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

NCT05468736 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 3600

Last updated 2026-05-22

No results posted yet for this 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

Interventions

BIOLOGICAL

SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)

Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) (or fractional dose if necessary) on Days 0 and 21 in the Initial Vaccination Period.

OTHER

Placebo

Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21 in the Initial Vaccination Period or on Days 201 or Day 229 in the Booster Vaccination Period

Sponsors & Collaborators

  • Novavax

    lead INDUSTRY

Principal Investigators

  • Clinical Development · Novavax, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
6 Months
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-22
Primary Completion
2024-01-16
Completion
2025-10-25
FDA Drug
Yes

Countries

  • United States
  • Colombia
  • Dominican Republic
  • Guatemala
  • Honduras
  • Mexico
  • Philippines
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05468736 on ClinicalTrials.gov