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Clinical Trials in South Korea / NCT06333704
Active, not recruiting Observational

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

NCT06333704 · tracked via the Priya Life Science South Korea tracker
Sponsor
ModernaTX, Inc
Phase
Observational
Started
2023-03-10
Last updated
2026-04-16

Condition(s) studied

SARS-CoV-2

Investigational drug(s) / intervention(s)

SPIKEVAX Bivalent BA.1SPIKEVAX Bivalent BA.4/5SPIKEVAX XBB.1.5SPIKEVAX JN.1 →

SPIKEVAX Bivalent BA.1: No study drug will be administered during this study as this is an observational study.

SPIKEVAX Bivalent BA.4/5: No study drug will be administered during this study as this is an observational study.

SPIKEVAX XBB.1.5: No study drug will be administered during this study as this is an observational study.

SPIKEVAX JN.1: No study drug will be administered during this study as this is an observational study.

Study 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

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Number of Participants With AEs — Up to 28 days post vaccination

Trial sites (26)

FacilityCityRegionStatus
Yonseimin Clinic Wŏnju Gangwon-do
Hyundai Clinic Bucheon-si Gyeonggi-do
Ma Hak ki Family Medicine Clinic Bucheon-si Gyeonggi-do
Nalee Hospital Gimpo-si Gyeonggi-do
COA ENT Clinic Goyang-si Gyeonggi-do
Joon Pediatric Clinic Gwangmyeong Gyeonggi-do
Janghyeon Medicine Clinic Namyangju Gyeonggi-do
Jeong's Family Medical Clinic Siheung Gyeonggi-do
Hanyang Union Rehabilitation Medicine Clinic Yangju Gyeonggi-do
KimHyungjoo Clinic Yangju Gyeonggi-do
Kium Children Hospital Gunsan Jeollabuk-do
Sinsegie ENT Clinic Busan South Korea
Bupyeong Yonsei Medical Clinic Incheon South Korea
Inha University Hospital Incheon South Korea
Woori Medical Clinic Seoul South Korea
Yonsei Kids Pediatrics Clinic Seoul South Korea
Star Pediatrics Clinic Seoul South Korea
Seoul Bon Clinic Seoul South Korea
Dr Cho's Family Medical Clinic Seoul South Korea
Songpa Korea Neurosurgical Clinic Seoul South Korea
GF Pediatrics Clinic Seoul South Korea
Kim Il Joong Internal Medicine Clinic Seoul South Korea
New Yonsei ENT Clinic Seoul South Korea
Gangseo HANA ENT Seoul South Korea
Kim's Pediatrics Clinic Seoul South Korea
Soo Orthopedics Clinic Seoul South Korea

Other trials for the same condition

Korea Comirnaty Post-marketing Surveillance Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06333704 on ClinicalTrials.gov ↗ ← All trials in South Korea