Drug Use Investigation of COMIRNATY Intramuscular Injection

An observational study of COVID-19, run by Pfizer at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Post-marketing study, Chotor study of COMIRNATY vaccenees followed for 11months. Serious adverse events and COVID-19 observed during the follow-up period will be collected, and the long-term safety of this product will be assessed. Read more about this study

Who is it for?: Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: BNT162b2
Type of treatment: Vaccines, Injection or infusion
How many people: 14,570 participants
Where: 1 siteJapan
Study dates: 20 Mar 2021to 27 Jan 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: All subjects who have been vaccinated with this product and have consented to participate in this study during participation in the Investigation of Health Status of Recipients Vaccinated First at contract sites.

Who may be able to join

Subjects who have participated in the Investigation of Health Status of Recipients Vaccinated First and have provided written consent to continue participation in this study.

Who cannot join

No exclusion criteria.

Trial locations and contacts

1 site in 1 country.

Japan1 site

PfizerLocal Country Office
Tokyo, 1518589

Other trials in Japan

About this study

Official title: General Investigation of COMIRNATY Intramuscular Injection (Follow-up Study for Subjects [Healthcare Professionals] Who Are Vaccinated at an Early Post-Approval Stage)

Read the detailed description

The healthcare professionals who are vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) will be followed for 11 months from the day following 28 days after the final vaccination of the initial immunization with this product (end date of observation period in Investigation of Health Status of Recipients Vaccinated First) to 12 months after the final vaccination of the initial immunization with this product, information on serious adverse events and COVID-19 observed during the follow-up period will be collected.

If booster vaccination isn't conducted, the long-term safety after the initial immunization of this product during the follow-up period will be assessed.

If booster vaccination is conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination will be confirmed, and information on serious adverse events and COVID-19 will be continuously obtained after booster vaccination.

Conditions: COVID-19
Being tested: BNT162b2
Keywords: COVID-19, Post-Marketing study, COMIRNATY,Vaccine
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BNT162b2Biological
Also called COMIRNATY
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. Individuals 16 years of age and older.

Study groups in NCT04815031
Study group	Role	What they receive
COMIRNATY		COVID-19 mRNA vaccine (nucleoside-modified) Receives: Biological: BNT162b2

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Participants With Serious Adverse Events
A serious adverse event was any untoward medical occurrence 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.
Measured: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
Proportion of Participants With Severe COVID-19
By using the information on COVID-19 entered in the CRF submitted by the physician, participants who were considered to be in a severe condition were identified and the number and proportion of the participants were tabulated with reference to the severity classification in the Guidance for Treatment of Novel Coronavirus Infection (COVID-19).
Participants with severe COVID-19 were defined as any of the following actions taken during the period from disease onset to the outcome date: admission to an ICU; use of mechanical ventilation; or use of ECMO.
Measured: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
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.
Measured: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
Number of Participants With Serious Adverse Events After Booster Vaccination
A serious adverse event was any untoward medical occurrence 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.
Measured: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)
Number of Participants With Severe COVID-19 After Booster Vaccination
By using the information on COVID-19 entered in the CRF submitted by the physician, participants who were considered to be in a severe condition were identified and the number and proportion of the participants were tabulated with reference to the severity classification in the Guidance for Treatment of Novel Coronavirus Infection (COVID-19).
Participants with severe COVID-19 were defined as any of the following actions taken during the period from disease onset to the outcome date: admission to an ICU; use of mechanical ventilation; or use of ECMO.
Measured: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)
Number of Participants With Serious Adverse Reactions After Booster Vaccination
A serious adverse reaction was any untoward medical occurrence attributed to the vaccines received as a booster vaccination 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.
Measured: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 202127 Jan 2023

First posted24 Mar 2021
Study start20 Mar 2021
Primary completion27 Jan 2023
Study completion27 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 14,570 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04815031
Sponsor's protocol ID: C4591006
Status last verified: Oct 2024
First submitted: 22 Mar 2021
Last updated: 27 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: General Investigation of COMIRNATY Intramuscular Injection (Follow-up Study for Subjects [Healthcare Professionals] Who Are Vaccinated at an Early Post-Approval Stage)
ClinicalTrials.gov ID: NCT04815031
Acronym / sponsor ID: C4591006
Conditions: COVID-19
Keywords: COVID-19, Post-Marketing study, COMIRNATY,Vaccine
Study type: Observational
Recruitment status: Completed
Enrolment: 14,570 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 20 Mar 2021 (actual)
Primary completion: 27 Jan 2023 (actual)
Study completion: 27 Jan 2023 (actual)
First posted: 24 Mar 2021 (actual)
Results: Posted 30 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

If booster vaccination isn't conducted, the long-term safety after the initial immunization of this product during the follow-up period will be assessed.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
COMIRNATY	–	Biological: BNT162b2COVID-19 mRNA vaccine (nucleoside-modified)

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: All subjects who have been vaccinated with this product and have consented to participate in this study during participation in the Investigation of Health Status of Recipients Vaccinated First at contract sites.

Key inclusion criteria (1 listed)

Subjects who have participated in the Investigation of Health Status of Recipients Vaccinated First and have provided written consent to continue participation in this study.

Key exclusion criteria (1 listed)

No exclusion criteria.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BNT162b2Also: COMIRNATYComirnaty 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. Individuals 16 years of age and older.	Biological	COMIRNATY

Primary outcome

Proportion of Participants With Serious Adverse Events
Time frame: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
A serious adverse event was any untoward medical occurrence 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.
Proportion of Participants With Severe COVID-19
Time frame: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
By using the information on COVID-19 entered in the CRF submitted by the physician, participants who were considered to be in a severe condition were identified and the number and proportion of the participants were tabulated with reference to the severity classification in the Guidance for Treatment of Novel Coronavirus Infection (COVID-19). Participants with severe COVID-19 were defined as any of the following actions taken during the period from disease onset to the outcome date: admission to an ICU; use of mechanical ventilation; or use of ECMO.
Proportion of Participants With Serious Adverse Reactions
Time frame: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
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.
Number of Participants With Serious Adverse Events After Booster Vaccination
Time frame: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)
A serious adverse event was any untoward medical occurrence 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.
Number of Participants With Severe COVID-19 After Booster Vaccination
Time frame: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)
By using the information on COVID-19 entered in the CRF submitted by the physician, participants who were considered to be in a severe condition were identified and the number and proportion of the participants were tabulated with reference to the severity classification in the Guidance for Treatment of Novel Coronavirus Infection (COVID-19). Participants with severe COVID-19 were defined as any of the following actions taken during the period from disease onset to the outcome date: admission to an ICU; use of mechanical ventilation; or use of ECMO.
Number of Participants With Serious Adverse Reactions After Booster Vaccination
Time frame: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)
A serious adverse reaction was any untoward medical occurrence attributed to the vaccines received as a booster vaccination 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.

Results and safety

Results posted to the registry on 30 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
COMIRNATY Intramuscular Injection	14,570	14,537

Primary outcome: Proportion of Participants With Serious Adverse Events

Time frame: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.. Number. Unit: Percentage of Participants

Measure	COMIRNATY (Tozinameran) ; If the Booster Vaccination Was Conducted, up to the Day Before Booster n = 14537
Value	0.83

Population analysed: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once. Participants with no adverse event information (missing information) were excluded.

Primary outcome: Proportion of Participants With Severe COVID-19

Measure	COMIRNATY (Tozinameran) ; If the Booster Vaccination Was Conducted, up to the Day Before Booster n = 14537
Value	0

Primary outcome: Proportion of Participants With Serious Adverse Reactions

Measure	COMIRNATY (Tozinameran) ; If the Booster Vaccination Was Conducted, up to the Day Before Booster n = 14537
Value	0.03

Primary outcome: Number of Participants With Serious Adverse Events After Booster Vaccination

Time frame: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation). Number. Unit: Participants

Measure	COMIRNATY (Tozinameran) ; If the Booster Vaccination Was Conducted, After the Booster n = 13695
Value	48

Population analysed: Participants who received booster vaccination regardless of COMIRNATY or other COVID-19 vaccines

Adverse events

Time frame: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
COMIRNATY (Tozinameran) (1) If the Booster Vaccination Was Conducted, up to the Day Before Booster.	120 of 14,537 (0.8%)	0 of 0	1 of 14,537
COMIRNATY (Tozinameran) (2) If the Booster Vaccination Was Conducted, After the Booster.	48 of 13,695 (0.4%)	0 of 0	0 of 13,695

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Pfizer at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants With Serious Adverse Events (time frame: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04815031.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.