NCT04611802Phase 3Completed

A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to<18 Years) at Risk for SARS-CoV-2

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 completion2023-04-10Actual

Enrollment · participants33000Actual

Source updated2023-12-21Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

SARS-CoV Infection; Covid19

Treatments or interventions studied

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

Primary outcomes · main study measures

Read the study measures

measure: Adult Main Study and Pediatric Expansion: Participants with Symptomatic Mild, Moderate, or Severe Coronavirus Disease 2019 (COVID-19); description: Number of participants with first occurrence of positive (+) polymerase chain reaction (PCR)-confirmed SARS-CoV-2 illness with symptomatic mild, moderate, or severe COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.; timeFrame: Day 28 to Day 750; measure: Pediatric Expansion: Reactogenicity Incidence and Severity; description: Reactogenicity incidence and severity (mild, moderate or severe) recorded by all participants on their 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 27; measure: Pediatric Expansion: Incidence and Severity of Medically Attended Adverse Events (MAAEs) Through Day 49; description: Number of participants with mild, moderate, or severe MAAEs through Day 49 i.e. 28 days after second injection of each set of vaccinations (initial and crossover).; timeFrame: Day 0 to Day 49; measure: Pediatric Expansion: Incidence and Severity of Unsolicited Adverse Events (AEs) Through Day 49; description: Number of participants with mild, moderate, or severe AEs through Day 49 i.e. 28 days after second injection of each set of vaccinations (initial and crossover).; timeFrame: Day 0 to Day 49; measure: Pediatric Expansion: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points; description: Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine through specified time points approximately every 3 and 6 months.; timeFrame: Day 90 to Day 750; measure: Pediatric Expansion: Incidence and Severity of Serious Adverse Events (SAEs) Through Specified Time Points; description: Number of participants with mild, moderate, or severe SAEs attributed to study vaccine through specified time points approximately every 3 and 6 months.; timeFrame: Day 90 to Day 750; measure: Pediatric Expansion: Incidence and Severity of Adverse Events of Special Interest (AESIs) Through Specified Time Points; description: Number of participants with mild, moderate, or severe AESIs attributed to study vaccine through specified time points approximately every 3 and 6 months.; timeFrame: Day 90 to Day 750; measure: Pediatric Expansion: Incidence and Severity of SAEs Attributed to Study Vaccine Through Specified Time Points until Month 24; description: Number of participants with mild, moderate, or severe SAEs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.; timeFrame: Day 90 to Day 750; measure: Pediatric Expansion: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points until Month 24; description: Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.; timeFrame: Day 90 to Day 750; measure: Pediatric Expansion: Incidence and Severity of AESIs Attributed to Study Vaccine Through Specified Time Points until Month 24; description: Number of participants with mild, moderate, or severe AESIs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.; timeFrame: Day 90 to Day 750; measure: Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specified Time Points; description: Number of participants with antibodies to SARS-CoV-2 NP at Day 35 to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.; timeFrame: Day 35; measure: Pediatric Expansion: Deaths Due to Any Cause; description: Number of participants who died during the study due to any cause.; timeFrame: Day 0 to Day 750

History coverage

Imported research includes version dates later than the current official API record (2023-12-21). Disputed observations are retained for audit and excluded from trusted change feeds and sponsor statistics. 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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