after receipt of 1 dose of study intervention GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI to those at 1 month after 1 dose of BNT162b2 given as the fourth dose in BNT162b2-experienced participants
SSE - Noninferiority of anti-reference-strain immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age 1 month after receipt of 1 dose of study intervention given as a fourth dose GMR of the reference strain-neutralizing titers at 1 month after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSE - The "super" superiority of anti-Omicron immune responses after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age 1 month after receipt of 1 dose of study intervention given as a fourth dose GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI at 30 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSA - Confirmed severe COVID-19 (based on FDA definition) period in participants without evidence of past SARS-CoV-2 infection from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months per 1000 person-years of blinded follow-up
SSA - Confirmed severe COVID-19 (based on CDC definition) in participants with and without evidence of past SARS-CoV-2 infection from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months per 1000 person-years of blinded follow-up
SSD - The "super" superiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants 1 month after receipt of 1 dose of study intervention GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI to those at 1 month after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants
SSD - The noninferiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in participants selected from the C4591001 study 1 month after receipt of the second dose of BNT162b2 OMI or BNT162b2 as appropriate GMR of the Omicron-neutralizing titers 1 month after the second dose of BNT162b2 OMI to the reference-strain-neutralizing titers 1 month after the second dose of BNT162b2 in participants selected from the C4591001 study
The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after the second dose of BNT162b2 OMI and seroresponsea to the reference strain at 1 month after the second dose of BNT162b2 in participants selected from the C4591001 studySSD - The "super" superiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI compared to after 2 doses of BNT162b2 in participants selected from the C4591001 study 1 month after receipt of the second dose of BNT162b2 OMI or BNT162b2 as appropriate GMR of the Omicron-neutralizing titers 1 month after the second dose of BNT162b2 OMI to 1 month after the second dose of BNT162b2 participants selected from the C4591001 study
SSE - The "super" superiority of anti-Omicron immune responses after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age 1 month after receipt of 1 dose of study intervention given as a fourth dose GMR of the Omicron-neutralizing titers at 1 month after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants
Trial Locations
- Locations (140)
Wenatchee Valley Hospital
🇺🇸Wenatchee, Washington, United States
Tiervlei Trial Centre
🇿🇦Cape Town, Western CAPE, South Africa
Kaiser Permenente Medical Center Infectious Disease
🇺🇸Los Angeles, California, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Obras Sociais Irma Dulce
🇧🇷Salvador, Bahia, Brazil
HOPE Research Institute
🇺🇸Phoenix, Arizona, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Sterling Research Group, Ltd.
🇺🇸Cincinnati, Ohio, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Kaiser Permanente Center for Health Research
🇺🇸Portland, Oregon, United States
Renu Garg, MD Pediatrics
🇺🇸Houston, Texas, United States
Van Tran Family Practice
🇺🇸Houston, Texas, United States
Ventavia Research Group, LLC
🇺🇸Houston, Texas, United States
DM Clinical Research-Bellaire
🇺🇸Houston, Texas, United States
Clinical Trials of Texas, LLC
🇺🇸San Antonio, Texas, United States
North Alabama Research Center
🇺🇸Athens, Alabama, United States
Alliance for Multispecialty Research, LLC
🇺🇸Wichita, Kansas, United States
Accel Research Sites - Birmingham Clinical Research Unit
🇺🇸Birmingham, Alabama, United States
Whiteriver Indian Hospital- Garrett Building
🇺🇸Whiteriver, Arizona, United States
Kaiser Permanente
🇺🇸Los Angeles, California, United States
Whiteriver Indian Hospital
🇺🇸Whiteriver, Arizona, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Collaborative Neuroscience Research, LLC
🇺🇸Long Beach, California, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Velocity Clinical Research, Sioux City
🇺🇸Sioux City, Iowa, United States
IACT Health
🇺🇸Columbus, Georgia, United States
PharmQuest Life Sciences, LLC
🇺🇸Greensboro, North Carolina, United States
MedPharmics, LLC
🇺🇸Gulfport, Mississippi, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
VA Northeast Ohio Healthcare System
🇺🇸Cleveland, Ohio, United States
Dayton Clinical Research
🇺🇸Dayton, Ohio, United States
Lehigh Valley Health Network/Network Office of Research and Innovation
🇺🇸Allentown, Pennsylvania, United States
Accellacare (formerly PMG Research of Wilmington, LLC)
🇺🇸Wilmington, North Carolina, United States
Main Street Physician's Care
🇺🇸Little River, South Carolina, United States
PriMED Clinical Research
🇺🇸Dayton, Ohio, United States
Clinical Neuroscience Solutions Inc.
🇺🇸Memphis, Tennessee, United States
Accellacare - Salisbury
🇺🇸Salisbury, North Carolina, United States
Lynn Institute of Norman
🇺🇸Norman, Oklahoma, United States
M3 Wake Research, Inc.
🇺🇸Raleigh, North Carolina, United States
Senders Pediatrics
🇺🇸South Euclid, Ohio, United States
Velocity Clinical Research, Providence
🇺🇸East Greenwich, Rhode Island, United States
Aventiv Research Inc
🇺🇸Columbus, Ohio, United States
Lillestol Research
🇺🇸Fargo, North Dakota, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Alliance for Multispecialty Research - Weisgarber Medical Park
🇺🇸Knoxville, Tennessee, United States
Trinity Clinical Research
🇺🇸Tullahoma, Tennessee, United States
Benchmark Research
🇺🇸Fort Worth, Texas, United States
DM Clinical Research
🇺🇸Tomball, Texas, United States
HG Pediatrics
🇺🇸Houston, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States
Clinical Alliance for Research & Education - Infectious Diseases (CARE-ID)
🇺🇸Annandale, Virginia, United States
SMS Clinical Research
🇺🇸Mesquite, Texas, United States
Ventavia Research Group
🇺🇸Keller, Texas, United States
SCR of Texas, LLC
🇺🇸Keller, Texas, United States
LinQ Research, LLC
🇺🇸Pearland, Texas, United States
IMA Clinical Research San Antonio
🇺🇸San Antonio, Texas, United States
Dr A Jacovides & Partners Inc.
🇿🇦Midrand, Gauteng, South Africa
IKF Pneumologie GmbH & Co. KG
🇩🇪Frankfurt, Germany
Clinresco Centres
🇿🇦Kempton Park, Gauteng, South Africa
Virginia Research Center
🇺🇸Midlothian, Virginia, United States
Studienzentrum Dr. Keller
🇩🇪Frankfurt, Germany
Sheba Medical Center
🇮🇱Ramat Gan, Hamerkaz, Israel
Botho Ke Bontle Health Services PTY LTD
🇿🇦Pretoria, Gauteng, South Africa
Velocity Clinical Research, Cleveland
🇺🇸Cleveland, Ohio, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Quality Clinical Research
🇺🇸Omaha, Nebraska, United States
Medical Affiliated Research Center
🇺🇸Huntsville, Alabama, United States
Johns Hopkins Center for American Indian Health
🇺🇸Shiprock, New Mexico, United States
The Pain Center of Arizona
🇺🇸Phoenix, Arizona, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Paradigm Clinical Research Centers, Inc
🇺🇸Redding, California, United States
Velocity Clinical Research, Westlake
🇺🇸Los Angeles, California, United States
California Research Foundation
🇺🇸San Diego, California, United States
Velocity Clinical Research, North Hollywood
🇺🇸North Hollywood, California, United States
Kaiser Permanente Oakland
🇺🇸Oakland, California, United States
Kaiser Permanente Santa Clara
🇺🇸Santa Clara, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Lynn Institute of Denver
🇺🇸Aurora, Colorado, United States
Bayview Research Group, LLC
🇺🇸Valley Village, California, United States
Clinical Research Consulting
🇺🇸Milford, Connecticut, United States
Indago Research & Health Center, Inc
🇺🇸Hialeah, Florida, United States
Research Centers of America ( Hollywood )
🇺🇸Hollywood, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
🇺🇸Memphis, Tennessee, United States
Acevedo Clinical Research Associates
🇺🇸Miami, Florida, United States
Meridian Clinical Research, LLC
🇺🇸Cincinnati, Ohio, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Kentucky Pediatric/ Adult Research
🇺🇸Bardstown, Kentucky, United States
Johns Hopkins Bayview Medical Center
🇺🇸Baltimore, Maryland, United States
Louisiana State University Health Sciences Shreveport
🇺🇸Shreveport, Louisiana, United States
University of Massachusetts Chan Medical School
🇺🇸Worcester, Massachusetts, United States
Michigan Center of Medical Research (MICHMER)
🇺🇸Farmington Hills, Michigan, United States
Sundance Clinical Research
🇺🇸Saint Louis, Missouri, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research
🇺🇸Bozeman, Montana, United States
Methodist Physicians Clinic/CCT Research
🇺🇸Fremont, Nebraska, United States
Velocity Clinical Research, Omaha
🇺🇸Omaha, Nebraska, United States
Bozeman Health Deaconess Hospital
🇺🇸Bozeman, Montana, United States
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Meridian Clinical Research
🇺🇸Cincinnati, Ohio, United States
Wake Research - Clinical Research Center of Nevada, LLC
🇺🇸Las Vegas, Nevada, United States
Amici Clinical Research LLC
🇺🇸Raritan, New Jersey, United States
South Jersey Infectious Disease
🇺🇸Somers Point, New Jersey, United States
IMA Clinical Research Warren
🇺🇸Warren, New Jersey, United States
Northern Navajo Medical Center
🇺🇸Shiprock, New Mexico, United States
NYU Langone Health
🇺🇸New York, New York, United States
Gallup Indian Medical Center
🇺🇸Gallup, New Mexico, United States
Meridian Clinical Research LLC
🇺🇸Binghamton, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
University of Rochester Medical Center- Kari Steinmetz
🇺🇸Rochester, New York, United States
Accellacare
🇺🇸Winston-Salem, North Carolina, United States
Rochester General Hospital Infectious Disease
🇺🇸Rochester, New York, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Duke Vaccine and Trials Unit
🇺🇸Durham, North Carolina, United States
Clinical Research Associates Inc
🇺🇸Nashville, Tennessee, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
North Texas Infectious Diseases Consultants, P.A
🇺🇸Dallas, Texas, United States
CEPIC - Centro Paulista de Investigação Clínica
🇧🇷São Paulo, Brazil
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
Benaroya Research Institute at Virginia Mason
🇺🇸Seattle, Washington, United States
Newtown Clinical Research
🇿🇦Johannesburg, Gauteng, South Africa
The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric
🇮🇱Ramat Gan, Hamerkaz, Israel
Jongaie Research
🇿🇦Pretoria, South Africa
Limpopo Clinical Research Initiative
🇿🇦Thabazimbi, Limpopo, South Africa
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Yale-New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Yale Center for Clinical Investigation
🇺🇸New Haven, Connecticut, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
TREAD Research
🇿🇦Cape Town, Western CAPE, South Africa
Synergy Biomed Research Institute
🇿🇦East London, Eastern CAPE, South Africa
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
ARC Clinical Research at Four Points
🇺🇸Austin, Texas, United States
Tekton Research, Inc
🇺🇸Austin, Texas, United States
MIC Medial Imaging Consultants
🇨🇦Edmonton, Alberta, Canada
University of Rochester
🇺🇸Rochester, New York, United States
Worthwhile Clinical Trials
🇿🇦Benoni, Gauteng, South Africa