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

Primary Purpose

COVID-19

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose
Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose
Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 1 microgram dose
Sponsored by
BioNTech SE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring SARS-CoV-2 infection, COVID-19, SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2

Eligibility Criteria

72 Days - 102 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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). Male or female participants born at greater than 32 weeks of gestation. Exclusion Criteria: Receipt of any nonstudy vaccine within 14 days, before study intervention administration (Dose 1 only). Receipt of medications intended to prevent COVID-19. Previous or current diagnosis of MIS-C (Multisystem Inflammatory Syndrome In Children). 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). Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 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. Previous vaccination with any non-study coronavirus vaccine. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids. 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. 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. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Dose level 1

    Dose level 2

    Dose level 3

    Dose level 4

    Arm Description

    Injection in the muscle at 0-, 8-, and 16-weeks.

    Injection in the muscle at 0-, 8-, and 16-weeks

    Infection in the muscle at 0-, 8- and 16- weeks

    Injection in the muscle at 0-, 8- and 16- weeks

    Outcomes

    Primary Outcome Measures

    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.
    Substudy A - Percentage of participants reporting systemic events in each dose level
    Fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries.
    Substudy A - Percentage of participants reporting adverse events in each dose level
    As elicited by investigational site staff
    Substudy A - Percentage of participants reporting serious adverse events in each dose level
    As elicited by investigational site staff

    Secondary Outcome Measures

    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
    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
    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

    Full Information

    First Posted
    November 22, 2022
    Last Updated
    February 22, 2023
    Sponsor
    BioNTech SE
    Collaborators
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05630352
    Brief Title
    A Study to Learn About Bivalent COVID-19 RNA Vaccine Candidate(s) in Healthy Infants and Children
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 31, 2024 (Anticipated)
    Primary Completion Date
    May 16, 2025 (Anticipated)
    Study Completion Date
    May 16, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    BioNTech SE
    Collaborators
    Pfizer

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19
    Keywords
    SARS-CoV-2 infection, COVID-19, SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Sequential Assignment
    Model Description
    Phase 1 open label sequential dose escalation study
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dose level 1
    Arm Type
    Experimental
    Arm Description
    Injection in the muscle at 0-, 8-, and 16-weeks.
    Arm Title
    Dose level 2
    Arm Type
    Experimental
    Arm Description
    Injection in the muscle at 0-, 8-, and 16-weeks
    Arm Title
    Dose level 3
    Arm Type
    Experimental
    Arm Description
    Infection in the muscle at 0-, 8- and 16- weeks
    Arm Title
    Dose level 4
    Arm Type
    Experimental
    Arm Description
    Injection in the muscle at 0-, 8- and 16- weeks
    Intervention Type
    Biological
    Intervention Name(s)
    Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose
    Intervention Description
    Injection in the muscle
    Intervention Type
    Biological
    Intervention Name(s)
    Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose
    Intervention Description
    Injection in the muscle
    Intervention Type
    Biological
    Intervention Name(s)
    Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
    Intervention Description
    Injection in the muscle
    Intervention Type
    Biological
    Intervention Name(s)
    Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 1 microgram dose
    Intervention Description
    Injection in the muscle
    Primary Outcome Measure Information:
    Title
    Substudy A - Percentage of participants reporting local reactions in each dose level
    Description
    Tenderness at the injection site, redness, and swelling as self-reported on electronic diaries.
    Time Frame
    For 7 days following Dose 1, Dose 2, Dose 3
    Title
    Substudy A - Percentage of participants reporting systemic events in each dose level
    Description
    Fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries.
    Time Frame
    For 7 days following Dose 1, Dose 2 and Dose 3
    Title
    Substudy A - Percentage of participants reporting adverse events in each dose level
    Description
    As elicited by investigational site staff
    Time Frame
    Dose 1 through 1 month after Dose 3
    Title
    Substudy A - Percentage of participants reporting serious adverse events in each dose level
    Description
    As elicited by investigational site staff
    Time Frame
    Dose 1 through 6 months after Dose 3
    Secondary Outcome Measure Information:
    Title
    Substudy A - Geometric mean titers elicited by prophylactic bivalent BNT162b2 at each dose level in COVID-19 vaccine-naïve participants < 6 months of age
    Description
    As measured at the central laboratory
    Time Frame
    At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3
    Title
    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
    Description
    As measured at the central laboratory
    Time Frame
    At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3
    Title
    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
    Description
    As measured at the central laboratory
    Time Frame
    At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    72 Days
    Maximum Age & Unit of Time
    102 Days
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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). Male or female participants born at greater than 32 weeks of gestation. Exclusion Criteria: Receipt of any nonstudy vaccine within 14 days, before study intervention administration (Dose 1 only). Receipt of medications intended to prevent COVID-19. Previous or current diagnosis of MIS-C (Multisystem Inflammatory Syndrome In Children). 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). Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 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. Previous vaccination with any non-study coronavirus vaccine. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids. 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. 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. 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pfizer CT.gov Call Center
    Phone
    1-800-718-1021
    Email
    ClinicalTrials.gov_Inquiries@pfizer.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://pmiform.com/clinical-trial-info-request?StudyID=C4591023
    Description
    To obtain contact information for a study center near you, click here.

    Learn more about this trial

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

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