A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to<18 Years) at Risk for SARS-CoV-2

Phase 3

Completed

Conditions: SARS-CoV Infection
Covid19

Interventions: Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Second Booster Vaccination)
Other: Placebo (Initial Vaccination Period)
Other: Placebo (Crossover Vaccination period)
Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period)

Registration Number: NCT04611802

Lead Sponsor: Novavax

Brief Summary: This is a phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants and adolescent participants. Additionally providing a Booster Dose to fully vaccinated participants. A substudy is to be conducted at selected sites to evaluate the safety and immunogenicity of a fourth dose (second booster) of NVX-CoV2373 in adults and adolescents, previously fully vaccinated and subsequently boosted with a third dose (first booster)

Detailed Description: This is a Phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants ≥ 18 years of age (Adult Main Study) and adolescent participants 12 to \<18 years (Pediatric Expansion). Additionally, a Booster Amendment will allow for the evaluation of a booster dose of SARS-CoV-2 rS with Matrix-M1 adjuvant in participants who completed the primary series of active vaccine in the Adult Main Study or Pediatric Expansion, as well as in participants who previously completed the primary series of an authorized/approved COVID-19 vaccine. Additionally, a sub-study conducted at specific sites will allow for the evaluation of a second booster dose of SARS-CoV-2 rS with Matrix-M1 adjuvant in participants who completed the primary series of active vaccine in the Adult Main Study and Pediatric Expansion as well as a booster dose in the Booster Amendment of the study.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 33000

Inclusion Criteria

Adult Participants :

Each participant in the Adult Main Study and/or the Booster Amendment must meet all of the following criteria to be enrolled in this study:

Adults ≥ 18 years of age at screening who, by virtue of age, race, ethnicity or life circumstances, are considered at substantial risk of exposure to and infection with SARS CoV-2.
Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [i.e., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through 3 months after the last vaccination OR agree to consistently use a medically acceptable method of contraception from at least 28 days prior to enrollment and through 3 months after the last vaccination.
Is medically stable, as determined by the investigator (based on review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). Vital signs must be within medically acceptable ranges prior to the first vaccination.
Agree to not participate in any other SARS-CoV-2 prevention trial during the study follow-up.
For the Booster Amendment only, active participants who received a full dose regimen of active vaccine (SARS-CoV-2 rS with Matrix-M1 adjuvant) or any authorized/approved COVID-19 vaccine are eligible for participation. Such participants must demonstrate receipt by producing valid documentation of vaccination at the booster visit.

Pediatric Participants :

Each participant in the Pediatric Expansion and/or the Booster Amendment must meet all of the following criteria to be enrolled in this study:

Pediatric participants 12 to < 18 years of age at screening, determined to be healthy or medically stable by the investigator (based on review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). Vital signs must be within medically acceptable ranges prior to the first vaccination.
Participant and parent(s)/caregiver(s) or legally acceptable representative willing and able to give informed consent and assent, as required, prior to study enrollment and to comply with study procedures.
Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] must agree to be heterosexually inactive from at least 28 days prior to enrollment and through 3 months after the last vaccination OR agree to consistently use a medically acceptable method of contraception from at least 28 days prior to enrollment and through 3 months after the last vaccination.
Agree to not participate in another SARS-CoV-2 prevention trial during the study follow-up.
For the Booster Amendment only, active participants who received a full dose regimen of active vaccine (SARS-CoV-2 rS with Matrix-M1 adjuvant) or any authorized/approved COVID-19 vaccine are eligible for participation. Such participants must demonstrate receipt by producing valid documentation of vaccination.

Site-Specific Sub Study:

Each participant in the Substudy must meet all of the following criteria to be enrolled in this study:

Be an active, enrolled participant in the 2019nCoV-301 study.
Adults 18 years of age or older or adolescents 12 to < 18 years of age at initial screening for the parent study.
Willing and able to give informed consent prior to substudy enrollment and to comply with extra study procedures.
Documented receipt of the 2 doses of the primary series of NVX-CoV2373 and the booster (third dose) of NVX-CoV2373 in the parent protocol. The booster dose must have been administered at least 6 months prior to entering the substudy.
Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile or postmenopausal) must agree to be heterosexually inactive from at least 28 days prior to entering and through the end of the substudy OR agree to consistently use a medically acceptable method of contraception for the 28 days of follow-up for the substudy.
Is medically stable, as determined by the investigator (based on review of health status, vital signs (to include body temperature) and targeted physical examination (if medically indicated by reported symptoms). Vital signs must be within medically acceptable ranges prior to administration of study vaccination.
Agree to not participate in any other non-NVX-CoV2373 study during the substudy.

Note: For participants who develop COVID-19, anti-SARS-CoV-2 therapy (approved, authorized or investigational) is permitted.

Exclusion Criteria

Adult and adolescent participants meeting any of the following criteria will be excluded from the study:

Unstable acute or chronic illness. Criteria for unstable medical conditions include:
1. Substantive changes in chronic prescribed medication (change in class or significant change in dose) in the past 2 months.
2. Currently undergoing workup of undiagnosed illness that could lead to diagnosis of a new condition.
Note: Well-controlled human immunodeficiency virus [HIV] with undetectable HIV RNA [< 50 copies/mL] and CD4 count > 200 cells/µL for at least 1 year, documented within the last 6 months, is NOT considered an unstable chronic illness. Participant's or parent's/caregiver's verbal report will suffice as documentation.
Participation in research involving an investigational product (drug/biologic/device) administered within 45 days prior to first study vaccination.
History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19. A previous diagnosis of COVID-19 during participation in this trial is not exclusionary for the Booster Amendment.
Received any vaccine within 4 days prior to first study vaccination or planned receipt of any vaccine before Day 49 (i.e., 28 days after second vaccination), except for influenza vaccination, which may be received ≥ 4 days prior to or ≥ 7 days after either study vaccination. Rabies vaccine, at any time it is medically indicated, is not exclusionary. Prior receipt of another approved or authorized COVID-19 vaccine prior to booster injection is not exclusionary in the Booster Amendment. Such participants must provide documentation of vaccine and date(s) of administration.
Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) or therapy that causes clinically significant immunosuppression. NOTE: Stable endocrine disorders (eg, thyroiditis, pancreatitis, including stable diabetes mellitus) are NOT excluded.
Chronic administration (defined as > 14 continuous days) of immunosuppressant or systemic glucocorticoids causing clinically significant immunocompromise, within 90 days prior to first study vaccination and/or third (booster) vaccination. NOTE: An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 20 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporin are permitted.
Received immunoglobulin or blood-derived products, within 90 days prior to first study vaccination and/or third (booster) vaccination.
Active cancer (malignancy) on chemotherapy that is judged to cause clinically significant immunocompromise within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator). This criterion is not applicable to participants diagnosed during participation in this trial who accept participation in the Booster Amendment.
Any known allergies to products contained in the investigational product.
Participants who are breastfeeding, pregnant, or who plan to become pregnant within 3 months following last study vaccination.
Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results.
Study team member or first-degree relative of any study team member (inclusive of Sponsor, and study site personnel involved in the study).
Current participation in any other COVID-19 prevention clinical trial.
Adult participants who have not received a full dose of any authorized/approved COVID-19 vaccine and are unable to provide valid documentation of vaccination will be excluded from the Booster Amendment.

Adult and adolescent participants meeting any of the following criteria will be excluded from the substudy:

History of laboratory-confirmed (by PCR or other antigen testing) COVID-19 infection ≤ 4 months prior to entering the substudy.
Known to be clinically significantly immunocompromised.
Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to entering substudy.
Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of substudy.
History of confirmed myocarditis and/or pericarditis since enrollment to the parent study.
Any condition that, in the opinion of the investigator, might pose a health risk to the participant, interfere with protocol compliance or interfere with evaluation of the trial vaccine.
Study team member or immediate family member of any study team member (inclusive of Sponsor, CRO, and study site personnel involved in the conduct or planning of the substudy).

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)	SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)	One dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 0 Booster Vaccination Period.
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Second Booster)	SARS-CoV-2 rS/Matrix-M1 Adjuvant (Second Booster Vaccination)	One dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 0 Second Booster Vaccination Period.
Placebo (Initial Vaccination)	Placebo (Initial Vaccination Period)	2 doses of Placebo (Saline), 1 dose each on Days 0 and 21in Initial Vaccination Period.
Placebo (Crossover Vaccination)	Placebo (Crossover Vaccination period)	One dose of Placebo (Saline) on Day 0 or Day 21 in Crossover Vaccination Period.
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial vaccination)	SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)	2 doses of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21 in Initial Vaccination Period.
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination)	SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period)	One dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 0 or Day 21 in Crossover Vaccination Period.

Primary Outcome Measures

Name	Time	Method
Pediatric Expansion: Reactogenicity Incidence and Severity	Day 0 to Day 27	Reactogenicity incidence and severity (mild, moderate or severe) recorded by all participants on their electronic patient-reported outcome diary application (eDiary) on days of vaccination and subsequent 6 days (total 7 days after each vaccine injection).
Pediatric Expansion: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points until Month 24	Day 90 to Day 750	Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.
Adult Main Study and Pediatric Expansion: Participants with Symptomatic Mild, Moderate, or Severe Coronavirus Disease 2019 (COVID-19)	Day 28 to Day 750	Number of participants with first occurrence of positive (+) polymerase chain reaction (PCR)-confirmed SARS-CoV-2 illness with symptomatic mild, moderate, or severe COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.
Pediatric Expansion: Incidence and Severity of Unsolicited Adverse Events (AEs) Through Day 49	Day 0 to Day 49	Number of participants with mild, moderate, or severe AEs through Day 49 i.e. 28 days after second injection of each set of vaccinations (initial and crossover).
Pediatric Expansion: Incidence and Severity of Serious Adverse Events (SAEs) Through Specified Time Points	Day 90 to Day 750	Number of participants with mild, moderate, or severe SAEs attributed to study vaccine through specified time points approximately every 3 and 6 months.
Pediatric Expansion: Incidence and Severity of Adverse Events of Special Interest (AESIs) Through Specified Time Points	Day 90 to Day 750	Number of participants with mild, moderate, or severe AESIs attributed to study vaccine through specified time points approximately every 3 and 6 months.
Pediatric Expansion: Incidence and Severity of Medically Attended Adverse Events (MAAEs) Through Day 49	Day 0 to Day 49	Number of participants with mild, moderate, or severe MAAEs through Day 49 i.e. 28 days after second injection of each set of vaccinations (initial and crossover).
Pediatric Expansion: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points	Day 90 to Day 750	Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine through specified time points approximately every 3 and 6 months.
Pediatric Expansion: Incidence and Severity of SAEs Attributed to Study Vaccine Through Specified Time Points until Month 24	Day 90 to Day 750	Number of participants with mild, moderate, or severe SAEs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.
Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specified Time Points	Day 35	Number of participants with antibodies to SARS-CoV-2 NP at Day 35 to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.
Pediatric Expansion: Incidence and Severity of AESIs Attributed to Study Vaccine Through Specified Time Points until Month 24	Day 90 to Day 750	Number of participants with mild, moderate, or severe AESIs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.
Pediatric Expansion: Deaths Due to Any Cause	Day 0 to Day 750	Number of participants who died during the study due to any cause.

Secondary Outcome Measures

Name	Time	Method
Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as GMTs at Later Time Points	Day 165 to Day 750	Neutralizing antibody activity as detected by MN as expressed as GMTs at Months 6, 12, 18, and 24.
Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as Geometric Mean Titers (GMTs)	Day 0 to Day 750	Neutralizing antibody activity as detected by microneutralization assay (MN) as expressed as GMTs at Days 0, 35 and at specified time points through EoS.
Adult Main Study and Pediatric Expansion: hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs	Day 0 to Day 750	Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMFRs at Days 0, 35 and at specified time points through EoS.
Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs at Later Time Points	Day 165 to Day 750	Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at Months 6, 12, 18, and 24.
Adult Main Study and Pediatric Expansion: Description of Course, Treatment and Severity of COVID-19	Day 28 to Day 750	Description of course, treatment and severity of COVID-19 reported after a PCR-confirmed case via the Endpoint Form.
Adult Main Study : Deaths Due to Any Cause	Day 0 to Day 750	Number of participants who died during the study due to any cause.
Adult Main Study and Pediatric Expansion: Participants with Symptomatic Moderate or Severe COVID-19	Day 28 to Day 750	Number of participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with symptomatic moderate or severe COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.
Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs	Day 0 to Day 750	Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMTs at Days 0, 35 and at specified time points through EoS.
Adult Main Study and Pediatric Expansion: Participants with Any Symptomatic COVID-19	Day 28 to Day 750	Number of participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with any symptomatic COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.
Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as Geometric Mean Fold Rises (GMFRs)	Day 0 to Day 750	Neutralizing antibody activity as detected by MN as expressed as GMFRs at Days 0, 35 and at specified time points through EoS.
Adult Main Study and Pediatric Expansion: Serum IgG Antibody Levels Expressed as GMFRs	Day 0 to Day 750	Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Days 0, 35 and at specified time points through EoS.
Adult Main Study and Pediatric Expansion: Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as GMTs	Day 0 to Day 750	Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMTs at Days 0, 35 and at specified time points through EoS.
Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMFRs at Later Time Points	Day 165 to Day 750	Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Months 6, 12, 18, and 24.
Adult Main Study and Pediatric Expansion: hACE2 Receptor Binding Inhibition Assay Expressed as GMTs at Later Time Points	Day 165 to Day 750	Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMTs at Months 6, 12, 18, and 24.
Adult Main Study and Pediatric Expansion: hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs at Later Time Points	Day 165 to Day 750	Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMFRs at Months 6, 12, 18, and 24.
Adult Main Study: Incidence and Severity of Adverse Events of Special Interest (AESIs) Attributed to Study Vaccine Through Specified Time Points	Day 90 to Day 750	Number of participants with mild, moderate, or severe AESIs attributed to study vaccine through specified time points approximately every 3 months.
Adult Main Study and Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Any Time Point	Day 0 to Day 750	Number of participants with antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic.
Adult Main Study: IgG antibodies to SARS-CoV-2 rS at Day 35 After First Crossover Vaccination	Day 35 after the first crossover vaccination	The ratio of geometric mean IgG antibody concentrations will be computed at Day 35 for the new manufacturing process versus the old manufacturing process using the data collected from 300 active vaccine recipients 18 to ≤ 64 years of age enrolled at selected study sites.
Adult Main Study and Pediatric Expansion: Participants with 1st episode of positive Polymerase Chain Reaction (PCR) for Coronavirus Disease 2019 (COVID-19) due to a variant not considered as a "variant of concern/interest"	Day 28 to Day 750	Number of participants with first episode of PCR-positive COVID-19, as defined under the primary endpoint, shown by gene sequencing to represent a variant not considered as a "variant of concern/interest" according to the CDC Variants Classification.
Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as GMFRs at Later Time Points	Day 165 to Day 750	Neutralizing antibody activity as detected by MN as expressed as GMFRs at Months 6, 12, 18, and 24.
Adult Main Study: Reactogenicity Incidence and Severity	Day 0 to Day 27	Reactogenicity incidence and severity (mild, moderate or severe) recorded by all participants on their electronic patient-reported outcome diary application (eDiary) on days of vaccination and subsequent 6 days (total 7 days after each vaccine injection).
Adult Main Study: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points	Day 90 to Day 750	Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine through specified time points approximately every 3 months.
Adult Main Study: Incidence and Severity of Serious Adverse Events (SAEs) Attributed to Study Vaccine Through Specified Time Points	Day 90 to Day 750	Number of participants with mild, moderate, or severe SAEs attributed to study vaccine through specified time points approximately every 3 months.
Adult Main Study: Incidence and Severity of SAEs Attributed to Study Vaccine Through Specified Time Points until Month 24	Day 90 to Day 750	Number of participants with mild, moderate, or severe SAEs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.
Adult Main Study and Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specified Time Points	Day 0 to Day 750	Number of participants with antibodies to SARS-CoV-2 NP at Days 0 and 35, or at specified time points through EoS to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.
Adult Main Study: Incidence and Severity of Medically Attended Adverse Events (MAAEs) Through Day 49	Day 0 to Day 49	Number of participants with mild, moderate, or severe MAAEs through Day 49 i.e. 28 days after second injection of each set of vaccinations (initial and crossover).
Adult Main Study: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points until Month 24	Day 360 to Day 750	Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.
Adult Main Study: Incidence and Severity of Unsolicited Adverse Events (AEs) Through Day 49	Day 0 to Day 49	Number of participants with mild, moderate, or severe AEs through Day 49 i.e. 28 days after second injection of each set of vaccinations (initial and crossover).
Adult Main Study: Incidence and Severity of AESIs Attributed to Study Vaccine Through Specified Time Points until Month 24	Day 360 to Day 750	Number of participants with mild, moderate, or severe AESIs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.

Trial Locations

Locations (137): Atlanta - Morehouse School of Medicine (Adult Site)
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Atlanta, Georgia, United States
Synexus Clinical Research US, Inc (Adult Site)
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Chicago, Illinois, United States
Beth Israel Deaconess Medical Center (Adult Site)
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Boston, Massachusetts, United States
Ventavia Research Group, LLC (Pediatric Site)
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Houston, Texas, United States
Miami Veterans Affairs Medical Center (Adult Site)
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Miami, Florida, United States
Clinical Research Consortium (Adult Site)
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Las Vegas, Nevada, United States
University of Minnesota (Adult Site)
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Minneapolis, Minnesota, United States
University of Texas Health Science Center San Antonio (Adult Site)
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San Antonio, Texas, United States
Clinical Research Associates (Pediatric Site)
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Nashville, Tennessee, United States
Clinical and Translational Research Center at Meharry Medical College (Adult Site)
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Nashville, Tennessee, United States
Wayne State University/ Children's Hospital of Michigan (Adult Site)
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Detroit, Michigan, United States
Central Research Associates, Inc (Pediatric Site)
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Birmingham, Alabama, United States
Alabama Clinical Therapeutics, Llc (Pediatric Site)
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Birmingham, Alabama, United States
Accel Research Sites (Adult Site)
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Birmingham, Alabama, United States
The Pain Center of Arizona (Adult Site)
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Phoenix, Arizona, United States
Foothills Research Center-CCT Research (Pediatric Site)
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Phoenix, Arizona, United States
Premier Health Research Center, Llc (Pediatric Site)
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Downey, California, United States
Meridian Clinical Research (Pediatric Site)
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Binghamton, New York, United States
Suncoast Research Associates, LLC (Adult Site)
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Miami, Florida, United States
Acevedo Clinical Research Associates (Pediatric Site)
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Miami, Florida, United States
Comprehensive Clinical Trials, Llc (Pediatric & Adult site)
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West Palm Beach, Florida, United States
Advanced Clinical Research - Rancho Paseo (Pediatric & Adult Site)
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Banning, California, United States
Anaheim Clinical Trials (Adult Site)
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Anaheim, California, United States
eStudySite - Corporate Offices (Adult Site)
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La Mesa, California, United States
Empire Clinical Research (Pediatric & Adult Site)
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Pomona, California, United States
Alliance for Multispecialty Research, LLC (Adult Site)
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Tempe, Arizona, United States
Lynn Institute of the Ozarks (Adult Site)
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Little Rock, Arkansas, United States
SIMED Health, LLC / SIMED Research (Adult Site)
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Gainesville, Florida, United States
Dignity Health Medical Foundation - Woodland (Adult Site)
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Woodland, California, United States
Synexus USA (Adult Site)
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Evansville, Indiana, United States
Clinical Research Atlanta (Adult Site)
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Stockbridge, Georgia, United States
National Research Institute (Pediatric & Adult Site)
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Los Angeles, California, United States
California Research Foundation (Pediatric & Adult Site)
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San Diego, California, United States
Orange County Research Institute (Pediatric Site)
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Ontario, California, United States
Benchmark Research (Pediatric & Adult Site)
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Fort Worth, Texas, United States
Atlanta Center for Medical Research (Adult Site)
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Atlanta, Georgia, United States
Cedar Crosse Research Center (Adult Site)
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Chicago, Illinois, United States
Columbus Regional Research Institute (Adult Site)
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Columbus, Georgia, United States
Meridien Research/Accel Research (Pediatric & Adult site)
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Lakeland, Florida, United States
M D Clinical (Adult Site)
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Hallandale Beach, Florida, United States
Jacksonville Center for Clinical Research (Pediatric & Adult Site)
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Jacksonville, Florida, United States
Lynn Institute of the Rockies (Adult Site)
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Colorado Springs, Colorado, United States
University Clinical Research-Deland, LLC dba Accel Research Sites (Pediatric & Adult Site)
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DeLand, Florida, United States
Emory University Hospital (Adult Site)
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Atlanta, Georgia, United States
Tekton Research, Inc. (Pediatric Site)
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San Antonio, Texas, United States
Johnson County Clin-Trials, Inc. (Pediatric & Adult Site)
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Lenexa, Kansas, United States
Meridian Clinical Research (Adult Site)
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Sioux City, Iowa, United States
Providea Health Partners LLC (Adult Site)
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Evergreen Park, Illinois, United States
Buynak Clinical Research, P.C. (Pediatric & Adult Site)
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Valparaiso, Indiana, United States
Med Pharmics, LLC (Pediatric & Adult Site)
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Metairie, Louisiana, United States
Alliance for Multispecialty Research (AMR) (Pediatric Site)
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Newton, Kansas, United States
Meridian Clinical Research Baton Rouge (Pediatric Site)
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Baton Rouge, Louisiana, United States
Willis-Knighton Physician Network (Adult Site)
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Shreveport, Louisiana, United States
Kentucky Pediatric/Adult Research (Pediatric Site)
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Bardstown, Kentucky, United States
AMR Wichita East (Formerly Heartland Research Associates) (Pediatric SIte)
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Wichita, Kansas, United States
Meridian Clinical Research, LLC (Adult Site)
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Baton Rouge, Louisiana, United States
c/o The Pediatric Center of Frederick LLC (Adult & Pediatric Site)
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Baltimore, Maryland, United States
The Curators of University of Missouri (Adult Site)
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Columbia, Missouri, United States
Meridian Clinical Research (Adult & Pediatric Site)
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Norfolk, Nebraska, United States
Stony Brook Responder Vaccine Program (Adult Site)
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Commack, New York, United States
Sundance Clinical Research, LLC (Pediatric & Adult Site)
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Saint Louis, Missouri, United States
MedPharmics, LLC-Biloxi (Pediatric & Adult Site)
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Gulfport, Mississippi, United States
Centex Studies, Inc (Adult Site)
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McAllen, Texas, United States
Preferred Primary Care Physicians, Inc. (Pediatric Site)
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Pittsburgh, Pennsylvania, United States
Dr. Shelly David Senders MD Inc. dba Senders Pediatrics (Pediatric Site)
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Cleveland, Ohio, United States
Texas Center for Drug Development, Inc (Pediatric & Adult Site)
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Houston, Texas, United States
M3 Wake Research, Inc (Adult Site)
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Raleigh, North Carolina, United States
Clinical Research Center of Nevada (Pediatric Site)
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Las Vegas, Nevada, United States
M3-Emerging Medical Research, LLC (Pediatric & Adult Site)
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Durham, North Carolina, United States
Womack Army Medical Center (Adult Site)
🇺🇸
Fort Bragg, North Carolina, United States
PMG Research of Rocky Mount, LLC (Adult Site)
🇺🇸
Rocky Mount, North Carolina, United States
Rochester Clinical Research (Pediatric & Adult Site)
🇺🇸
Rochester, New York, United States
Synexus Clinical Research, US, Inc. (Adult Site)
🇺🇸
Akron, Ohio, United States
Sterling Research Group, Ltd. (Adult Site)
🇺🇸
Cincinnati, Ohio, United States
The Charlotte-Mecklenburg Hospital Authority d/b/a Atrium Health (Pediatric & Adult Site)
🇺🇸
Charlotte, North Carolina, United States
PMG Research of Wilmington, LLC (Adult Site)
🇺🇸
Wilmington, North Carolina, United States
Wake Forest Health Network - Pediatrics - Ford, Simpson, Lively & Rice (Pediatric Site)
🇺🇸
Salem, North Carolina, United States
Lynn Health Science Institute (Pediatric & Adult Site)
🇺🇸
Oklahoma City, Oklahoma, United States
Aventiv Research Inc (Pediatric Site)
🇺🇸
Columbus, Ohio, United States
AES San Antonio (Adult Site)
🇺🇸
San Antonio, Texas, United States
Accellacare US Inc., d/b/a Accellacare of Knoxville (Adult Site)
🇺🇸
Knoxville, Tennessee, United States
Holston Medical Group (Pediatric Site)
🇺🇸
Kingsport, Tennessee, United States
American Indian Clinical Trials Research Network (Pediatric & Adult Site)
🇺🇸
Eagle Butte, South Dakota, United States
The Miriam Hospital (TMH) (Adult Site)
🇺🇸
Providence, Rhode Island, United States
Omega Medical Research, Providence (Pediatric & Adult Site)
🇺🇸
Warwick, Rhode Island, United States
The University Of Texas Medical Branch (Utmb) (Pediatric Site)
🇺🇸
League City, Texas, United States
Spartanburg Medical Research (Pediatric Site)
🇺🇸
Spartanburg, South Carolina, United States
Coastal Carolina Research Center (Pediatric Site)
🇺🇸
North Charleston, South Carolina, United States
Advanced Clinical Research (Adult Site)
🇺🇸
West Jordan, Utah, United States
University of Washington VTEU (Adult Site)
🇺🇸
Seattle, Washington, United States
Accellacare of Bristol (Pediatric & Adult Site)
🇺🇸
Bristol, Tennessee, United States
Wee Care Pediatrics (Pediatric Site)
🇺🇸
Syracuse, Utah, United States
DM Clinical Research (Pediatric & Adult Site)
🇺🇸
Tomball, Texas, United States
PanAmerican Clinical Research Mexico S.A de C.V (Adult Site)
🇲🇽
Guadalajara, Jalisco, Mexico
Research Your Health (Pediatric & Adult site)
🇺🇸
Plano, Texas, United States
Health Research of Hampton Roads, Inc (Pediatric & Adult Site)
🇺🇸
Newport News, Virginia, United States
Pediatric Research of Charlottesville, LLC (Pediatric Site)
🇺🇸
Charlottesville, Virginia, United States
Instituto Nacional de Salud Publica (INSP) - Cuernavaca - Centro de Investigacion en Salud Poblacional (CISP) (Adult Site)
🇲🇽
Cuernavaca, Morelos, Mexico
MultiCare Institute for Research & Innovation (Adult Site)
🇺🇸
Cheney, Washington, United States
Caimed Investigacion en Salud S.A. de C.V. (Adult Site)
🇲🇽
Mexico City, Mexico
University of Puerto Rico Medical Sciences Campus Maternal Infant Studies Center (Adult Site)
🇵🇷
San Juan, Puerto Rico
FAICIC S. DE R.L. DE C.V. (Adult Site)
🇲🇽
Veracruz, Mexico
Ponce Medical School Foundation Inc. / CAIMED Cneter (Pediatric & Adult Site)
🇵🇷
Ponce, Puerto Rico
Medical Research International (Adult Site)
🇺🇸
Oklahoma City, Oklahoma, United States
Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare (Pediatric & Adult Site)
🇺🇸
Memphis, Tennessee, United States
WR-PRI, LLC (Adult Site)
🇺🇸
Los Alamitos, California, United States
Sterling Research Group, Ltd (Pediatric & Adult Site)
🇺🇸
Cincinnati, Ohio, United States
Office Of John S. Curran MD (Adult Site)
🇺🇸
Tampa, Florida, United States
Asclepes Research Centers (Adult & Pediatric Site)
🇺🇸
Spring Hill, Florida, United States
Synexus Clinical Research US, Inc. (Adult Site)
🇺🇸
Anderson, South Carolina, United States
Paradigm Clinical Research Centers, Inc (Pediatric Site)
🇺🇸
La Mesa, California, United States
Coast Clinical Research, LLC (Pediatric Site)
🇺🇸
Bellflower, California, United States
Velocity Clinical Research (Pediatric & Adult Site)
🇺🇸
Medford, Oregon, United States
Preferred Research Partners, Inc. (Adult Site)
🇺🇸
Little Rock, Arkansas, United States
Advanced Clinical Research (Pediatric & Adult Site)
🇺🇸
Meridian, Idaho, United States
Howard University Hospital Howard/ University College of Medicine (Adult Site)
🇺🇸
Washington, District of Columbia, United States
The University of Iowa Hospitals & Clinics (Adult Site)
🇺🇸
Iowa City, Iowa, United States
Weill Cornell Chelsea CRS (Adult Site)
🇺🇸
New York, New York, United States
WR Clinsearch, LLC (Pediatric & Adult Site)
🇺🇸
Chattanooga, Tennessee, United States
DM Clinical Research - Pediatric Healthcare of NW Houston, P.A. (Pediatric Site)
🇺🇸
Houston, Texas, United States
Baylor College of Medicine (Adult Site)
🇺🇸
Houston, Texas, United States
CAIMED Investigacion en Salud S.A de C.V (Adult Site)
🇲🇽
Mexico City, Mexico
Unidad de Atencion Medica e Investigacion en Salud (UNAMIS) (Adult Site)
🇲🇽
Merida, Yucatan, Mexico
PanAmerican Clinical Research Mexico (Adult Site)
🇲🇽
Juriquilla, Queretaro, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Adult Site)
🇲🇽
Mexico City, Mexico
University of California Davis Health (Pediatric & Adult Site)
🇺🇸
Sacramento, California, United States
Headlands Research Orlando (Adult Site)
🇺🇸
Orlando, Florida, United States
Tampa Heart & Cardiovascular Center (Adult Site)
🇺🇸
Tampa, Florida, United States
University of Colorado Clinical and Translational Research Centers (Pediatric & Adult Site)
🇺🇸
Aurora, Colorado, United States
Brownsboro Park Pediatrics (Pediatric Site)
🇺🇸
Louisville, Kentucky, United States
VA Ann Arbor Healthcare System (Adult Site)
🇺🇸
Ann Arbor, Michigan, United States
Meridian Clinical Research Associates, LLC (Pediatric & Adult Site)
🇺🇸
Omaha, Nebraska, United States
University Of Nebraska Medical Center (Pediatric & Adult Site)
🇺🇸
Omaha, Nebraska, United States
Clinical Neuroscience Solutions Inc (Pediatric & Adult Site)
🇺🇸
Orlando, Florida, United States
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill (Pediatric & Adult Site)
🇺🇸
Chapel Hill, North Carolina, United States
Medical University of South Carolina, SCTR Research Nexus (Adult Site)
🇺🇸
Charleston, South Carolina, United States
Carolina Institute for Clinical Research (Adult Site)
🇺🇸
Fayetteville, North Carolina, United States

A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to<18 Years) at Risk for SARS-CoV-2

Recruitment & Eligibility

Study & Design

Trial Locations

Instant Trial Alerts

Instant Trial Alerts