Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07086222
PHASE4

Efficacy and Safety of NVX-CoV2705

Sponsor: Novavax

View on ClinicalTrials.gov

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.

Official title: A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Post-Marketing Study to Evaluate the Efficacy and Safety of an Omicron JN.1 Subvariant SARS-CoV-2 rS Vaccine Adjuvanted With Matrix-M® in Adults 50 to < 65 Years of Age Without High Risk Conditions for Severe COVID-19

Key Details

Gender

All

Age Range

50 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

6500

Start Date

2025-11-10

Completion Date

2026-07-09

Last Updated

2025-08-03

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

NVX-CoV2705

NVX-CoV2705 vaccine in a 0.5 mL injection volume at an antigenic dose of 5 µg with 50 µg Matrix-M adjuvant

BIOLOGICAL

Placebo

Placebo (normal saline) in a 0.5 mL injection volume.