Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT, SPIKEVAX X Injection, SPIKEVAX JN Injection and SPIKEVAX IN PRE-FILLED SYRINGE
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
1 other identifier
observational
4,207
1 country
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2023
Longer than P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2023
CompletedFirst Submitted
Initial submission to the registry
March 20, 2024
CompletedFirst Posted
Study publicly available on registry
March 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 29, 2029
April 16, 2026
April 1, 2026
6.1 years
March 20, 2024
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With AEs
Up to 28 days post vaccination
Study Arms (1)
SPIKEVAX BIVALENT, SPIKEVAX X, SPIKEVAX JN, or SPIKEVAX IN PRE-FILLED SYRINGE
Participants 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.
Interventions
No study drug will be administered during this study as this is an observational study.
No study drug will be administered during this study as this is an observational study.
No study drug will be administered during this study as this is an observational study.
No study drug will be administered during this study as this is an observational study.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Participant whose participation is deemed inappropriate at the investigator's discretion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
- C&R Research, Inc.collaborator
Study Sites (26)
Yonseimin Clinic
Wŏnju, Gangwon-do, 26428, South Korea
Hyundai Clinic
Bucheon-si, Gyeonggi-do, 14483, South Korea
Ma Hak ki Family Medicine Clinic
Bucheon-si, Gyeonggi-do, 14614, South Korea
Nalee Hospital
Gimpo-si, Gyeonggi-do, 10108, South Korea
COA ENT Clinic
Goyang-si, Gyeonggi-do, 10234, South Korea
Joon Pediatric Clinic
Gwangmyeong, Gyeonggi-do, 14250, South Korea
Janghyeon Medicine Clinic
Namyangju, Gyeonggi-do, 14998, South Korea
Jeong's Family Medical Clinic
Siheung, Gyeonggi-do, 15065, South Korea
Hanyang Union Rehabilitation Medicine Clinic
Yangju, Gyeonggi-do, 11404, South Korea
KimHyungjoo Clinic
Yangju, Gyeonggi-do, 11456, South Korea
Kium Children Hospital
Gunsan, Jeollabuk-do, 54072, South Korea
Sinsegie ENT Clinic
Busan, 48111, South Korea
Bupyeong Yonsei Medical Clinic
Incheon, 21405, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Woori Medical Clinic
Seoul, 01684, South Korea
Yonsei Kids Pediatrics Clinic
Seoul, 01851, South Korea
Star Pediatrics Clinic
Seoul, 03912, South Korea
Seoul Bon Clinic
Seoul, 04032, South Korea
Dr Cho's Family Medical Clinic
Seoul, 05351, South Korea
Songpa Korea Neurosurgical Clinic
Seoul, 05769, South Korea
GF Pediatrics Clinic
Seoul, 06568, South Korea
Kim Il Joong Internal Medicine Clinic
Seoul, 06727, South Korea
New Yonsei ENT Clinic
Seoul, 07327, South Korea
Gangseo HANA ENT
Seoul, 07774, South Korea
Kim's Pediatrics Clinic
Seoul, 08652, South Korea
Soo Orthopedics Clinic
Seoul, 08701, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2024
First Posted
March 27, 2024
Study Start
March 10, 2023
Primary Completion (Estimated)
March 29, 2029
Study Completion (Estimated)
March 29, 2029
Last Updated
April 16, 2026
Record last verified: 2026-04