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

Completed

• Conditions: COVID-19; SARS-CoV-2
• Interventions: Biological: COMIRNATY intramuscular injection

• Registration Number: NCT06130410
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-14
• Study Start: 2024-03-06
• Primary Completion: 2024-07-26
• Study Completion: 2024-07-26
• Status Verified: 2025-06
• Results First Submitted: 2025-06-25
• Results First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Results First Posted: 2025-07-14
• Last Update Posted: 2025-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Serious Adverse Reaction (SAR)	For 28 days after the booster (4th) dose	An SAR was defined as any AR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/malfunction; congenital anomaly/birth defect; or other medically important events.
Proportion of Participants With Adverse Reaction (AR)	For 28 days after the booster (4th) dose	An adverse event was defined as any untoward medical occurrence attributed to COMIRNATY intramuscular injection for 6 months to 4 years old (monovalent: Omicron XBB.1.5) in a participant who was vaccinated. The relatedness was assessed by the physician. Events for which a causal relationship with intramuscular injection could not be ruled out were handled as ARs.
Proportion of Participants With Reactogenicity (≥ Grade 1) in Those Who Are Younger Than 2 Years of Age	Within 7 days after the date of the booster (4th) dose	Local reactions and systemic events recorded in the health observation diary collected by the physician from study participants were handled as reactogenicity events.; They were aggregated for the vaccinated participants by age group and grade. The results were aggregated by age group for local reactions and systemic events of grade 1 or higher.; If the participants were younger than 2 years of age on the date of the booster (4th) dose, the following reactogenicity events were aggregated. Local reactions: injection site tenderness, redness, and injection site swelling. Systemic events: pyrexia, decreased appetite, somnolence, and irritability. If the participants were 2 years or older on the date of the booster (4th) dose, the following reactogenicity events were aggregated. Local reactions: injection site pain, redness, and injection site swelling. Systemic events: pyrexia, vomiting, diarrhoea, headache, malaise, chills, myalgia, and arthralgia.
Proportion of Participants With Reactogenicity (≥ Grade 1) in Those Who Are Aged 2 Years or Older	Within 7 days after the date of the booster (4th) dose	Local reactions and systemic events recorded in the health observation diary collected by the physician from study participants were handled as reactogenicity events.; They were aggregated for the vaccinated participants by age group and grade. The results were aggregated by age group for local reactions and systemic events of grade 1 or higher.; If the participants were younger than 2 years of age on the date of the booster (4th) dose, the following reactogenicity events were aggregated. Local reactions: injection site tenderness, redness, and injection site swelling. Systemic events: pyrexia, decreased appetite, somnolence, and irritability. If the participants were 2 years or older on the date of the booster (4th) dose, the following reactogenicity events were aggregated. Local reactions: injection site pain, redness, and injection site swelling. Systemic events: pyrexia, vomiting, diarrhoea, headache, malaise, chills, myalgia, and arthralgia.

Trial Locations

Locations (1)

Pfizer Local Country; 🇯🇵 Tokyo, Japan