drugset / Trial / NCT05973006

Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines

NCT05973006

Phase 3 Completed 400 enrolled Novavax
RandomizedParallel-groupDouble-blindPrevention

Summary

This study is a large-scale investigation (Phase 3) into a new booster shot designed specifically for teenagers. The booster targets a particular variant of COVID-19, Omicron XBB.1.5. The main focus is on safety: researchers want to see if this new booster is safe for teenagers who have already received two doses of the Pfizer or Moderna mRNA COVID-19 vaccines. To ensure a fair comparison, the study will use a double-blind approach. This means two groups of teenagers will receive booster shots, but neither the teenagers nor the researchers giving the shots will know beforehand which version of the booster each person gets. The study will also assess how well the body fights the virus after the booster shot.

Timeline

Start
2023-08-16
Primary completion
2024-04-01
Completion
2024-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject MIVALSECOVATEIN Vaccine 2.5 ug Other
Subject MIVALSECOVATEIN Vaccine 5 ug Other
Comparator NVX-CoV2373 Vaccine 2.5 ug Other

Indications