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SARS-CoV-2NCT06333704

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

An observational study of SARS-CoV-2, run by ModernaTX, Inc. at 26 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2
What is being tested?
SPIKEVAX Bivalent BA.1, SPIKEVAX Bivalent BA.4/5 and SPIKEVAX XBB.1.5
How many people
4,207 participants
Where
26 sitesSouth Korea
Study dates
10 Mar 2023to 29 Mar 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Participant whose participation is deemed inappropriate at the investigator's discretion.
  • Note: Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

South Korea26 sites

  • Hyundai Clinic

    Bucheon-si, Gyeonggi-do, 14483

  • Ma Hak ki Family Medicine Clinic

    Bucheon-si, Gyeonggi-do, 14614

  • Sinsegie ENT Clinic

    Busan, 48111

  • Nalee Hospital

    Gimpo-si, Gyeonggi-do, 10108

  • COA ENT Clinic

    Goyang-si, Gyeonggi-do, 10234

  • Kium Children Hospital

    Gunsan, Jeollabuk-do, 54072

  • Joon Pediatric Clinic

    Gwangmyeong, Gyeonggi-do, 14250

  • Bupyeong Yonsei Medical Clinic

    Incheon, 21405

  • Inha University Hospital

    Incheon, 22332

  • Janghyeon Medicine Clinic

    Namyangju, Gyeonggi-do, 14998

  • Woori Medical Clinic

    Seoul, 01684

  • Yonsei Kids Pediatrics Clinic

    Seoul, 01851

  • Star Pediatrics Clinic

    Seoul, 03912

  • Seoul Bon Clinic

    Seoul, 04032

  • Dr Cho's Family Medical Clinic

    Seoul, 05351

  • Songpa Korea Neurosurgical Clinic

    Seoul, 05769

  • GF Pediatrics Clinic

    Seoul, 06568

  • Kim Il Joong Internal Medicine Clinic

    Seoul, 06727

  • New Yonsei ENT Clinic

    Seoul, 07327

  • Gangseo HANA ENT

    Seoul, 07774

  • Kim's Pediatrics Clinic

    Seoul, 08652

  • Soo Orthopedics Clinic

    Seoul, 08701

  • Jeong's Family Medical Clinic

    Siheung, Gyeonggi-do, 15065

  • Yonseimin Clinic

    Wŏnju, Gangwon-do, 26428

  • Hanyang Union Rehabilitation Medicine Clinic

    Yangju, Gyeonggi-do, 11404

  • KimHyungjoo Clinic

    Yangju, Gyeonggi-do, 11456

Other trials in South Korea

About this study

Official title: 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.

Conditions
SARS-CoV-2
Being tested
SPIKEVAX Bivalent BA.1, SPIKEVAX Bivalent BA.4/5, SPIKEVAX XBB.1.5, SPIKEVAX JN.1
Keywords
mRNA-1273, mRNA-1273 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna
Medical subject headings
Coronavirus Infections, Virus Diseases, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPIKEVAX Bivalent BA.1Biological

    Also called MODERNA SPIKEVAX BIVALENT (Elasomeran, Imelasomeran), SPIKEVAX BIVALENT (Elasomeran, Imelasomeran)

    No study drug will be administered during this study as this is an observational study.

  • SPIKEVAX Bivalent BA.4/5Biological

    Also called SPIKEVAX BIVALENT (Elasomeran, Davesomeran), SPIKEVAX BIVALENT INJECTION DUO (Elasomeran, Davesomeran)

    No study drug will be administered during this study as this is an observational study.

  • SPIKEVAX XBB.1.5Biological

    Also called SPIKEVAX X Injection

    No study drug will be administered during this study as this is an observational study.

  • SPIKEVAX JN.1Biological

    Also called SPIKEVAX JN Injection, SPIKEVAX in Pre-filled Syringe

    No study drug will be administered during this study as this is an observational study.

Study groups in NCT06333704
Study groupRoleWhat they receive
SPIKEVAX BIVALENT, SPIKEVAX X, SPIKEVAX JN, or SPIKEVAX IN PRE-FILLED SYRINGEParticipants 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.
Receives: Biological: SPIKEVAX Bivalent BA.1; Biological: SPIKEVAX Bivalent BA.4/5; Biological: SPIKEVAX XBB.1.5; Biological: SPIKEVAX JN.1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With AEs

    Measured: Up to 28 days post vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2024
  2. Study start10 Mar 2023
  3. Primary completion29 Mar 2029 (estimated)
  4. Study completion29 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06333704
Sponsor's protocol ID
mRNA-1273-P924
Status last verified
Apr 2026
First submitted
20 Mar 2024
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV-2, run by ModernaTX, Inc. at 26 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With AEs (time frame: Up to 28 days post vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06333704.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.

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