AzTrials
AzTrials

COVID-19Phase 1NCT05630352

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

A Phase 1 study testing Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose and Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose in people with COVID-19, run by BioNTech SE.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 72 to 102 daysHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose and Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
6 Jan 2025to 13 Jul 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 72 to 102 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

About this study

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

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
COVID-19
Being tested
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
Keywords
SARS-CoV-2 infection, COVID-19, SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Injection in the muscle

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

    Injection in the muscle

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

    Injection in the muscle

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

    Injection in the muscle

Study groups in NCT05630352
Study groupRoleWhat they receive
Dose level 1ExperimentalInjection in the muscle at 0-, 8-, and 16-weeks.
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose
Dose level 2ExperimentalInjection in the muscle at 0-, 8-, and 16-weeks
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose
Dose level 3ExperimentalInfection in the muscle at 0-, 8- and 16- weeks
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
Dose level 4ExperimentalInjection in the muscle at 0-, 8- and 16- weeks
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 1 microgram dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: For 7 days following Dose 1, Dose 2, Dose 3

  2. Substudy A - Percentage of participants reporting systemic events in each dose level

    Fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries.

    Measured: For 7 days following Dose 1, Dose 2 and Dose 3

  3. Substudy A - Percentage of participants reporting adverse events in each dose level

    As elicited by investigational site staff

    Measured: Dose 1 through 1 month after Dose 3

  4. Substudy A - Percentage of participants reporting serious adverse events in each dose level

    As elicited by investigational site staff

    Measured: Dose 1 through 6 months after Dose 3

Secondary outcomes (3)

  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

    As measured at the central laboratory

    Measured: At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3

  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

    As measured at the central laboratory

    Measured: At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3

  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

    Measured: At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2022
  2. Study start6 Jan 2025 (estimated)
  3. Primary completion13 Jul 2026 (estimated)
  4. Study completion13 Jul 2026 (estimated)

Why it stopped: Bivalent vaccine no longer epidemiologically relevant.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Model description
Phase 1 open label sequential dose escalation study
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05630352
Sponsor's protocol ID
C4591023
Status last verified
Mar 2024
First submitted
22 Nov 2022
Last updated
18 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose and Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose in people with COVID-19, run by BioNTech SE.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Substudy A - Percentage of participants reporting local reactions in each dose level (time frame: For 7 days following Dose 1, Dose 2, Dose 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05630352.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.

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