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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 is a Phase 3 study that has completed, run by Novavax. The registered enrollment target is 400 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05973006
The ClinicalTrials.gov registry entry for NCT05973006 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novavax, which has 31 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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