COVID-19
Conditions
Keywords
COVID-19,, Post-Marketing study, COMIRNATY, Underlying Disease
Brief summary
Post-marketing study, Cohort study of COMIRNATY vaccines. To collect information on adverse events and COVID-19 observed after vaccination with COMIRNATY and to assess safety in patients with underlying disease considered to be at high risk of aggravation of COVID-19 who have received vaccination with this product under actual use conditions.
Detailed description
This is a multicenter cohort study to be conducted in individuals with underlying diseases considered to be at high risk of aggravation of COVID-19 who are vaccinated with this product, and the investigator will enter the information required in this study in the case report forms (CRFs) based on the information obtained through preliminary examination sheet or medical interview, etc. and records such as medical records. A health observation diary will be distributed to the subjects participating in this study and they will be requested to record information on local reactions and systemic reactions after vaccination with this product.
Interventions
BIOLOGICALBNT162b2
COMIRNATY is administered intramuscularly after dilution as a course of 2 doses (0.3 mL each). It is recommended to administer the second dose 3 weeks after the first dose.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
-Subjects who are able to understand the content of this study and to record their symptoms in the health observation diary, and who have provided written consent to participate in this survey by themselves (or parents or legal guardians in the case of minors)
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Adverse Reactions | From the date of the first dose to 28 days after the second dose, up to approximately 49 days. | An adverse reaction was any untoward medical occurrence attributed to COMIRNATY in a participant who was vaccinated with COMIRNATY. Relatedness to COMIRNATY was assessed by the physician. The proportion of adverse reactions was presented for the overall observation period, the observation period from the date of the first dose of Comirnaty up to 28 days after the second dose, and the observation period from the date of Dose 1 up to 28 days after Dose 2. |
| Proportion of Participants With Serious Adverse Reactions | From the date of the first dose to 28 days after the second dose, up to approximately 49 days. | A serious adverse reaction was any untoward medical occurrence attributed to COMIRNATY resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. Relatedness to COMIRNATY was assessed by the physician. The proportion of serious adverse reactions was presented for the overall observation period, the observation period from the first to the second vaccination, and the observation period from the date of Dose 1 up to 28 days after Dose 2. |
| Proportion of Participants With Local Reactions and Systemic Reactions (The First Vaccination) | Within 8 days after the date of the first dose. | Local and systemic reactions were treated as specific adverse events of interest in this study, and were reported using the health observation diary filled out by the participants. Severity was rated and recorded as grade 1, 2, or 3 according to the FDA Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Health observation diary for the first vaccination was collected from 1035 participants of the 1038 safety analysis set participants. |
| Proportion of Participants With Local Reactions and Systemic Reactions (The Second Vaccination) | Within 8 days after the date of the second dose. | Local and systemic reactions were treated as specific adverse events of interest in this study, and were reported using the health observation diary filled out by the participants. Severity was rated and recorded as grade 1, 2, or 3 according to the FDA Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Health observation diary for the second vaccination was collected from 1026 participants of the 1032 participants who received the second vaccination with Comirnaty. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| COMIRNATY Intramuscular Injection (Tozinameran) Participants with underlying disease considered to be at high risk of aggravation of COVID-19, who were vaccinated with Comirnaty as indicated in the approved local product document were observed from the date of Dose 1 to 28 days after Dose 2. | 1,038 |
| Total | 1,038 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Disease not covered in this study | 35 |
| Overall Study | No adverse event information (missing information) | 1 |
| Overall Study | No vaccination information | 1 |
Baseline characteristics
| Characteristic | COMIRNATY Intramuscular Injection (Tozinameran) | — |
|---|---|---|
| Age, Customized ≥15 and <65 years | 568 Participants | — |
| Age, Customized <15 years | 3 Participants | — |
| Age, Customized ≥65 years | 467 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 433 Participants | — |
| Sex: Female, Male Male | 605 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 1,038 |
| other Total, other adverse events | 114 / 1,038 |
| serious Total, serious adverse events | 11 / 1,038 |
Outcome results
Primary
Proportion of Participants With Adverse Reactions
An adverse reaction was any untoward medical occurrence attributed to COMIRNATY in a participant who was vaccinated with COMIRNATY. Relatedness to COMIRNATY was assessed by the physician. The proportion of adverse reactions was presented for the overall observation period, the observation period from the date of the first dose of Comirnaty up to 28 days after the second dose, and the observation period from the date of Dose 1 up to 28 days after Dose 2.
Time frame: From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| COMIRNATY Intramuscular Injection (Tozinameran) | Proportion of Participants With Adverse Reactions | Overall observation period | 59 Participants |
| COMIRNATY Intramuscular Injection (Tozinameran) | Proportion of Participants With Adverse Reactions | Observation from the 1st to the 2nd vaccination | 30 Participants |
| COMIRNATY Intramuscular Injection (Tozinameran) | Proportion of Participants With Adverse Reactions | Observation from 2nd vaccination to 28 days | 39 Participants |
Primary
Proportion of Participants With Local Reactions and Systemic Reactions (The First Vaccination)
Local and systemic reactions were treated as specific adverse events of interest in this study, and were reported using the health observation diary filled out by the participants. Severity was rated and recorded as grade 1, 2, or 3 according to the FDA Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Health observation diary for the first vaccination was collected from 1035 participants of the 1038 safety analysis set participants.
Time frame: Within 8 days after the date of the first dose.
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| COMIRNATY Intramuscular Injection (Tozinameran) | Proportion of Participants With Local Reactions and Systemic Reactions (The First Vaccination) | Local reactions | 836 Participants |
| COMIRNATY Intramuscular Injection (Tozinameran) | Proportion of Participants With Local Reactions and Systemic Reactions (The First Vaccination) | Systemic reactions | 648 Participants |
Primary
Proportion of Participants With Local Reactions and Systemic Reactions (The Second Vaccination)
Local and systemic reactions were treated as specific adverse events of interest in this study, and were reported using the health observation diary filled out by the participants. Severity was rated and recorded as grade 1, 2, or 3 according to the FDA Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Health observation diary for the second vaccination was collected from 1026 participants of the 1032 participants who received the second vaccination with Comirnaty.
Time frame: Within 8 days after the date of the second dose.
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| COMIRNATY Intramuscular Injection (Tozinameran) | Proportion of Participants With Local Reactions and Systemic Reactions (The Second Vaccination) | Local reactions | 866 Participants |
| COMIRNATY Intramuscular Injection (Tozinameran) | Proportion of Participants With Local Reactions and Systemic Reactions (The Second Vaccination) | Systemic reactions | 716 Participants |
Primary
Proportion of Participants With Serious Adverse Reactions
A serious adverse reaction was any untoward medical occurrence attributed to COMIRNATY resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. Relatedness to COMIRNATY was assessed by the physician. The proportion of serious adverse reactions was presented for the overall observation period, the observation period from the first to the second vaccination, and the observation period from the date of Dose 1 up to 28 days after Dose 2.
Time frame: From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| COMIRNATY Intramuscular Injection (Tozinameran) | Proportion of Participants With Serious Adverse Reactions | Overall observation period | 3 Participants |
| COMIRNATY Intramuscular Injection (Tozinameran) | Proportion of Participants With Serious Adverse Reactions | Observation from the 1st to the 2nd vaccination | 1 Participants |
| COMIRNATY Intramuscular Injection (Tozinameran) | Proportion of Participants With Serious Adverse Reactions | Observation from 2nd vaccination to 28 days | 2 Participants |