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Completed

NCT Number: NCT06690502

Post Authorization Safety Profile of Booster IndoVac COVID-19 Vaccination

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gambir Public Health Center, Jakarta, Center Jakarta, Indonesia

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About this study

This study is Post Authorization Safety Study (PASS) Phase IV, to assess any local and systemic reaction after immunization with IndoVac using retrospective cohort study trial design to assess safety profile following IndoVac booster vaccine in healthy populations aged 18 years and above.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Serious adverse event following IndoVac booster vaccination

    Time frame: until 30 minutes after each dose

    Any serious adverse event occurring from inclusion until 30 minutes after IndoVac booster vaccination

Secondary outcomes

  1. 0-7 Days Reactions

    Time frame: Within 0-7 Days after each dose

    Number and percentage of any solicited and unsolicited local reaction and systemic events within 0-7 days after IndoVac booster vaccination.

  2. 8-28 Days Reactions

    Time frame: Within 8-28 Days after each dose

    Number and percentage of any solicited and unsolicited local reaction and systemic events within 8-28 days after IndoVac booster vaccination.

  3. 28 Days Reactions

    Time frame: 28 Days after each dose

    Number and percentage of any serious adverse event after IndoVac booster vaccination

Sponsors and collaborators

Lead sponsor

PT Bio Farma

Industry

Registry information

Official study title

Safety Profile of Booster IndoVac COVID-19 Vaccination in Healthy Populations Aged 18 Years and Above

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 15, 2024
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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