Special Investigation of COMIRNATY in the Population With Underlying Diseases

NCT04880447 | Completed Results

• 1 other identifier: C4591019
• Study Type: observational
• Target: 1,075
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19,; Post-Marketing study; COMIRNATY; Underlying Disease

Outcome Measures

Primary Outcomes (4)

• 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.

  From the date of the first dose to 28 days after the second dose, up to approximately 49 days.

• 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.

  From the date of the first dose to 28 days after the second dose, up to approximately 49 days.

• 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.

  Within 8 days after the date of the first dose.

• 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.

  Within 8 days after the date of the second dose.

Study Arms (1)

COMIRNATY

COVID-19 mRNA vaccine

Biological: BNT162b2

Interventions

BNT162b2 BIOLOGICAL

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.

Also known as: COMIRNATY

COMIRNATY

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with underlying disease considered to be at high risk of aggravation of COVID-19 (Underlying diseases considered to be at high risk of aggravation of COVID-19 are based on the range of patients with underlying diseases indicated by the Ministry of Health, Labour and Welfare for priority vaccination.)

You may qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Local County

Tokyo, 1518589, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 10, 2021
• Study Start: May 26, 2021
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: June 21, 2024
• Results First Posted: June 21, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)