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Phase 3 Boosting Study for the SARS-CoV-2 rS Vaccine

NCT05249816 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2023-08-02

No results posted yet for this study

Summary

This is an observer-blinded Phase 3 study to evaluate the safety and immunogenicity of a single booster dose of the Novavax severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine adjuvanted with Matrix-MTM (NVX-CoV2373) in adults previously vaccinated with the BBIBP-CorV vaccine. The study will enroll approximately1,000 participants \>18 years of age. All participants will be randomized in a 1:1 ratio to receive a single booster dose of NVX-CoV2373 or the BBIBP-CorV vaccine. All participants will receive the booster dose on Day 0 and remain on study for immunogenicity and safety data collection through Day 180. An interim analysis will be performed of safety and immunogenicity data gathered through Day 28.

Conditions

  • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Interventions

BIOLOGICAL

NVX-CoV2373

A single booster injection of NVX-CoV2373 with Matrix-M adjuvant. 0.5 mL injection volume at a dose of 5μg of antigen with 50 μg Matrix-M adjuvant

BIOLOGICAL

BBIBP-CorV vaccine

BBIBP-CorV vaccine administered per manufacturer instructions.

Sponsors & Collaborators

  • Novavax

    collaborator INDUSTRY

  • Cogna Technology Solutions LLC

    lead INDUSTRY

Principal Investigators

  • Nawal Al Kaabi · Sheikh Khalifa Medical City

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-18
Primary Completion
2023-05-04
Completion
2023-05-04

Countries

  • United Arab Emirates

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05249816 on ClinicalTrials.gov