MedTrace Logo

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

NCT04713553 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1574

Last updated 2022-12-22

Study results available
· View outcomes & findings →

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

Interventions

BIOLOGICAL

BNT162b2

Intramuscular injection

BIOLOGICAL

BNT162b2.B.1.351

Intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2021-07-22
Completion
2021-07-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04713553 on ClinicalTrials.gov