Official Title
A Multi-centre, Prospective, Observational Post-marketing Surveillance to Investigate the Long-term Safety of SPIKEVAX BIVALENT, SPIKEVAX X Injection, SPIKEVAX JN Injection and SPIKEVAX IN PRE-FILLED SYRINGE 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

Active, not recruiting
SARS-CoV-2

Biological: SPIKEVAX Bivalent BA.1

No study drug will be administered during this study as this is an observational study.
Other Name: MODERNA SPIKEVAX BIVALENT (Elasomeran, Imelasomeran),SPIKEVAX BIVALENT (Elasomeran, Imelasomeran)

Biological: SPIKEVAX Bivalent BA.4/5

No study drug will be administered during this study as this is an observational study.
Other Name: SPIKEVAX BIVALENT (Elasomeran, Davesomeran),SPIKEVAX BIVALENT INJECTION DUO (Elasomeran, Davesomeran)

Biological: SPIKEVAX XBB.1.5

No study drug will be administered during this study as this is an observational study.
Other Name: SPIKEVAX X Injection

Biological: SPIKEVAX JN.1

No study drug will be administered during this study as this is an observational study.
Other Name: SPIKEVAX JN Injection,SPIKEVAX in Pre-filled Syringe

Eligibility Criteria

Inclusion Criteria:

- Participants should be 18 years or older for SPIKEVAX BIVALENT BA.1, SPIKEVAX
BIVALENT BA.4/5, and 12 years or older for SPIKEVAX XBB.1.5 and SPIKEVAX JN.1.

- Participants of any age which is approved for the use of SPIKEVAX BIVALENT BA.1,
SPIKEVAX BIVALENT BA.4/5, SPIKEVAX XBB.1.5, or SPIKEVAX JN.1 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, SPIKEVAX XBB.1.5, or SPIKEVAX JN.1 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, SPIKEVAX XBB.1.5, or SPIKEVAX JN.1.

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, 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
Namyangju, Gyeonggi-do, South Korea

Jeong's Family Medical 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

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

GF Pediatrics Clinic
Seoul, South Korea

Kim Il Joong Internal Medicine Clinic
Seoul, South Korea

New Yonsei ENT Clinic
Seoul, South Korea

Gangseo HANA ENT
Seoul, South Korea

Kim's Pediatrics Clinic
Seoul, South Korea

Soo Orthopedics Clinic
Seoul, South Korea

Not Provided

C&R Research, 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
2019-nCoV Vaccine mRNA-1273