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Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT, SPIKEVAX X Injection, SPIKEVAX JN Injection and SPIKEVAX IN PRE-FILLED SYRINGE
Sponsor: ModernaTX, Inc.
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.
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
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
OBSERVATIONAL
Enrollment
4207
Start Date
2023-03-10
Completion Date
2029-03-29
Last Updated
2026-04-16
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (26)
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
Namyangju, Gyeonggi-do, South Korea
Jeong's Family Medical 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
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