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
South Korea
Locations

Yonseimin Clinic
Wŏnju 1833105, Gangwon-do 1843125, South Korea

Hyundai Clinic
Bucheon-si 1838716, Gyeonggi-do 1841610, South Korea

Ma Hak ki Family Medicine Clinic
Bucheon-si 1838716, Gyeonggi-do 1841610, South Korea

Nalee Hospital
Gimpo-si 1842936, Gyeonggi-do 1841610, South Korea

COA ENT Clinic
Goyang-si 1842485, Gyeonggi-do 1841610, South Korea

Joon Pediatric Clinic
Gwangmyeong 1948005, Gyeonggi-do 1841610, South Korea

Janghyeon Medicine Clinic
Siheung, Gyeonggi-do 1841610, South Korea

Hanyang Union Rehabilitation Medicine Clinic
Yangju 1832847, Gyeonggi-do 1841610, South Korea

KimHyungjoo Clinic
Yangju 1832847, Gyeonggi-do 1841610, South Korea

Kium Children Hospital
Gunsan 1842025, Jeollabuk-do 1845789, South Korea

Sinsegie ENT Clinic
Busan 1838524, South Korea

Jeil Family Medicine Clinic
Gwangju 1841811, South Korea

Bupyeong Yonsei Medical Clinic
Incheon 1843564, South Korea

Inha University Hospital
Incheon 1843564, South Korea

Woori Medical Clinic
Seoul 1835848, South Korea

Yonsei Kids Pediatrics Clinic
Seoul 1835848, South Korea

Star Pediatrics Clinic
Seoul 1835848, South Korea

Seoul Bon Clinic
Seoul 1835848, South Korea

Dr Cho's Family Medical Clinic
Seoul 1835848, South Korea

Songpa Korea Neurosurgical Clinic
Seoul 1835848, South Korea

GF Pediatrics Clinic
Seoul 1835848, South Korea

Kim Il Joong Internal Medicine Clinic
Seoul 1835848, South Korea

New Yonsei ENT Clinic
Seoul 1835848, South Korea

Soo Orthopedics Clinic
Seoul 1835848, South Korea

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
Coronavirus Infections
Virus Diseases
COVID-19
CVnCoV COVID-19 vaccine