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Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection. | Clinical Trials | Clareo Health

RECRUITING

Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection.

A Multi-Centre, Prospective, Observational Post-Marketing Surveillance to Investigate the Long-Term Safety of SPIKEVAX BIVALENT and SPIKEVAX X Injection Under Routine Clinical Care in Korea

NCT06333704•ModernaTX, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participants should be 18 years or older for Spikevax bivalent BA.1, SPIKEVAX BIVALENT BA.4/5 vaccine, and 12 years or older for Spikevax XBB.1.5 injection.
•Participants of any age which is approved for the use of SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5 or SPIKEVAX XBB.1.5 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 or SPIKEVAX XBB.1.5 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 or SPIKEVAX XBB.1.5.

Exclusion Criteria

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

Locations (24)

Yonseimin Clinic

Wŏnju, Gangwon-do, South Korea

Hyundai Clinic

Bucheon-si, Gyeonggi-do, South Korea

Ma Hak ki Family Medicine Clinic

Bucheon-si, Gyeonggi-do, South Korea

Nalee Hospital

Gimpo-si, Gyeonggi-do, South Korea

COA ENT Clinic

Goyang-si, Gyeonggi-do, South Korea

Joon Pediatric Clinic

Gwangmyeong, Gyeonggi-do, South Korea

Janghyeon Medicine Clinic

Siheung, Gyeonggi-do, South Korea

Hanyang Union Rehabilitation Medicine Clinic

Yangju, Gyeonggi-do, South Korea

KimHyungjoo Clinic

Yangju, Gyeonggi-do, South Korea

Kium Children Hospital

Gunsan, Jeollabuk-do, South Korea

Key Dates

Start Date

March 10, 2023

Primary Completion Date

December 10, 2028

Completion Date

December 10, 2028

Last Updated

March 19, 2025

Enrollment

4,206

ESTIMATED participants

Conditions

SARS-CoV-2

Interventions

SPIKEVAX Bivalent

BIOLOGICAL

SPIKEVAX X

BIOLOGICAL

Contacts

Moderna WeCare Team

CONTACT

1-866-663-3762 WeCareClinicalTrials@modernatx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection.

Inclusion Criteria

Exclusion Criteria

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