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

Completed

• Conditions: COVID-19; SARS-CoV-2
• Interventions: Biological: COMIRNATY intramuscular injection

• Registration Number: NCT06130410
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-14
• Study Start: 2024-03-06
• Primary Completion: 2024-07-26
• Study Completion: 2024-07-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COMIRNATY intramuscular injection for 6 months to 4 years old (monovalent, omicron XBB.1.5.)	COMIRNATY intramuscular injection	-

Primary Outcome Measures

Name	Time	Method
Percentage of participants with reactogenicity events.	For 7 days following the booster dose
Percentage of participants with adverse reaction	For 28 days after the booster dose
Percentage of participants with serious adverse reaction	For 28 days after the booster dose

Trial Locations

Locations (1)

Pfizer Local Country; 🇯🇵 Tokyo, Japan