Special Investigation for Booster Dose of Comirnaty in Children Ages 6 Months Though 4 Years

April 8, 2024 updated by: Pfizer

COMIRNATY Intramuscular Injection for 6 Months to 4 Years Old (Monovalent: Omicron XBB.1.5) Special Investigation for Booster Immunization in Children Aged 6 Months to 4 Years

The purpose of this post-marketing study is to assess the safety of Comirnaty monovalent XBB.1.5. for booster vaccination children ages 6 months though 4 years under actual use medical practice.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Tokyo, Japan, 1518589
        • Pfizer Local Country

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Children of 6 months though 4years of age, at the time of booster vaccination(4th dose)

Description

Inclusion Criteria:

  • Children aged 6 months to 4 years at the time of the booster vaccination (4th dose) who (or whose representative) gave written consent to take part in the study.

Exclusion Criteria:

-There are no exclusion criteria for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COMIRNATY intramuscular injection for 6 months to 4 years old (monovalent, omicron XBB.1.5.)
Biological: COMIRNATY intramuscular injection
Booster injection in the muscle, 1 dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with adverse reaction
Time Frame: For 28 days after the booster dose
For 28 days after the booster dose
Percentage of participants with serious adverse reaction
Time Frame: For 28 days after the booster dose
For 28 days after the booster dose
Percentage of participants with reactogenicity events.
Time Frame: For 7 days following the booster dose
For 7 days following the booster dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2024

Primary Completion (Estimated)

September 12, 2024

Study Completion (Estimated)

September 12, 2024

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C4591057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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