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NCT05925127 · ClinicalTrials.gov registry record · Phase 2

Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines

A Phase 2 study, sponsored by Novavax.

Completed
Registry status
Phase 2
Development phase
994
Enrollment target

NCT05925127: Completed Phase 2 study, sponsored by Novavax.

NCT05925127 is a Phase 2 study that has completed, run by Novavax. The registered enrollment target is 994 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (647% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05925127, a Phase 2 study, has completed, sponsored by Novavax.

COMPLETED
Registry status
Phase 2
Development phase
994 participants
Enrollment target

Study Summary

This is a Phase 2/3, randomized, double-blind study to evaluate the safety and immunogenicity of different booster dose levels of the monovalent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle (SARS-CoV-2 rS) vaccines with Matrix-M™ adjuvant (NVX-CoV2373 \[prototype Wuhan vaccine with Matrix-M adjuvant\] or NVX-CoV2601 \[Omicron XBB.1.5 subvariant vaccine with Matrix-M adjuvant\]).

Primary Outcome

Neutralizing antibody To determine if the combination of antigen and adjuvant levels of NVX-CoV2601 GMTR against the Omicron subvariant XBB.1.5 superior(LB of the 95% CI for GMTR \> 1.0) to that elicited by NVX-CoV2373

Interventions

  • BIOLOGICAL NVX-CoV2373 (5μg)
  • BIOLOGICAL NVX-CoV2601 (5μg)
  • BIOLOGICAL NVX-CoV2601(5μg)
  • BIOLOGICAL NVX-CoV2601 (35μg)
  • BIOLOGICAL NVX-CoV2601(35μg)

Trial Details

FieldValue
Enrollment Target 994 participants
Start Date 2023-10-16
Est. Completion 2024-05-21
Phase Phase 2
Novavax

31 total trials

What the finished NCT05925127 record still lists

NCT05925127 is an interventional study that assigns participants to a tested intervention. The registered 994 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (647% higher).

The record links to 0 conditions, and to 5 interventions - of which NVX-CoV2373 (5μg) is the first listed.

NCT05925127 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05925127 about?

NCT05925127 is a clinical study titled "Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines". This is a Phase 2/3, randomized, double-blind study to evaluate the safety and immunogenicity of different booster dose levels of the monovalent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle (SARS-CoV-2 rS) vaccines with Matrix-M™ adjuvan...

What is the current status of trial NCT05925127?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 994 participants. The study started on 2023-10-16. Estimated completion is 2024-05-21.

What interventions are being tested in trial NCT05925127?

The interventions under investigation include: NVX-CoV2373 (5μg) (BIOLOGICAL), NVX-CoV2601 (5μg) (BIOLOGICAL), NVX-CoV2601(5μg) (BIOLOGICAL), NVX-CoV2601 (35μg) (BIOLOGICAL), NVX-CoV2601(35μg) (BIOLOGICAL).

Who is sponsoring clinical trial NCT05925127?

This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05925127's enrollment target sits among peer trials

994 26th of 2000 higher than 1,975 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT05925127, the US trial registry maintained by the National Library of Medicine. NCT05925127 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.