Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT, SPIKEVAX X Injection, SPIKEVAX JN Injection and SPIKEVAX IN PRE-FILLED SYRINGE

April 13, 2026 updated by: ModernaTX, Inc.

A Multi-centre, Prospective, Observational Post-marketing Surveillance to Investigate the Long-term Safety of SPIKEVAX BIVALENT, SPIKEVAX X Injection, SPIKEVAX JN Injection and SPIKEVAX IN PRE-FILLED SYRINGE Under Routine Clinical Care in Korea

The main objective of the surveillance is to evaluate the incidence of the adverse events (AEs), and other safety-related information in South-Korean population.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4207

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Busan, South Korea, 48111
        • Sinsegie ENT Clinic
      • Incheon, South Korea, 22332
        • Inha University Hospital
      • Incheon, South Korea, 21405
        • Bupyeong Yonsei Medical Clinic
      • Seoul, South Korea, 01684
        • Woori Medical Clinic
      • Seoul, South Korea, 01851
        • Yonsei Kids Pediatrics Clinic
      • Seoul, South Korea, 03912
        • Star Pediatrics Clinic
      • Seoul, South Korea, 04032
        • Seoul Bon Clinic
      • Seoul, South Korea, 05351
        • Dr Cho's Family Medical Clinic
      • Seoul, South Korea, 05769
        • Songpa Korea Neurosurgical Clinic
      • Seoul, South Korea, 06568
        • GF Pediatrics Clinic
      • Seoul, South Korea, 06727
        • Kim Il Joong Internal Medicine Clinic
      • Seoul, South Korea, 07327
        • New Yonsei ENT Clinic
      • Seoul, South Korea, 07774
        • Gangseo HANA ENT
      • Seoul, South Korea, 08652
        • Kim's Pediatrics Clinic
      • Seoul, South Korea, 08701
        • Soo Orthopedics Clinic
    • Gangwon-do
      • Wŏnju, Gangwon-do, South Korea, 26428
        • Yonseimin Clinic
    • Gyeonggi-do
      • Bucheon-si, Gyeonggi-do, South Korea, 14483
        • Hyundai Clinic
      • Bucheon-si, Gyeonggi-do, South Korea, 14614
        • Ma Hak ki Family Medicine Clinic
      • Gimpo-si, Gyeonggi-do, South Korea, 10108
        • Nalee Hospital
      • Goyang-si, Gyeonggi-do, South Korea, 10234
        • COA ENT Clinic
      • Gwangmyeong, Gyeonggi-do, South Korea, 14250
        • Joon Pediatric Clinic
      • Namyangju, Gyeonggi-do, South Korea, 14998
        • Janghyeon Medicine Clinic
      • Siheung, Gyeonggi-do, South Korea, 15065
        • Jeong's Family Medical Clinic
      • Yangju, Gyeonggi-do, South Korea, 11404
        • Hanyang Union Rehabilitation Medicine Clinic
      • Yangju, Gyeonggi-do, South Korea, 11456
        • KimHyungjoo Clinic
    • Jeollabuk-do
      • Gunsan, Jeollabuk-do, South Korea, 54072
        • Kium Children Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The population of this survey is Korean participants vaccinated with SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5, SPIKEVAX XBB.1.5, and SPIKEVAX JN.1 who meet the inclusion/exclusion criteria.

Description

Inclusion Criteria:

  • Participants should be 18 years or older for SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5, and 12 years or older for SPIKEVAX XBB.1.5 and SPIKEVAX JN.1.
  • Participants of any age which is approved for the use of SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5, SPIKEVAX XBB.1.5, or SPIKEVAX JN.1 for active immunization to prevent COVID-19 caused by SARS-CoV-2.
  • Participant who will be vaccinated with SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5, SPIKEVAX XBB.1.5, or SPIKEVAX JN.1 following local label approved by Ministry of Food and Drug Safety (MFDS).
  • Participant who will be vaccinated with at least one dose of SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5, SPIKEVAX XBB.1.5, or SPIKEVAX JN.1.

Exclusion Criteria:

  • Participant whose participation is deemed inappropriate at the investigator's discretion.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SPIKEVAX BIVALENT, SPIKEVAX X, SPIKEVAX JN, or SPIKEVAX IN PRE-FILLED SYRINGE
Participants receiving at least 1 dose of SPIKEVAX BIVALENT vaccine, SPIKEVAX X Injection, SPIKEVAX JN Injection, or SPIKEVAX in Pre-filled Syringe will be monitored for safety parameters up to 28 days post vaccination.
Biological: SPIKEVAX Bivalent BA.1
No study drug will be administered during this study as this is an observational study.
Other Names:
  • MODERNA SPIKEVAX BIVALENT (Elasomeran, Imelasomeran)
  • SPIKEVAX BIVALENT (Elasomeran, Imelasomeran)
Biological: SPIKEVAX Bivalent BA.4/5
No study drug will be administered during this study as this is an observational study.
Other Names:
  • SPIKEVAX BIVALENT (Elasomeran, Davesomeran)
  • SPIKEVAX BIVALENT INJECTION DUO (Elasomeran, Davesomeran)
Biological: SPIKEVAX XBB.1.5
No study drug will be administered during this study as this is an observational study.
Other Names:
  • SPIKEVAX X Injection
Biological: SPIKEVAX JN.1
No study drug will be administered during this study as this is an observational study.
Other Names:
  • SPIKEVAX JN Injection
  • SPIKEVAX in Pre-filled Syringe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With AEs
Time Frame: Up to 28 days post vaccination
Up to 28 days post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModernaTX, Inc.

Collaborators

C&R Research, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2023

Primary Completion (Estimated)

March 29, 2029

Study Completion (Estimated)

March 29, 2029

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mRNA-1273-P924

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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