Special Investigation for Booster Dose of Comirnaty in Children Ages 6 Months Though 4 Years
Sponsor
Pfizer (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06130410
Collaborator
(none)
66
1
9.6
6.9
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
66 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Special Investigation for Booster Dose of Comirnaty (ｍonovalent: Omicron XBB.1.5.) Intramuscular Injection in Children of the 6 Months Though 4 Years of Age.
Anticipated Study Start Date
:
Dec 8, 2023
Anticipated Primary Completion Date
:
Sep 24, 2024
Anticipated Study Completion Date
:
Sep 24, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| COMIRNATY intramuscular injection for 6 months to 4 years old (monovalent, omicron XBB.1.5.)
|
Biological: COMIRNATY intramuscular injection
Booster injection in the muscle, 1 dose
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants with adverse reaction [For 28 days after the booster dose]
- Percentage of participants with serious adverse reaction [For 28 days after the booster dose]
- Percentage of participants with reactogenicity events. [For 7 days following the booster dose]
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Months
to 4 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Local Country | Tokyo | Japan | 1518589 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT06130410
Other Study ID Numbers:
- C4591057
First Posted:
Nov 14, 2023
Last Update Posted:
Nov 14, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pfizer
Additional relevant MeSH terms: