NCT04904549

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

A Parallel-group, Phase III, Multi-stage, Modified Double-blind, Multi-armed Study to Assess the Efficacy, Safety, and Immunogenicity of Two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (Monovalent and Bivalent) for Prevention Against COVID-19 in Adults 18 Years of Age and Older as a Primary Series and Open-label Extension to Assess Immunogenicity, Safety, Efficacy of a Monovalent Booster Dose of SARS-CoV2 Adjuvanted Recombinant Protein Vaccine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23,726 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The duration of participation in the initial, double-blind, primary series design of the study will be approximately 365 days post-last injection (ie, approximately 386 days total) for each participant. Based on decisions of the Study OG, 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

• COVID-19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-08-20
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2021-05-27
• Last updated: 2024-10-16

Locations

86 sites across 11 countries: United States, Colombia, Ghana, Honduras, India, Japan, Kenya, Mexico, Nepal, Uganda, Ukraine

Regulatory

• FDA-regulated drug study