N/A
Completed N=25
Special Investigation for Booster Dose of Comirnaty in Children Ages 6 Months Though 4 Years
Source: ClinicalTrials.gov NCT06130410 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: Proportion of Participants With Adverse Reaction (AR) — 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Adverse Reaction (AR) |
1 | — |
| PRIMARY Proportion of Participants With Serious Adverse Reaction (SAR) |
— | — |
| PRIMARY Proportion of Participants With Reactogenicity (≥ Grade 1) in Those Who Are Younger Than 2 Years of Age |
5; 4 | — |
| PRIMARY Proportion of Participants With Reactogenicity (≥ Grade 1) in Those Who Are Aged 2 Years or Older |
7; 2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT06130410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.