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Completed

NCT Number: NCT06006858

Post Authorization Safety Study Moderna COVID-19 Primary Vaccine

This study is Post Authorization Safety Study (PASS) Phase IV of Moderna COVID-19 Primary Vaccine

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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

Cempaka Putih Public Health Center, Jakarta Pusat, Jakarta Special Capital Region, 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 Moderna COVID-19 vaccine using retrospective cohort study trial design to assess safety profile following Moderna COVID-19 primary vaccine in healthy adults aged ≥ 18 years in Indonesia.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Clinically healthy adults aged ≥ 18 years.
  • Subjects have been informed properly regarding the study and accepted to be enrolled in this study.

Exclusion criteria

  • Subjects concomitantly enrolled or scheduled to be enrolled in another trial at the time of receiving the Moderna COVID-19 vaccine.

Treatment and study plan

Moderna COVID-19 Vaccine

Biological

Moderna COVID-19 Vaccine is provided as a white to off-white suspension for intramuscular injection. Each 0.5 mL dose of Moderna COVID-19 Vaccine contains 100 mcg of nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 virus.

Primary outcomes

  1. Local Reactions Following Moderna COVID-19 Vaccine

    Time frame: 28 Days after each dose

    Percentage of subject with local reactions following immunization with Moderna COVID-19 vaccine.

  2. Systemic Reactions Following Moderna COVID-19 Vaccine

    Time frame: 28 Days after each dose

    Percentage of subject with systemic reactions following immunization with Moderna COVID-19

Secondary outcomes

  1. Immediate Reactions

    Time frame: 30 minutes after each dose

    percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.

  2. 1-3 Days Reactions

    Time frame: 1-3 minutes after each dose

    percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.

  3. 4-7 Days Reactions

    Time frame: 4-7 Days after each dose

    percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.

  4. 8-28 Days Reactions

    Time frame: 8-28 Days after each dose

    percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.

  5. Serious Reactions

    Time frame: 28 Days after each dose

    Any serious adverse events following immunization with Moderna COVID-19 vaccine

Sponsors and collaborators

Lead sponsor

PT Bio Farma

Industry

Collaborators

  • National Advisory Immunization Committee Indonesia

Registry information

Official study title

Safety Profile Following Moderna COVID-19 Primary Vaccine in Healthy Adults Aged ≥ 18 Years in Indonesia

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 23, 2023
Registry last updated
Nov 18, 2023

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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