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

Pfizer

Status: Completed

Conditions: COVID-19; SARS-CoV-2

Treatments: Biological: COMIRNATY intramuscular injection

Study type: Observational

Funder types: Industry

Identifiers

NCT06130410

C4591057

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 6 months to 4 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

25 participants in 1 patient group

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

Treatment:

Biological: COMIRNATY intramuscular injection