Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis
- Conditions
- Lyme Borreliosis
- Interventions
- Biological: VLA15Biological: Placebo
- Registration Number
- NCT03970733
- Lead Sponsor
- Pfizer
- Brief Summary
In the Main Study Phase a total of 246 subjects were randomized 2:2:1 into three treatment groups to receive either VLA15 with Alum (lower or higher dose) or Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1, Day 57 and Day 180.
In the Booster Phase subjects from the higher dose group who completed their primary immunization schedule according to protocol will be randomized 2:1 to receive an additional higher dose VLA15 vaccination or Placebo at Month 18.
Study duration in the Main Study Phase per subject is a maximum of 20 months. Overall study Duration is estimated to be 22 months.
Study duration per subject in the Booster Phase is a maximum of approximately 13 months.
Study duration per subject in the Main Study Phase and Booster Phase together is estimated to be a maximum of approximately 33 months.
Overall study duration (i.e., First-Subject-In to Last-Subject Out/ end of Booster Phase) is estimated to be approximately 37 months.
- Detailed Description
This is a randomized, observer-blind (subject, Sponsor and investigator/site staff involved in Clinical Evaluation of subjects are blinded), Placebo controlled, multicenter Phase 2 study.
In Main Study Phase a total of 246 healthy subjects,aged 18 to 65 years, were randomized 2:2:1 to receive either VLA15 with Alum (lower or higher doser Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1 (Month 0), Day 57 (Month 2) and Day 180 (Month 6).
Subjects from the higher dose group who completed their primary immunization schedule according to protocol, will be randomized 2:1 to receive an additional injection of the higher dose VLA15 with Alum or Placebo in a Booster Phase. The additional vaccination is administered as intramuscular injection approximately 18 months after the first immunization.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 246
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VLA15 with Alum higher dose VLA15 Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15 with Alum lower dose VLA15 Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued Placebo Placebo Main Study Phase: placebo - Booster Phase: arm discontinued
- Primary Outcome Measures
Name Time Method GMTs for IgG Against Each OspA Serotype Day 208 (Month 7) Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) against each Outer Surface Protein A (OspA) serotype ST1 to ST6, determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 208 (Month 7)
- Secondary Outcome Measures
Name Time Method GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase Day 1 (baseline from where comparison was done), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18) Geometric Mean Fold Rise (GMFR) as compared to baseline for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18).
Percentage of Participants With Related Unsolicited AEs During the Main Study Phase From Day 1 of vaccination up to Day 545 (Month 18) An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30 SCR for each OspA serotype specific IgG ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24, and Month 30. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): greater than or equal to (\>=) 4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. Percentages are based on the number of participants with non-missing observations. The outcome measure was planned to be analyzed for Booster PP population from Day 29 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population Month 18 (from where comparison was done), Month 19, Month 24 and Month 30 GMFR as compared to Month 18 (pre-booster) for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Month 19, Month 24 and Month 30. The outcome measure was planned to be analyzed for Booster PP population.
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years Day 1 (baseline), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18) GMFR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 18 - 49 years.
Percentage of Participants With Related AESIs During the Main Study Phase From Day 1 of vaccination up to Day 545 (Month 18) AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Percentage of Participants With Unsolicited AEs During the Main Study Phase From Day 1 of vaccination up to Day 545 (Month 18) An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Two-sided 95% confidence intervals were calculated according to Altman method.
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18) GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 50 - 65 years.
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years Day 1 (baseline), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18) GMFR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 50 - 65 years.
Percentage of Participants With Serious Adverse Events (SAEs) During the Main Study Phase From Day 1 of vaccination up to Day 545 (Month 18) SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Two-sided 95% confidence intervals were calculated according to Altman method.
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population Day 1 (baseline from where comparison was done), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30 GMFR as compared to baseline for IgG against each Osp serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 were reported in this outcome measure. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Percentage of Participants With Related SAEs During the Entire Booster Phase From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months) SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Percentage of Participants With Related AESIs During the Entire Booster Phase From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months) AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase SAEs and AESIs: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months); AEs: From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month) Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs during booster phase stratified by age group 18-49 years and 50-65 years were reported. SAE: any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. AESI: any AEs of scientific/medical concern specific to study vaccine; Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AE: any untoward medical occurrence in participant associated with use of study vaccine, whether or not related to study vaccine, reported in addition to solicited and any solicited symptom with onset outside specified period of follow-up.
GMTs for IgG Against Each OspA Serotype During the Main Study Phase At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 365 (Month 12) and Day 545 (Month 18) GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 365 (Month 12) and 545 (Month 18).
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18) Seroconversion Rate (SCR) for each Outer Surface Protein A (OspA) serotype specific IgG ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18). Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): greater than or equal to (\>=) 4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. Percentages are based on the number of participants with non-missing observations.
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18) SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 18 - 49 years. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): \>=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants.
Percentage of Participants Adverse Event of Special Interest (AESIs) During the Main Study Phase From Day 1 of vaccination up to Day 545 (Month 18) AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Two-sided 95% confidence intervals were calculated according to Altman method.
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase From Day 1 of vaccination up to Day 545 (Month 18) Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs during main study phase stratified by age group 18-49 years and 50-65 years were reported. SAE: any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. AESI: any AEs of scientific/medical concern specific to study vaccine. Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AE: any untoward medical occurrence in participant associated with use of study vaccine, whether or not related to study vaccine, reported in addition to solicited and any solicited symptom with onset outside specified period of follow-up. Two-sided 95% confidence intervals were calculated according to Altman method.
Percentage of Participants With Related Unsolicited AEs During the Booster Phase up to Month 19 From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month) An unsolicited AE included any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18) GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 18 - 49 years.
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18) SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 50 - 65 years. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): \>=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants.
Percentage of Participants With Related SAEs During the Main Study Phase From Day 1 of vaccination up to Day 545 (Month 18) SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30 GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 stratified by age group: 18 - 49 years. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30 SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24, and Month 30 stratified by age group: 50 - 65 years. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): \>=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. The outcome measure was planned to be analyzed for Booster PP population from Day 29 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Percentage of Participants With Unsolicited AEs During the Booster Phase up to Month 19 From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month) An unsolicited AE includes any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Two-sided 95% confidence intervals were calculated according to Altman method.
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase Up to 7 days after Vaccination 1, 2 and 3; Up to 7 days after any vaccination Solicited local AEs included pain, tenderness, induration (hardening), swelling and erythema (redness). Solicited systemic AEs included headache, myalgia (muscle pain), arthralgia (joint pain), fever (oral body temperature), flu-like symptoms, nausea, vomiting and fatigue. Two-sided 95% confidence intervals were calculated according to Altman method.
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30 GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24, and Month 30. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population Day 208 (from where comparison was done), Month 19, Month 24 and Month 30 GMFR as compared to Day 208 for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Month 19, Month 24 and Month 30. The outcome measure was planned to be analyzed for Booster PP population from Day 208 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Vaccination Within 7 days after booster vaccination Solicited local AEs included pain, tenderness, induration (hardening), swelling and erythema (redness). Solicited systemic AEs included headache, myalgia (muscle pain), arthralgia (joint pain), fever (oral body temperature), flu-like symptoms, nausea, vomiting and fatigue. Two-sided 95% confidence intervals were calculated according to Altman method.
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30 GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 stratified by age group: 50 - 65 years. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30 SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 stratified by age group: 18 - 49 years was presented in this outcome measure. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): \>=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. The outcome measure was planned to be analyzed for Booster PP population from Day 29 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Percentage of Participants With SAEs During the Entire Booster Phase From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months) SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Two-sided 95% confidence intervals were calculated according to Altman method.
Percentage of Participants With Adverse Event of Special Interest (AESIs) During the Entire Booster Phase From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months) AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Two-sided 95% confidence intervals were calculated according to Altman method.
Trial Locations
- Locations (5)
Clinical Research Consulting, LLC
🇺🇸Milford, Connecticut, United States
Stamford Therapeutics Consortium
🇺🇸Stamford, Connecticut, United States
United Medical Associates
🇺🇸Binghamton, New York, United States
Regional Clinical Research, Inc
🇺🇸Endwell, New York, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States