Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older

Summary

The primary objectives of the study are:

To assess the safety profile of the study vaccines in each study intervention group.

To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults.

To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a twodose priming series with the monovalent vaccine, and superior to that observed immediately before booster.

The secondary objectives of the study are:

To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study.

To assess the neutralizing and binding antibody responses of booster vaccination.

To describe the occurrences of laboratory-confirmed symptomatic COVID19 after primary series and booster vaccination.

To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination.

Conditions

• COVID-19

Interventions

BIOLOGICAL

SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 1

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 2

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 3

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 4

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Sponsors & Collaborators

• GlaxoSmithKline

  collaborator INDUSTRY

• Sanofi Pasteur, a Sanofi Company

  lead INDUSTRY

Principal Investigators

• Clinical Sciences & Operations · Sanofi

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-02-24

Primary Completion

2023-06-29

Completion

2023-06-29

FDA Drug

Yes

Countries

• United States
• Australia
• France
• Honduras
• New Zealand
• Spain
• United Kingdom

Study Locations