NCT04816669

A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults

A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE FORMULATIONS OF THE VACCINE CANDIDATE BNT162B2 AGAINST COVID 19 IN HEALTHY ADULTS 18 THROUGH 55 YEARS OF AGE

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 629 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will compare the safety and tolerability of lyophilized BNT162b2 presented in single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine whether the immune response is noninferior. Separately, the study will also describe the safety and immunogenicity of frozen-liquid BNT162b2 with lipid nanoparticle size at the upper end of specification and ready to use BNT162b2 (the immediate manufacturing precursor to the lyophilate). Additionally, the study will describe the safety and immunogenicity of an additional dose of frozen liquid BNT162b2 to participants who already received the 2-dose schedule of lyophilized BNT162b2. * 2-dose schedule (separated by 21 days) * At a dose of 30µg (as studied in the Phase 2/3 study C4591001) * In healthy adults 18 through 55 years of age * The duration of the study for each participant will be approximately 2 months (3 visits in total) * The study will be conducted in the United States

Conditions

• SARS-CoV-2 Infection
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	BNT162b2	Intramuscular injection

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-12-01
• Completion: 2021-12-02
• First posted: 2021-03-25
• Last updated: 2022-12-23
• Results posted: 2022-12-23

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study