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
Brief Summary
The purpose of this post-marketing study is to assess the safety of Comirnaty monovalentXBB.1.5. for booster vaccination children ages 6 months though 4 years under actual usemedical practice.
Detailed Description
Not Provided
Completed
SARS-CoV-2
COVID-19
Biological: COMIRNATY intramuscular injection
Booster injection in the muscle, 1 dose
Eligibility Criteria
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.
Eligibility Gender
All
Eligibility Age
Minimum: 6 Months ~ Maximum: 4 Years
Countries
Japan
Locations
Pfizer Local Country
Tokyo 1850147, Japan
Pfizer CT.gov Call Center, Study Director
Pfizer
Pfizer
NCT Number
Keywords
Covid-19
SARS-CoV-2
Children (6 months though 4 years old)
RNA Vaccine
Post-Marketing Study
Pediatric
MeSH Terms
COVID-19