Monitoring safety of SPIKEVAX vaccines in South Korea
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
This study is checking for any side effects in people aged 12 and older who are getting the SPIKEVAX COVID-19 vaccines in South Korea to make sure they are safe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4206 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | ModernaTX, Inc. Industry-sponsored |
| Locations | 24 sites (Wonju, Gangwon-do and 23 other locations) |
| Trial ID | NCT06333704 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the incidence of adverse events and gather safety-related information regarding the SPIKEVAX Bivalent and SPIKEVAX X vaccines in the South Korean population. Participants aged 12 and older who are receiving these vaccines will be monitored for any potential side effects following vaccination. The study will collect data on the safety profile of these mRNA vaccines to ensure their continued safe use in preventing COVID-19 caused by SARS-CoV-2.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 12 and older who are scheduled to receive SPIKEVAX Bivalent or SPIKEVAX X vaccines.
Not a fit: Patients who are not receiving the SPIKEVAX vaccines or those deemed inappropriate for participation by the investigator may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the safety profile of SPIKEVAX vaccines, leading to improved patient confidence and vaccination strategies.
How similar studies have performed: Other studies have shown success in monitoring vaccine safety, making this approach consistent with established practices in post-marketing surveillance.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Wonju, Gangwon-do and 23 other locations
- Yonseimin Clinic — Wonju, Gangwon-do, Korea, Republic of (Recruiting)
- Hyundai Clinic — Bucheon, Gyeonggi-do, Korea, Republic of (Recruiting)
- Ma Hak ki Family Medicine Clinic — Bucheon, Gyeonggi-do, Korea, Republic of (Recruiting)
- Nalee Hospital — Gimpo, Gyeonggi-do, Korea, Republic of (Recruiting)
- COA ENT Clinic — Goyang, Gyeonggi-do, Korea, Republic of (Recruiting)
- Joon Pediatric Clinic — Gwangmyeong, Gyeonggi-do, Korea, Republic of (Recruiting)
- Janghyeon Medicine Clinic — Siheung, Gyeonggi-do, Korea, Republic of (Recruiting)
- Hanyang Union Rehabilitation Medicine Clinic — Yangju, Gyeonggi-do, Korea, Republic of (Recruiting)
- KimHyungjoo Clinic — Yangju, Gyeonggi-do, Korea, Republic of (Recruiting)
- Kium Children Hospital — Gunsan, Jeollabuk-do, Korea, Republic of (Recruiting)
- Sinsegie ENT Clinic — Busan, Korea, Republic of (Terminated)
- Jeil Family Medicine Clinic — Gwangju, Korea, Republic of (Withdrawn)
- Bupyeong Yonsei Medical Clinic — Incheon, Korea, Republic of (Recruiting)
- Inha University Hospital — Incheon, Korea, Republic of (Recruiting)
- Woori Medical Clinic — Seoul, Korea, Republic of (Recruiting)
- Yonsei Kids Pediatrics Clinic — Seoul, Korea, Republic of (Recruiting)
- Star Pediatrics Clinic — Seoul, Korea, Republic of (Recruiting)
- Seoul Bon Clinic — Seoul, Korea, Republic of (Recruiting)
- Dr Cho's Family Medical Clinic — Seoul, Korea, Republic of (Recruiting)
- Songpa Korea Neurosurgical Clinic — Seoul, Korea, Republic of (Recruiting)
- GF Pediatrics Clinic — Seoul, Korea, Republic of (Recruiting)
- Kim Il Joong Internal Medicine Clinic — Seoul, Korea, Republic of (Recruiting)
- New Yonsei ENT Clinic — Seoul, Korea, Republic of (Recruiting)
- Soo Orthopedics Clinic — Seoul, Korea, Republic of (Terminated)
Study contacts
- Study coordinator: Moderna WeCare Team
- Email: WeCareClinicalTrials@modernatx.com
- Phone: 1-866-663-3762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.