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ACTIVE NOT RECRUITING Phase 2

Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years

NCT05468736 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 3,600 participants
Start Date 2022-07-22
Est. Completion 2025-10-25
Phase Phase 2

Sponsor

Novavax

8 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3,600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novavax, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05468736 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05468736?

This trial is sponsored by Novavax, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial