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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05630352
Recruitment Status : Not yet recruiting
First Posted : November 29, 2022
Last Update Posted : February 23, 2023
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
BioNTech SE

Brief 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.


Condition or disease Intervention/treatment Phase
COVID-19 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 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Phase 1 open label sequential dose escalation study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A MASTER PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BIVALENT BNT162b2 RNA-BASED VACCINE CANDIDATE(S) IN HEALTHY INFANTS AND CHILDREN
Estimated Study Start Date : January 31, 2024
Estimated Primary Completion Date : May 16, 2025
Estimated Study Completion Date : May 16, 2025


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




Primary Outcome Measures :
  1. Substudy A - Percentage of participants reporting local reactions in each dose level [ Time Frame: For 7 days following Dose 1, Dose 2, Dose 3 ]
    Tenderness at the injection site, redness, and swelling as self-reported on electronic diaries.

  2. Substudy A - Percentage of participants reporting systemic events in each dose level [ Time Frame: For 7 days following Dose 1, Dose 2 and Dose 3 ]
    Fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries.

  3. Substudy A - Percentage of participants reporting adverse events in each dose level [ Time Frame: Dose 1 through 1 month after Dose 3 ]
    As elicited by investigational site staff

  4. Substudy A - Percentage of participants reporting serious adverse events in each dose level [ Time Frame: Dose 1 through 6 months after Dose 3 ]
    As elicited by investigational site staff


Secondary Outcome Measures :
  1. Substudy A - Geometric mean titers elicited by prophylactic bivalent BNT162b2 at each dose level in COVID-19 vaccine-naïve participants < 6 months of age [ Time Frame: At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3 ]
    As measured at the central laboratory

  2. 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 [ Time Frame: At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3 ]
    As measured at the central laboratory

  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 [ Time Frame: At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3 ]
    As measured at the central laboratory



Information from the National Library of Medicine

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Ages Eligible for Study:   72 Days to 102 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05630352


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Sponsors and Collaborators
BioNTech SE
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: BioNTech SE
ClinicalTrials.gov Identifier: NCT05630352    
Other Study ID Numbers: C4591023
First Posted: November 29, 2022    Key Record Dates
Last Update Posted: February 23, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by BioNTech SE:
SARS-CoV-2 infection
COVID-19
SARS-CoV-2 Virus
Severe Acute Respiratory Syndrome Coronavirus 2
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases