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

A MASTER PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BIVALENT BNT162b2 RNA-BASED VACCINE CANDIDATE(S) IN HEALTHY INFANTS AND CHILDREN

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.

Study Overview

• Status: Withdrawn
• Conditions: COVID-19
• Intervention / Treatment: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose; Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose; Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose; Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 1 microgram dose

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 3 months (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male or female participants 72 through 102 days of age, at the time of randomization (the day of birth is considered Day 1 of life).
2. Male or female participants born at greater than 32 weeks of gestation.

Exclusion Criteria:

1. Receipt of any nonstudy vaccine within 14 days, before study intervention administration (Dose 1 only).
2. Receipt of medications intended to prevent COVID-19.
3. Previous or current diagnosis of MIS-C (Multisystem Inflammatory Syndrome In Children).
4. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s).
5. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
6. Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.
7. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
8. Other medical (e.g,. major known congenital malformation or serious chronic disorder such as seizures) or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Note: This includes both conditions that may increase the risk associated with study intervention administration or conditions that may interfere with the interpretation of study results.
9. Previous vaccination with any non-study coronavirus vaccine.
10. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids.
11. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies (except palivizumab and hepatitis B immunoglobulin), from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19 from 90 days before study intervention administration, or planned receipt throughout the study.
12. Receipt of other study intervention within 28 days prior to study entry through and including 28 days after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID-19, which are prohibited throughout study participation.
13. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members. Children or grandchildren who are direct descendants of investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose level 1; Injection in the muscle at 0-, 8-, and 16-weeks.	Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose; Injection in the muscle
Experimental: Dose level 2; Injection in the muscle at 0-, 8-, and 16-weeks	Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose; Injection in the muscle
Experimental: Dose level 3; Infection in the muscle at 0-, 8- and 16- weeks	Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose; Injection in the muscle
Experimental: Dose level 4; Injection in the muscle at 0-, 8- and 16- weeks	Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 1 microgram dose; Injection in the muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substudy A - Percentage of participants reporting local reactions in each dose level	Tenderness at the injection site, redness, and swelling as self-reported on electronic diaries.	For 7 days following Dose 1, Dose 2, Dose 3
Substudy A - Percentage of participants reporting systemic events in each dose level	Fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries.	For 7 days following Dose 1, Dose 2 and Dose 3
Substudy A - Percentage of participants reporting adverse events in each dose level	As elicited by investigational site staff	Dose 1 through 1 month after Dose 3
Substudy A - Percentage of participants reporting serious adverse events in each dose level	As elicited by investigational site staff	Dose 1 through 6 months after Dose 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substudy A - Geometric mean titers elicited by prophylactic bivalent BNT162b2 at each dose level in COVID-19 vaccine-naïve participants < 6 months of age	As measured at the central laboratory	At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3
Substudy A - Geometric mean fold rise elicited by prophylactic bivalent BNT162b2 at each dose level in COVID-19 vaccine-naïve participants < 6 months of age	As measured at the central laboratory	At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3
Substudy A - Percentage of participants with seroresponse elicited by prophylactic bivalent BNT162b2 at each dose level in COVID-19 vaccine-naïve participants < 6 months of age	As measured at the central laboratory	At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3

Collaborators and Investigators

• Sponsor: BioNTech SE
• Collaborators: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Estimated): January 6, 2025
• Primary Completion (Estimated): July 13, 2026
• Study Completion (Estimated): July 13, 2026

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; SARS-CoV-2 infection; Severe Acute Respiratory Syndrome Coronavirus 2; SARS-CoV-2 Virus
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: C4591023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No