Description of Collaborative Activity: |
In this ancillary swab study, up to 3,000 adolescent participants 12-17 years of age who participated in the Pre-fusion Protein Subunit Vaccine Efficacy Novavax Trial COVID-19 (PREVENT-19) Pediatric Expansion study and who provided informed consent/assent for the ancillary swab study were sampled twice weekly starting at the day 21 visit, or as soon as possible thereafter, of the initial injection period until the second dose of the blinded cross-over (approximately 28 weeks) with nasal swabs for detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection by reverse transcription polymerase chain reaction (RT-PCR) and incident infections tallied. Data sources from the Observational Study (e.g., study product assignment, daily symptomatology) will be used in the ancillary study to estimate the vaccine efficacy against SARS-CoV-2 infection, including asymptomatic infection or mildly symptomatic infection not meeting the Coronavirus Disease 2019 (COVID-19) primary endpoint definition for the Phase 3 study. |
