Brief Summary

This study is Post Authorization Safety Study (PASS) Phase IV of Booster IndoVac COVID-19 Vaccination

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,208

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach

1 country

28 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

Study Start

First participant enrolled

December 18, 2023

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2024

Completed

4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2024

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2024

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed

Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 13, 2024

Last Update Submit

November 13, 2024

Conditions

COVID-19

Keywords

COVID-19IndoVacSafety Vaccine

Outcome Measures

Primary Outcomes (1)

Serious adverse event following IndoVac booster vaccination
Any serious adverse event occurring from inclusion until 30 minutes after IndoVac booster vaccination
until 30 minutes after each dose

Secondary Outcomes (3)

0-7 Days Reactions
Within 0-7 Days after each dose
8-28 Days Reactions
Within 8-28 Days after each dose
28 Days Reactions
28 Days after each dose

Study Arms (1)

IndoVac COVID-19 Vaccine

Clinically healthy adults aged 18 years and above who received Booster IndoVac COVID-19 Vaccination

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Healthy adults aged 18 years and above

You may qualify if:

Clinically healthy subjects aged 18 years and above
Subjects have been injected with IndoVac booster.
Minimum 6-month interval from primary or booster COVID-19 vaccination.
Subjects have been informed properly regarding the study and signed the informed consent form.

You may not qualify if:

Subjects concomitantly enrolled or scheduled to be enrolled in another study when the subjects got IndoVac booster vaccination.
Subject's telephone number is invalid or cannot be contacted.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

PT Bio Farmalead

Study Sites (28)

Gambir Public Health Center

Jakarta, Center Jakarta, Indonesia

Location

Kemayoran Public Health Center

Jakarta, Center Jakarta, Indonesia

Location

Menteng Public Health Center

Jakarta, Center Jakarta, Indonesia

Location

Sawah Besar Public Health Center

Jakarta, Center Jakarta, Indonesia

Location

Tanah Abang Public Health Center

Jakarta, Center Jakarta, Indonesia

Location

Cakung Public Health Center