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Thousands monitored for vaccine side effects in korean safety study

NCT ID NCT06333704

Knowledge-focused Sponsor: ModernaTX, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracks over 4,200 people in South Korea who received a SPIKEVAX COVID-19 vaccine to see if any side effects occur over time. Participants are aged 12 or older depending on the vaccine version. The goal is to gather real-world safety data, not to test if the vaccine works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

4,207 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease viral infectious disease COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SARS-CoV-2

Contacts and locations

Locations

  • Bupyeong Yonsei Medical Clinic

    Incheon, 21405, South Korea

  • COA ENT Clinic

    Goyang-si, Gyeonggi-do, 10234, South Korea

  • Dr Cho's Family Medical Clinic

    Seoul, 05351, South Korea

  • GF Pediatrics Clinic

    Seoul, 06568, South Korea

  • Gangseo HANA ENT

    Seoul, 07774, South Korea

  • Hanyang Union Rehabilitation Medicine Clinic

    Yangju, Gyeonggi-do, 11404, South Korea

  • Hyundai Clinic

    Bucheon-si, Gyeonggi-do, 14483, South Korea

  • Inha University Hospital

    Incheon, 22332, South Korea

  • Janghyeon Medicine Clinic

    Namyangju, Gyeonggi-do, 14998, South Korea

  • Jeong's Family Medical Clinic

    Siheung, Gyeonggi-do, 15065, South Korea

  • Joon Pediatric Clinic

    Gwangmyeong, Gyeonggi-do, 14250, South Korea

  • Kim Il Joong Internal Medicine Clinic

    Seoul, 06727, South Korea

  • Kim's Pediatrics Clinic

    Seoul, 08652, South Korea

  • KimHyungjoo Clinic

    Yangju, Gyeonggi-do, 11456, South Korea

  • Kium Children Hospital

    Gunsan, Jeollabuk-do, 54072, South Korea

  • Ma Hak ki Family Medicine Clinic

    Bucheon-si, Gyeonggi-do, 14614, South Korea

  • Nalee Hospital

    Gimpo-si, Gyeonggi-do, 10108, South Korea

  • New Yonsei ENT Clinic

    Seoul, 07327, South Korea

  • Seoul Bon Clinic

    Seoul, 04032, South Korea

  • Sinsegie ENT Clinic

    Busan, 48111, South Korea

  • Songpa Korea Neurosurgical Clinic

    Seoul, 05769, South Korea

  • Soo Orthopedics Clinic

    Seoul, 08701, South Korea

  • Star Pediatrics Clinic

    Seoul, 03912, South Korea

  • Woori Medical Clinic

    Seoul, 01684, South Korea

  • Yonsei Kids Pediatrics Clinic

    Seoul, 01851, South Korea

  • Yonseimin Clinic

    Wŏnju, Gangwon-do, 26428, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.