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Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older

NCT04904549 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23726

Last updated 2024-10-16

No results posted yet for this study

Summary

The purpose of this Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) as part of primary series vaccinations in a multi-stage approach, as well as a booster injection of a CoV2 preS dTM-AS03 vaccine, in adults 18 years of age and older.

A total of approximately 21 046 participants are planned to be enrolled (5080 per study intervention group in Stage 1 and 5443 per study intervention group in Stage 2).

Initial, double-blind, primary series study design is planned for 365 days post-last Initial injection (ie, approximately 386 days total) for each participant.

Based on decisions of the Study Oversight Group, Stage 1 and Stage 2 participants will be invited to participate in an unblinded Crossover / Booster study design with duration as follows:

* For participants who initially received vaccine: 12 months post-booster (ie, approximately 18 to 24 months)
* For participants who initially received placebo: ≥ 4 months post-last dose of the primary series + 12 months post-booster (ie, approximately 28 to 34 months)
* For participants who do not consent to continue in the unblinded Crossover / Booster part of the study, all study procedures will be stopped and participants will be discontinued from the study.

Conditions

Interventions

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent D614) (primary series)

Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine (bivalent D614 + B.1.351) (primary series)

Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.

BIOLOGICAL

Placebo

Pharmaceutical form: liquid. Route of administration: intramuscular administration.

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination

Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent D614)(primary series)& SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent B.1.351)(booster dose)>=4 months after last vaccination

Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-20
Primary Completion
2024-08-31
Completion
2024-08-31
FDA Drug
Yes

Countries

  • United States
  • Colombia
  • Ghana
  • Honduras
  • India
  • Japan
  • Kenya
  • Mexico
  • Nepal
  • Uganda
  • Ukraine

Study Locations

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Entities

Drugs
Diseases

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 NCT04904549 on ClinicalTrials.gov