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NCT04611802 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of COVID-19 and SARS-CoV Infection, sponsored by Novavax.
- Completed
- Registry status
- Phase 3
- Development phase
- 33,000
- Enrollment target
- 20
- Study locations
NCT04611802: Completed Phase 3 study of COVID-19 and SARS-CoV Infection, sponsored by Novavax.
NCT04611802 is a Phase 3 study of COVID-19 and SARS-CoV Infection that has completed, run by Novavax. The registered enrollment target is 33,000 participants, below the 38,354-participant average among 298 other COVID-19 trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04611802, a Phase 3 study of COVID-19 and SARS-CoV Infection, has completed, sponsored by Novavax.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 33,000 participants
- Enrollment target
- 20
- Study locations
Study 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)
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
- OTHER Placebo (Initial Vaccination Period)
- BIOLOGICAL SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period)
- OTHER Placebo (Crossover Vaccination period)
- BIOLOGICAL SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
Study Locations (20)
California
- Anaheim Clinical Trials (Adult Site) - Anaheim
- Advanced Clinical Research - Rancho Paseo (Pediatric & Adult Site) - Banning
- Coast Clinical Research, LLC (Pediatric Site) - Bellflower
- Velocity Clinical Research (Pediatric & Adult Site) - Chula Vista
- Premier Health Research Center, Llc (Pediatric Site) - Downey
- eStudySite - Corporate Offices (Adult Site) - La Mesa
- Paradigm Clinical Research Centers, Inc (Pediatric Site) - La Mesa
- WR-PRI, LLC (Adult Site) - Los Alamitos
- National Research Institute (Pediatric & Adult Site) - Los Angeles
- Orange County Research Institute (Pediatric Site) - Ontario
- Empire Clinical Research (Pediatric & Adult Site) - Pomona
- University of California Davis Health (Pediatric & Adult Site) - Sacramento
Alabama
- Alabama Clinical Therapeutics, Llc (Pediatric Site) - Birmingham
- Accel Research Sites (Adult Site) - Birmingham
- Central Research Associates, Inc (Pediatric Site) - Birmingham
Arizona
- The Pain Center of Arizona (Adult Site) - Phoenix
- Foothills Research Center-CCT Research (Pediatric Site) - Phoenix
- Alliance for Multispecialty Research, LLC (Adult Site) - Tempe
Arkansas
- Lynn Institute of the Ozarks (Adult Site) - Little Rock
- Preferred Research Partners, Inc. (Adult Site) - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33,000 participants |
| Start Date | 2020-12-27 |
| Est. Completion | 2023-12-15 |
| Phase | Phase 3 |
What the finished NCT04611802 record still lists
NCT04611802 is an interventional study that assigns participants to a tested intervention. Its 33,000 participants enrollment target places it among the larger protocols in the corpus, below the 38,354-participant average among 298 other COVID-19 trials with a reported enrollment target (14% lower).
The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 5 interventions - of which SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period) is the first listed.
NCT04611802 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT04611802 about?
NCT04611802 is a clinical study titled "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". 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 substud...
What is the current status of trial NCT04611802?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 33,000 participants. The study started on 2020-12-27. Estimated completion is 2023-12-15.
What conditions does trial NCT04611802 study?
This clinical trial studies the following conditions: COVID-19, SARS-CoV Infection.
What interventions are being tested in trial NCT04611802?
The interventions under investigation include: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period) (BIOLOGICAL), Placebo (Initial Vaccination Period) (OTHER), SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period) (BIOLOGICAL), Placebo (Crossover Vaccination period) (OTHER), SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04611802?
This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04611802 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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