COVID-19, SARS-CoV-2
Conditions
Keywords
COVID-19, SARS-CoV-2, Children (6 months though 4 years old), RNA Vaccine, Post-Marketing Study, Pediatric
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.
Interventions
BIOLOGICALCOMIRNATY intramuscular injection
Booster injection in the muscle, 1 dose
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 4 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
Countries
Japan
Participant flow
Pre-assignment details
The enrollment period ended with 25 participants completed.
Participants by arm
| Arm | Count |
|---|---|
| COMIRNATY Intramuscular Injection for 6 Months to 4 Years Old (Monovalent: Omicron XBB.1.5) 3μg Participants aged 6 months to 4 years old were vaccinated with the booster (4th) dose of COMIRNATY intramuscular injection for 6 months to 4 years old (monovalent: Omicron XBB.1.5) on Day 1. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | COMIRNATY Intramuscular Injection for 6 Months to 4 Years Old (Monovalent: Omicron XBB.1.5) 3μg | — |
|---|---|---|
| Age, Customized ≥2 and ≤4 years | 10 participants | — |
| Age, Customized ≥6 months and <2 years | 15 participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Sex Female | 13 Participants | — |
| Sex: Female, Male Sex Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 5 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
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
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY intramuscular injection for 6 months to 4 years old (monovalent: Omicron XBB.1.5) at least once. Among the 25 participants with fixed CRFs in the study, no participants were excluded from the safety analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COMIRNATY Intramuscular Injection for 6 Months to 4 Years Old (Monovalent: Omicron XBB.1.5) 3μg | Proportion of Participants With Adverse Reaction (AR) | 1 Participants |
Primary
Proportion of Participants With Reactogenicity (≥ Grade 1) in Those Who Are Aged 2 Years or Older
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
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY intramuscular injection for 6 months to 4 years old (monovalent: Omicron XBB.1.5) at least once. Among the 25 participants with fixed CRFs in the study, no participants were excluded from the safety analysis set. Of the safety analysis set, participants aged 2 years or older were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| COMIRNATY Intramuscular Injection for 6 Months to 4 Years Old (Monovalent: Omicron XBB.1.5) 3μg | Proportion of Participants With Reactogenicity (≥ Grade 1) in Those Who Are Aged 2 Years or Older | Local reactions (Grade 1 or higher) | 7 Participants |
| COMIRNATY Intramuscular Injection for 6 Months to 4 Years Old (Monovalent: Omicron XBB.1.5) 3μg | Proportion of Participants With Reactogenicity (≥ Grade 1) in Those Who Are Aged 2 Years or Older | Systemic events (Grade 1 or higher) | 2 Participants |
Primary
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
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY intramuscular injection for 6 months to 4 years old (monovalent: Omicron XBB.1.5) at least once. Among the 25 participants with fixed CRFs in the study, no participants were excluded from the safety analysis set. Of the safety analysis set, participants younger than 2 years were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| COMIRNATY Intramuscular Injection for 6 Months to 4 Years Old (Monovalent: Omicron XBB.1.5) 3μg | Proportion of Participants With Reactogenicity (≥ Grade 1) in Those Who Are Younger Than 2 Years of Age | Local reactions (Grade 1 or higher) | 5 Participants |
| COMIRNATY Intramuscular Injection for 6 Months to 4 Years Old (Monovalent: Omicron XBB.1.5) 3μg | Proportion of Participants With Reactogenicity (≥ Grade 1) in Those Who Are Younger Than 2 Years of Age | Systemic events (Grade 1 or higher) | 4 Participants |
Primary
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
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY intramuscular injection for 6 months to 4 years old (monovalent: Omicron XBB.1.5) at least once. Among the 25 participants with fixed CRFs in the study, no participants were excluded from the safety analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COMIRNATY Intramuscular Injection for 6 Months to 4 Years Old (Monovalent: Omicron XBB.1.5) 3μg | Proportion of Participants With Serious Adverse Reaction (SAR) | 0 Participants |