NCT04713553

A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants

A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE PRODUCTION LOTS AND DOSE LEVELS OF THE VACCINE CANDIDATE BNT162b2 AGAINST COVID-19 IN HEALTHY PARTICIPANTS 12 THROUGH 50 YEARS OF AGE AND THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED COVID-19 VACCINE CANDIDATES AS A BOOSTER DOSE IN HEALTHY PARTICIPANTS 18 THROUGH 50 YEARS OF AGE

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,574 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 3, randomized, observer-blind study in healthy individuals. The primary study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate (BNT162b2): * As a 30-microgram dose, administered from 1 of 4 manufacturing lots (batches) * As a 20-microgram dose, administered from 1 of the manufacturing lots * As a 2-dose (separated by 21 days) schedule * In people 12 through 50 years of age The booster study will evaluate the safety, tolerability, and immunogenicity of 2 SARS-CoV-2 RNA vaccine candidates (BNT162b2 and BNT162b2.B.1.351): * Each as a 30-microgram dose * Each as a 1-dose booster vaccine, administered approximately 3 months after Dose 2 * In people 18 through 50 years of age

Conditions

• SARS-CoV-2 Infection
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	BNT162b2	Intramuscular injection
BIOLOGICAL	BNT162b2.B.1.351	Intramuscular injection

Timeline

• Start date: 2021-02-15
• Primary completion: 2021-07-22
• Completion: 2021-07-22
• First posted: 2021-01-19
• Last updated: 2022-12-22
• Results posted: 2022-12-22

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study