Safety Profile Following Inactivated COVID-19 Vaccine in... | NCT05037227

Studies
Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia

NCT05037227

Sponsor

PT Bio Farma

Status

Completed

Last Update Posted

Jul 27, 2022Actual

Enrollment

1,100Actual

Phase

Not provided

Conditions

Safety Issues

Interventions

Not provided

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2, 2021Actual

Primary Completion Date

Oct 17, 2021Actual

Completion Date

Dec 27, 2021Actual

First Submitted Date

Sep 6, 2021

First Submission Date that Met QC Criteria

Sep 6, 2021

First Posted Date

Sep 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2022

Last Update Posted Date

Jul 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is evaluating safety profile of COVID-19 Vaccine in healthy adults aged >18 years in Indonesia.

Detailed Description

To assess any serious systemic reaction within 30 minutes after COVID-19 vaccine immunization.

To assess systemic reaction after COVID-19 Vaccine immunization. To assess local reaction after COVID-19 Vaccine immunization. To assess any serious adverse event after COVID-19 Vaccine immunization.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Any serious adverse event occurring from inclusion until 30 minutes after the injection	Number and percentage of subjects with serious systemic reactions 30 minutes after immunization.	Within 30 minutes after vaccination

Secondary Outcomes

Measure	Description	Time Frame
Local reaction and systemic events occurring within 30 minutes after each immunization.	Number and percentage of subjects with at least one of these adverse events, solicited or not, within 30 minutes after vaccination.	Within 30 minutes after vaccination
Local reaction and systemic events occurring within 28 days after immunization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinically healthy adults aged > 18 years.
Subjects have been informed properly regarding the study and signed the informed consent form.
Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with thermometer).
Women who are lactating, pregnant or planning to become pregnant during the study period.
History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)).
Subjects receive any vaccination within 1 month before and after IP immunization.
Subjects plan to move from the study area before the end of study period.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study is involving healthy adults aged > 18 years.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julitasari Sundoro, MD	Indonesian Vaccine Safety Advisory Commitee	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jakarta Provincial Ministry of Health		Jakarta	DKI Jakarta		Indonesia