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 Type
OBSERVATIONAL
Enrollment
25
Booster injection in the muscle, 1 dose
Pfizer Local Country
Tokyo, Japan
Proportion of Participants With Adverse Reaction (AR)
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.
Time frame: For 28 days after the booster (4th) dose
Proportion of Participants With Serious Adverse Reaction (SAR)
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.
Time frame: For 28 days after the booster (4th) dose
Proportion of Participants With Reactogenicity (≥ Grade 1) in Those Who Are Younger Than 2 Years of Age
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.
Time frame: Within 7 days after the date of the booster (4th) dose
Proportion of Participants With Reactogenicity (≥ Grade 1) in Those Who Are Aged 2 Years or Older
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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.
Time frame: Within 7 days after the date of the booster (4th) dose