At a glance
ClinicalIndex Comparison RecordN/ACompleted· 25 enrolled
Drug / intervention
COMIRNATY intramuscular injectionbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
An observational study evaluating COMIRNATY intramuscular injection for SARS-CoV-2 and COVID-19. Completed, enrolled 25 participants across 1 site.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV-2, COVID-19
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
202420252026
First PostedNov 2023
Enrollment StartMar 2024
Primary CompletionJul 2024
TodayJul 2026
First PostedNov 14, 2023
Enrollment StartMar 6, 2024
Primary CompletionJul 26, 2024
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 2.6 years ago
Interventions
COMIRNATY intramuscular injectionbiological
Booster injection in the muscle, 1 dose