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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Participants With Solicited Local and Systemic AEs for 7 Days Following Vaccination
Timeframe: Day 7
Participants With Unsolicited AEs Through 28 Days After Vaccination
Timeframe: Day 28
Participants With (MAAEs) Attributed to Study Vaccine, (AESIs) (PIMMCs), Myocarditis and/or Pericarditis, and Complications Specific to COVID-19), and Serious Adverse Events (SAEs)
Timeframe: Day 180
Immunogenicity Index- Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain.
Timeframe: Day 0 and Day 28
Immunogenicity Index- The Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain.
Timeframe: Day 28