Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection.
- Registration Number
- NCT06333704
- Lead Sponsor
- ModernaTX, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4206
- 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.
- Participant whose participation is deemed inappropriate at the investigator's discretion.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SPIKEVAX BIVALENT or SPIKEVAX X SPIKEVAX Bivalent Participants receiving at least 1 dose of SPIKEVAX BIVALENT vaccine or SPIKEVAX X Injection are monitored for safety parameters up to 28 days post vaccination. SPIKEVAX BIVALENT or SPIKEVAX X SPIKEVAX X Participants receiving at least 1 dose of SPIKEVAX BIVALENT vaccine or SPIKEVAX X Injection are monitored for safety parameters up to 28 days post vaccination.
- Primary Outcome Measures
Name Time Method Number of Participants With AEs Up to 28 days post vaccination
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Sinsegie ENT Clinic
🇰🇷Busan, Korea, Republic of
Kium Children Hospital
🇰🇷Gunsan, Jeollabuk-do, Korea, Republic of
Jeil Family Medicine Clinic
🇰🇷Gwangju, Korea, Republic of
Yonsei Kids Pediatrics Clinic
🇰🇷Seoul, Korea, Republic of
Seoul Bon Clinic
🇰🇷Seoul, Korea, Republic of
GF Pediatrics Clinic
🇰🇷Seoul, Korea, Republic of
Joon Pediatric Clinic
🇰🇷Gwangmyeong, Gyeonggi-do, Korea, Republic of
Hanyang Union Rehabilitation Medicine Clinic
🇰🇷Yangju, Gyeonggi-do, Korea, Republic of
KimHyungjoo Clinic
🇰🇷Yangju, Gyeonggi-do, Korea, Republic of
Woori Medical Clinic
🇰🇷Seoul, Korea, Republic of
Nalee Hospital
🇰🇷Gimpo, Gyeonggi-do, Korea, Republic of
Janghyeon Medicine Clinic
🇰🇷Siheung, Gyeonggi-do, Korea, Republic of
Star Pediatrics Clinic
🇰🇷Seoul, Korea, Republic of
Ma Hak ki Family Medicine Clinic
🇰🇷Bucheon, Gyeonggi-do, Korea, Republic of
Yonseimin Clinic
🇰🇷Wonju, Gangwon-do, Korea, Republic of
Hyundai Clinic
🇰🇷Bucheon, Gyeonggi-do, Korea, Republic of
COA ENT Clinic
🇰🇷Goyang, Gyeonggi-do, Korea, Republic of
Bupyeong Yonsei Medical Clinic
🇰🇷Incheon, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Dr Cho's Family Medical Clinic
🇰🇷Seoul, Korea, Republic of
Songpa Korea Neurosurgical Clinic
🇰🇷Seoul, Korea, Republic of
New Yonsei ENT Clinic
🇰🇷Seoul, Korea, Republic of
Kim Il Joong Internal Medicine Clinic
🇰🇷Seoul, Korea, Republic of
Soo Orthopedics Clinic
🇰🇷Seoul, Korea, Republic of