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NCT05468736 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years
A Phase 2 study of COVID-19, sponsored by Novavax.
- Active
- Registry status
- Phase 2
- Development phase
- 3,600
- Enrollment target
- 20
- Study locations
NCT05468736 is a Phase 2 study of COVID-19 that is active but no longer recruiting, run by Novavax. The registered enrollment target is 3,600 participants, below the 55,197-participant average among 203 other COVID-19 trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 7 states.
The verdict
NCT05468736, a Phase 2 study of COVID-19, is active but no longer recruiting, sponsored by Novavax.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 3,600 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2/3 randomized, observer-blinded, placebo-controlled, age de-escalation trial to evaluate the safety and immunogenicity of 2 primary doses of SARS-CoV-2 rS with Matrix-M™ adjuvant (NVX-CoV2373) given 21 days apart and NVX CoV2373 or a variant-based vaccine given as a booster dose or at crossover in pediatric participants (3 age cohorts; 6 to \< 12 years, 2 to \< 6 years, and 6 to \< 24 months of age). Each age cohort will be conducted in 2 parts starting with the oldest age cohort (6 to \< 12 years of age).
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
Study Locations (20)
California
- Advanced Research Center - Anaheim
- Coast Clinical Research, LLC - Bellflower
- Apex Research Group - Fair Oaks
- Ark Clinical Research - Long Beach
- Orange County Research Institute - Ontario
- California Research Foundation - San Diego
- Clinical Research of California - Walnut Creek
Florida
- Imagine Research of Palm Beach County - Boynton Beach
- Palm Harbor Dermatology PA - Brandon
- Westside Center for Clinical Research - Jacksonville
- Cordova Research Institute, LLC - Miami
- ARS-Nona Pediatric Center - Orlando
Georgia
- Morehouse School of Medicine - Atlanta
- Tekton Research - Atlanta - Chamblee
Kentucky
- Michael W. Simon, M.D., PSC - Lexington
- Bluegrass Clinical Research, Inc./All Children Pediatrics - Louisville
Louisiana
- Velocity Clinical Research - Covington, LA - Covington
- Velocity Clinical Research - Covington - Covington
Arkansas
- Preferred Research Partners, Inc. - Little Rock
Idaho
- Leavitt Clinical Research - Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,600 participants |
| Start Date | 2022-07-22 |
| Est. Completion | 2025-10-25 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05468736
The ClinicalTrials.gov registry entry for NCT05468736 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 3,600 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,197-participant average among 203 other COVID-19 trials with a reported enrollment target (93% lower). The listed sponsor is Novavax, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05468736 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT05468736 about?
NCT05468736 is a clinical study titled "Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years". This is a Phase 2/3 randomized, observer-blinded, placebo-controlled, age de-escalation trial to evaluate the safety and immunogenicity of 2 primary doses of SARS-CoV-2 rS with Matrix-M™ adjuvant (NVX-CoV2373) given 21 days apart and NVX CoV2373 or a variant-based vaccine given as a booster dose or ...
What is the current status of trial NCT05468736?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 3,600 participants. The study started on 2022-07-22. Estimated completion is 2025-10-25.
What conditions does trial NCT05468736 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT05468736?
The interventions under investigation include: Placebo (OTHER), SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05468736?
This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05468736 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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