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A Study to Learn About Bivalent COVID-19 RNA Vaccine Candidate(s) in Healthy Infants and Children

NCT05630352 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-03-18

No results posted yet for this study

Summary

The purpose of this clinical trial is to learn about the safety and immune responses of the study vaccine (called a bivalent BNT162b2 Omicron containing vaccine) in healthy infants and children. Sub study A of this clinical trial will test up to four different dose levels of the vaccine in infants who are under 6 months of age and have not previously received a coronavirus vaccination.

This will be a 3- dose primary series of the study vaccine with each dose separated by 8 weeks.

Conditions

Interventions

BIOLOGICAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose

Injection in the muscle

BIOLOGICAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose

Injection in the muscle

BIOLOGICAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose

Injection in the muscle

BIOLOGICAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 1 microgram dose

Injection in the muscle

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
72 Days
Max Age
102 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-06
Primary Completion
2026-07-13
Completion
2026-07-13
FDA Drug
Yes

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Entities

Diseases
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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 NCT05630352 on ClinicalTrials.gov