Official Title
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
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 Provided

Recruiting
SARS-CoV-2

Biological: SPIKEVAX Bivalent

No study drug will be administered during this study as this is an observational study.
Other Name: SPIKEVAX Bivalent BA.1,SPIKEVAX BIVALENT BA.4/5,SARS-CoV-2-mRNA vaccine

Biological: SPIKEVAX X

No study drug will be administered during this study as this is an observational study.
Other Name: SPIKEVAX XBB.1.5,SARS-CoV-2-mRNA vaccine

Eligibility 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.

Eligibility Gender
All
Eligibility Age
Minimum: 12 Years ~ Maximum: N/A
Countries
Korea, Republic of
Locations

Yonseimin Clinic
Wonju, Gangwon-do, Korea, Republic of

Hyundai Clinic
Bucheon, Gyeonggi-do, Korea, Republic of

Ma Hak ki Family Medicine Clinic
Bucheon, Gyeonggi-do, Korea, Republic of

Nalee Hospital
Gimpo, Gyeonggi-do, Korea, Republic of

COA ENT Clinic
Goyang, Gyeonggi-do, Korea, Republic of

Joon Pediatric Clinic
Gwangmyeong, Gyeonggi-do, Korea, Republic of

Janghyeon Medicine Clinic
Siheung, Gyeonggi-do, Korea, Republic of

Hanyang Union Rehabilitation Medicine Clinic
Yangju, Gyeonggi-do, Korea, Republic of

KimHyungjoo Clinic
Yangju, Gyeonggi-do, Korea, Republic of

Kium Children Hospital
Gunsan, Jeollabuk-do, Korea, Republic of

Sinsegie ENT Clinic
Busan, Korea, Republic of

Jeil Family Medicine Clinic
Gwangju, Korea, Republic of

Bupyeong Yonsei Medical Clinic
Incheon, Korea, Republic of

Inha University Hospital
Incheon, Korea, Republic of

Woori Medical Clinic
Seoul, Korea, Republic of

Yonsei Kids Pediatrics Clinic
Seoul, Korea, Republic of

Star Pediatrics Clinic
Seoul, Korea, Republic of

Seoul Bon Clinic
Seoul, Korea, Republic of

Dr Cho's Family Medical Clinic
Seoul, Korea, Republic of

Songpa Korea Neurosurgical Clinic
Seoul, Korea, Republic of

GF Pediatrics Clinic
Seoul, Korea, Republic of

Kim Il Joong Internal Medicine Clinic
Seoul, Korea, Republic of

New Yonsei ENT Clinic
Seoul, Korea, Republic of

Soo Orthopedics Clinic
Seoul, Korea, Republic of

Contacts

Moderna WeCare Team
1-866-663-3762
WeCareClinicalTrials@modernatx.com

Not Provided

ModernaTX, Inc.
NCT Number
Keywords
mRNA-1273
mRNA-1273 vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
Covid-19
COVID-19 vaccine
Moderna
MeSH Terms
Vaccines