NCT05468736Phase 2, phase 3Completed

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

Study sponsor: Novavax

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2024-01-16Actual

Enrollment · participants3600Actual

Source updated2026-05-22Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-05-22 · 2 fields changed

Participant count type changed

− Before

~~Estimated~~

+ After

Actual

Recruitment status changed

− Before

~~Active not recruiting~~

+ After

Completed

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Study details

Conditions studied

COVID-19

Treatments or interventions studied

SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)BiologicalAlso known as NVX-CoV2373

Primary outcomes · main study measures

Read the study measures

measure: Reactogenicity Incidence and Severity; description: Reactogenicity incidence, duration, and severity (mild, moderate, severe, or potentially life-threatening) recorded by parent(s)/caregiver(s) on an electronic patient-reported outcome diary application (eDiary) on days of vaccination and subsequent 6 days (total 7 days after each vaccine injection).; timeFrame: Day 0 to Day 7; measure: Incidence and Severity of Medically Attended Adverse Events (MAAEs); description: Incidence and severity of MAAEs through 28 days after second injection of each set of vaccinations (initial and crossover), and after a booster dose.; timeFrame: Day 0 to Day 28; measure: Incidence and Severity of Unsolicited Adverse Events (AEs); description: Incidence and severity of unsolicited AEs through 28 days after second injection of each set of vaccinations (initial and crossover), and after a booster dose.; timeFrame: Day 0 to Day 28; measure: Incidence and Severity of MAAEs Attributed to Study Vaccine; description: Incidence and severity of MAAEs attributed to study vaccine after initial vaccination at Day 0 through Month 24 or the EoS.; timeFrame: Day 0 to Day 730; measure: Incidence and Severity of Serious Adverse Events (SAEs); description: Incidence and severity of SAEs after initial vaccination at Day 0 through Month 24 or the EoS.; timeFrame: Day 0 to Day 730; measure: Incidence and Severity of Adverse Events of Special Interest (AESIs); description: Incidence and severity of AESIs (including multisystem inflammatory syndrome in children \[MIS-C\], and myocarditis and/or pericarditis) after initial vaccination at Day 0 through Month 24 or the EoS.; timeFrame: Day 0 to Day 730; measure: Death due to any cause; description: Death due to any cause occurring from Day 0 to EoS.; timeFrame: Day 0 to Day 730

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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