Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years
Public ClinicalTrials.gov record NCT05468736. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2/3 Age De-escalating Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Vaccine (SARS-CoV-2 rS) With Matrix-M™ Adjuvant in Children 6 Months to < 12 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05468736
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 3,600 participants
Conditions and interventions
Conditions
Interventions
- SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period) Biological
- Placebo Other
Biological · Other
Eligibility (public fields only)
- Age range
- 6 Months to 11 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 22, 2022 (Actual)
- Primary completion
- Jan 16, 2024 (Actual)
- Completion
- Oct 25, 2025 (Actual)
- Last update posted
- May 22, 2026
2022 – 2025
United States locations
- U.S. sites
- 47
- U.S. states
- 19
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Preferred Research Partners, Inc. | Little Rock | Arkansas | 72211 | — |
| Advanced Research Center | Anaheim | California | 92805 | — |
| Coast Clinical Research, LLC | Bellflower | California | 90706 | — |
| Apex Research Group | Fair Oaks | California | 95628 | — |
| Ark Clinical Research | Long Beach | California | 90815 | — |
| Orange County Research Institute | Ontario | California | 91762 | — |
| California Research Foundation | San Diego | California | 92123 | — |
| Clinical Research of California | Walnut Creek | California | 94598 | — |
| Imagine Research of Palm Beach County | Boynton Beach | Florida | 33435 | — |
| Palm Harbor Dermatology PA | Brandon | Florida | 33511 | — |
| Westside Center for Clinical Research | Jacksonville | Florida | 32205 | — |
| Cordova Research Institute, LLC | Miami | Florida | 33155 | — |
| ARS-Nona Pediatric Center | Orlando | Florida | 32829 | — |
| Morehouse School of Medicine | Atlanta | Georgia | 30310 | — |
| Tekton Research - Atlanta | Chamblee | Georgia | 30341 | — |
| Leavitt Clinical Research | Idaho Falls | Idaho | 83404 | — |
| Michael W. Simon, M.D., PSC | Lexington | Kentucky | 40517 | — |
| Bluegrass Clinical Research, Inc./All Children Pediatrics | Louisville | Kentucky | 40243 | — |
| Velocity Clinical Research - Covington, LA | Covington | Louisiana | 70433 | — |
| Velocity Clinical Research - Covington | Covington | Louisiana | 70433 | — |
| Velocity Clinical Research - Lafayette LA | Lafayette | Louisiana | 70508 | — |
| Craig A. Spiegel, M.D. | Bridgeton | Missouri | 63044 | — |
| Boeson Research | Missoula | Montana | 59804 | — |
| Meridian Clinical Research | Lincoln | Nebraska | 68510 | — |
| Be Well Clinical Studies, LLC | Lincoln | Nebraska | 68516 | — |
| Corning Center for Clinical Research | Horseheads | New York | 14845 | — |
| Velocity Clinical Research | Beachwood | Ohio | 44122 | — |
| Dayton Clinical Research | Dayton | Ohio | 45409 | — |
| Senders Pediatrics | South Euclid | Ohio | 44121 | — |
| Lynn Institute of Tulsa | Tulsa | Oklahoma | 74135 | — |
| Velocity Clinical Research Grants Pass | Grants Pass | Oregon | 97527 | — |
| Tribe Clinical Research | Greenville | South Carolina | 29607 | — |
| WR - ClinSearch, LLC | Chattanooga | Tennessee | 37421 | — |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | — |
| Tekton Research Beaumont | Beaumont | Texas | 77706 | — |
| PanAmerican Clinical Research | Brownsville | Texas | 78520 | — |
| South Texas Clinical Research | Corpus Christi | Texas | 78404 | — |
| Bay Colony Pediatrics | Dickinson | Texas | 77539 | — |
| Trio Clinical Trials | Houston | Texas | 77008 | — |
| Mercury Clinical Research | Houston | Texas | 77087 | — |
| Research Your Health | Plano | Texas | 75093 | — |
| Mercury Clinical Research - Pediatric Center | Richmond | Texas | 77469 | — |
| Tekton Research | San Antonio | Texas | 78244 | — |
| Alliance for Multispecialty Research | Layton | Utah | 84041 | — |
| Alliance for Multispecialty Research c/o Wee Care Pediatrics - Roy | Roy | Utah | 84067 | — |
| Velocity Clinical Research - West Jordan | West Jordan | Utah | 84088 | — |
| Clinical Research Partners, LLC | Richmond | Virginia | 23226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 47 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05468736, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 22, 2026 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05468736 live on ClinicalTrials.gov.