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NCT06130410 Clinical Trial

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

COVID-19 Clinical Trial

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06130410
Other study ID # C4591057
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 6, 2024
Est. completion date August 28, 2024

Study information
Verified date May 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 25
Est. completion date August 28, 2024
Est. primary completion date August 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 4 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• COMIRNATY intramuscular injection
Booster injection in the muscle, 1 dose

Locations
Country Name City State
Japan Pfizer Local Country Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of participants with adverse reaction For 28 days after the booster dose
Primary Percentage of participants with serious adverse reaction For 28 days after the booster dose
Primary Percentage of participants with reactogenicity events. For 7 days following the booster dose
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