NCT04762680

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

Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccines With AS03 Adjuvant in Adults 18 Years of Age and Older as a Primary Series and Immunogenicity and Safety of a Booster Dose of SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (Two Monovalent and One Bivalent)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 3,159 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The duration of each participant's participation in the study will be approximately: Original Phase 2 part: 365 days postinjection 2 (ie, 386 days total). Supplemental Cohorts 1 and 2: 365 days post-booster injection (ie, 366 days total).

Conditions

• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-02-24
• Primary completion: 2023-06-29
• Completion: 2023-06-29
• First posted: 2021-02-21
• Last updated: 2025-09-18
• Results posted: 2025-09-18

Locations

66 sites across 7 countries: United States, Australia, France, Honduras, New Zealand, Spain, United Kingdom

Regulatory

• FDA-regulated drug study