RECRUITINGOBSERVATIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- Participant whose participation is deemed inappropriate at the investigator's discretion.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Treatments Being Tested
BIOLOGICAL
SPIKEVAX Bivalent
No study drug will be administered during this study as this is an observational study.
BIOLOGICAL
SPIKEVAX X
No study drug will be administered during this study as this is an observational study.
Locations (20)
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
Sinsegie ENT Clinic
Busan, South Korea
Jeil Family Medicine Clinic
Gwangju, 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