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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMIRNATY intramuscular injection for 6 months to 4 years old (monovalent, omicron XBB.1.5.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COMIRNATY intramuscular injection | Biological | Booster injection in the muscle, 1 dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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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Inclusion Criteria:
Exclusion Criteria:
-There are no exclusion criteria for this study.
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Children of 6 months though 4years of age, at the time of booster vaccination(4th dose)
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Local Country | Tokyo | 1518589 | Japan |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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The enrollment period ended with 25 participants completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 25 participants were enrolled in this study. Of the 25 participants from whom case report forms (CRFs) were collected, no participants were excluded from the safety analysis set.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | For 28 days after the booster (4th) dose |
|
For 28 days after the booster (4th) dose
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA/J27.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 27, 2023 | Jun 25, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2025 | Jun 25, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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 |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
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. |
|
|
| 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. | 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. | Posted | Count of Participants | Participants | For 28 days after the booster (4th) dose |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Within 7 days after the date of the booster (4th) dose |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Within 7 days after the date of the booster (4th) dose |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 5 |
| 25 |
| Nasopharyngitis | Infections and infestations | MedDRA/J27.0 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA/J27.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |