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NCT05973006 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines
A Phase 3 study, sponsored by Novavax.
- Completed
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
NCT05973006: Completed Phase 3 study, sponsored by Novavax.
NCT05973006 is a Phase 3 study that has completed, run by Novavax. The registered enrollment target is 400 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05973006, a Phase 3 study, has completed, sponsored by Novavax.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
Study 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.
Primary Outcome
Participants with solicited local and systemic adverse events (AEs) To assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) for 7 days following vaccination
Interventions
- BIOLOGICAL NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine
- BIOLOGICAL Prototype/XBB.1.5 Bivalent Vaccine (5 µg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2023-08-16 |
| Est. Completion | 2024-09-30 |
| Phase | Phase 3 |
What the finished NCT05973006 record still lists
NCT05973006 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine is the first listed.
NCT05973006 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05973006 about?
NCT05973006 is a clinical study titled "Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines". 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 rece...
What is the current status of trial NCT05973006?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2023-08-16. Estimated completion is 2024-09-30.
What interventions are being tested in trial NCT05973006?
The interventions under investigation include: NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine (BIOLOGICAL), Prototype/XBB.1.5 Bivalent Vaccine (5 µg) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05973006?
This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05973006's enrollment target sits among peer trials
400 922nd of 2000 higher than 1,039 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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