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

Recruiting in Palo Alto (17 mi)

+16 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: BioNTech SE

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Inclusion Criteria

Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Primary study: Male or female participants between the ages of 12 and 50 years, inclusive, at randomization.

Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

Treatment Details

Interventions

• BNT162b2 (Virus Therapy)
• BNT162b2.B.1.351 (Virus Therapy)

Participant Groups

Group I: Booster 2: BNT162b2.B.1.351 Experimental Treatment 1 Intervention

30-microgram dose

Group II: Booster 1: BNT162b2 Experimental Treatment 1 Intervention

30-microgram dose

Group III: Arm 5 Experimental Treatment 1 Intervention

20-microgram dose of US manufactured drug substance (corresponding to Arm 1, 2 or 3 lot)

Group IV: Arm 4 Experimental Treatment 1 Intervention

30-microgram dose of EU manufactured drug substance (Lot 4)

Group V: Arm 3 Experimental Treatment 1 Intervention

30-microgram dose of US manufactured drug substance (Lot 3)

Group VI: Arm 2 Experimental Treatment 1 Intervention

30-microgram dose of US manufactured drug substance (Lot 2)

Group VII: Arm 1 Experimental Treatment 1 Intervention

30-microgram dose of US manufactured drug substance (Lot 1)

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University