Special Investigation for Booster Dose of Comirnaty in Children Ages 6 Months Though 4 Years
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Tokyo, Japan, 1518589
- Pfizer Local Country
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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COMIRNATY intramuscular injection for 6 months to 4 years old (monovalent, omicron XBB.1.5.)
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Booster injection in the muscle, 1 dose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Proportion of Participants With Adverse Reaction (AR)
Time Frame: For 28 days after the booster (4th) dose
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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.
|
For 28 days after the booster (4th) dose
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Proportion of Participants With Serious Adverse Reaction (SAR)
Time Frame: For 28 days after the booster (4th) dose
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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.
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For 28 days after the booster (4th) dose
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Proportion of Participants With Reactogenicity (≥ Grade 1) in Those Who Are Younger Than 2 Years of Age
Time Frame: Within 7 days after the date of the booster (4th) dose
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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. |
Within 7 days after the date of the booster (4th) dose
|
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Proportion of Participants With Reactogenicity (≥ Grade 1) in Those Who Are Aged 2 Years or Older
Time Frame: 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. |
Within 7 days after the date of the booster (4th) dose
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C4591057
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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