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NCT07086222 · ClinicalTrials.gov registry record · Phase 4

Efficacy and Safety of NVX-CoV2705

A Phase 4 study, sponsored by Novavax.

Active
Registry status
Phase 4
Development phase
6,500
Enrollment target

NCT07086222: Active Phase 4 study, sponsored by Novavax.

NCT07086222 is a Phase 4 study that is active but no longer recruiting, run by Novavax. The registered enrollment target is 6,500 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (1155% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07086222, a Phase 4 study, is active but no longer recruiting, sponsored by Novavax.

ACTIVE NOT RECRUITING
Registry status
Phase 4
Development phase
6,500 participants
Enrollment target

Study Summary

This is a Phase 4, post-market US study, evaluating the efficacy and safety of a single dose of the NVX-CoV2705 Omicron JN.1 COVID-19 vaccine. Approximately 6,500 healthy adults aged 50 to under 65 will be randomized to receive either the vaccine or a placebo, with follow-up for 180 days.

Primary Outcome

First episode of PCR-positive symptomatic COVID 19 from Day 0 (post vaccination) through Day 180/EoS

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL NVX-CoV2705

Trial Details

FieldValue
Enrollment Target 6,500 participants
Start Date 2025-11-20
Est. Completion 2026-11-18
Phase Phase 4
Novavax

31 total trials

What the registry record for NCT07086222 still lists

NCT07086222 is an interventional study that assigns participants to a tested intervention. Its 6,500 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (1155% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT07086222 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07086222 about?

NCT07086222 is a clinical study titled "Efficacy and Safety of NVX-CoV2705". This is a Phase 4, post-market US study, evaluating the efficacy and safety of a single dose of the NVX-CoV2705 Omicron JN.1 COVID-19 vaccine. Approximately 6,500 healthy adults aged 50 to under 65 will be randomized to receive either the vaccine or a placebo, with follow-up for 180 days.

What is the current status of trial NCT07086222?

This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 6,500 participants. The study started on 2025-11-20. Estimated completion is 2026-11-18.

What interventions are being tested in trial NCT07086222?

The interventions under investigation include: Placebo (BIOLOGICAL), NVX-CoV2705 (BIOLOGICAL).

Who is sponsoring clinical trial NCT07086222?

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

How this trial's enrollment target compares

Where NCT07086222's enrollment target sits among peer trials

6,500 12th of 2000 higher than 1,989 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT07086222, the US trial registry maintained by the National Library of Medicine. NCT07086222 (large enrollment · none site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.