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A Study to Understand is the COVID-19 Vaccine BNT162b2 is Safe in Indonesia People

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05621239
Recruitment Status : Active, not recruiting
First Posted : November 17, 2022
Last Update Posted : June 5, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:

The purpose of this study is to characterize descriptively the BNT162b2 vaccination safety experience among the Indonesian people. We will look at adverse events (AEs) reported in Indonesia Vaccine Safety Website for people 12 years of age and older. AEs are unwanted reactions associated with the use of the BNT162b2 vaccine. They may or may not be caused by this vaccine.

The secondary data collection will be exclusively from the Indonesia Vaccine Safety Website as requested by BPOM. This study does not seek additional participants. We will look at reported AEs for BNT162b2 vaccine since it became available in Indonesia. Individual data will be de-identified first before use. This will help protect personal information.

We will study the AEs associated with the BNT162b2 vaccine in several ways. These include the type of AEs and which body parts affected, among others. This will help us understand it the vaccine is safe in Indonesian people.


Condition or disease Intervention/treatment
COVID-19 Biological: BNT162b2

Study Design
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Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Safety Profile of BNT162b2 mRNA SARS-Cov-2 Vaccine in Indonesia: A National Passive Surveillance.
Actual Study Start Date : March 15, 2023
Estimated Primary Completion Date : June 19, 2023
Estimated Study Completion Date : June 19, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
COMIRNATY
COVID-19 mRNA vaccine
 Biological: BNT162b2
BNT162b2 half dose and full dose


Outcome Measures
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Primary Outcome Measures :
  1. The proportion of participants reporting Serious Adverse Event (SAE) after primary vaccination as compared to booster dose [ Time Frame: 1 year ]
  2. Total number of Adverse Events (AE) reported after both primary and booster dose [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Onset of SAE less than or equal to 30 minutes [ Time Frame: 1 year ]
    Number of participants reporting SAE less than or equal to 30 minutes

  2. Onset of SAE more than 30 minutes [ Time Frame: 1 year ]
    Number of participants reporting SAE onset more than 30 minutes

  3. Participants categorized according to the World Health Organization (WHO) causality assessment of adverse events following immunization [ Time Frame: 1 year ]
    WHO causality assessment of adverse event following immunization include (coincidence, Immunization Stress Related Response, vaccine reaction, unclassifiable, or indeterminate)

  4. Number of participants reporting local solicited AEs [ Time Frame: 1 year ]
    Local reaction include pain, swelling, redness or thickness

  5. Number of participants reporting systemic solicited AEs [ Time Frame: 1 year ]
    Systemic reaction include fever, myalgia, malaise

  6. Number of participants reporting local unsolicited reactions [ Time Frame: 1 year ]
    Local reactions includes abscess, bleeding, etc.

  7. Number of participants reporting systemic unsolicited reaction [ Time Frame: 1 year ]
    Systemic reaction include headache, nausea, arthralgia, etc.

  8. Proportion of participants reporting serious AEs as compared to non serious AEs [ Time Frame: 1 year ]
  9. Number of participants reporting solicited AE compared to unsolicited AE [ Time Frame: 1 year ]

Biospecimen Description:
Observational study for secondary data collection and analysis of structured data

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
people in Indonesia above 12 years of age who received vaccine and report an adverse event
Criteria

Inclusion Criteria:

This study will include adverse events reported in Indonesia Vaccine Safety Website for individuals 12 years of age and older

Exclusion Criteria:

None

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05621239


Locations
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Indonesia
Pfizer
Jakarta, Indonesia
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05621239    
Other Study ID Numbers: C4591050
First Posted: November 17, 2022    Key Record Dates
Last Update Posted: June 5, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pfizer:
Indonesia
Vaccine
BNT162b2
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases