NCT06006858

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,284

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

18 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

Study Start

First participant enrolled

November 3, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

August 22, 2023

Last Update Submit

November 16, 2023

Conditions

COVID-19

Keywords

COVID-19Moderna VaccineSafety Vaccine

Outcome Measures

Primary Outcomes (2)

  • Local Reactions Following Moderna COVID-19 Vaccine

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

    28 Days after each dose

  • Systemic Reactions Following Moderna COVID-19 Vaccine

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

    28 Days after each dose

Secondary Outcomes (5)

  • Immediate Reactions

    30 minutes after each dose

  • 1-3 Days Reactions

    1-3 minutes after each dose

  • 4-7 Days Reactions

    4-7 Days after each dose

  • 8-28 Days Reactions

    8-28 Days after each dose

  • Serious Reactions

    28 Days after each dose

Study Arms (1)

Moderna COVID-19 Vaccine

Clinically healthy adults aged ≥ 18 years who received Primary Moderna COVID-19 Vaccine

Biological: Moderna COVID-19 Vaccine

Interventions

Moderna COVID-19 VaccineBIOLOGICAL

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.

Moderna COVID-19 Vaccine

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Gambir Public Health Center

Jakarta Pusat, Jakarta Special Capital Region, 10130, Indonesia

Location

Johar Baru Public Health Center

Jakarta Pusat, Jakarta Special Capital Region, 10560, Indonesia

Location

Cempaka Putih Public Health Center

Jakarta Pusat, Jakarta Special Capital Region, 10570, Indonesia

Location

Kemayoran Public Health Center

Jakarta Pusat, Jakarta Special Capital Region, 10640, Indonesia

Location

Palmerah Public Health Center

Jakarta, 11480, Indonesia

Location

Kebon Jeruk Public Health Center

Jakarta, 11530, Indonesia

Location

Cengkareng Public Health Center

Jakarta, 11730, Indonesia

Location

Kebayoran Lama Public Health Center

Jakarta, 12240, Indonesia

Location

Tebet Public Health Center

Jakarta, 12820, Indonesia

Location

Setiabudi Public Health Center

Jakarta, 12980, Indonesia

Location

Pulo Gadung Public Health Center

Jakarta, 13260, Indonesia

Location

Duren Sawit Public Health Center

Jakarta, 13420, Indonesia

Location

Regional Hospital Duren Sawit

Jakarta, 13440, Indonesia

Location

Kramat Jati Public Health Center

Jakarta, 13510, Indonesia

Location

Cilincing Public Health Center

Jakarta, 14120, Indonesia

Location

Koja Public Health Center

Jakarta, 14260, Indonesia

Location

Tanjung Priok Public Health Center

Jakarta, 14310, Indonesia

Location

Pademangan Public Health Center

Jakarta, 14410, Indonesia

Location

MeSH Terms

Conditions

COVID-19

Interventions

2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA VaccinesNucleic Acid-Based VaccinesVaccines, SyntheticRecombinant ProteinsProteinsAmino Acids, Peptides, and ProteinsVaccinesBiological ProductsComplex MixturesCOVID-19 VaccinesViral VaccinesAntigensBiological Factors

Study Officials

  • Julitasari Sundoro, MD

    National Advisory Immunization Committee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2023

First Posted

August 23, 2023

Study Start

November 3, 2022

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

ID(18)