Clinical trial NCT06333704: Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection.
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: SARS-CoV-2
Keywords: mRNA-1273
mRNA-1273 vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
COVID-19
COVID-19 Vaccine
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-27
Enrollment: 4206
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of this survey is Korean participants vaccinated with SPIKEVAX BIVALENT or SPIKEVAX X injection who meet the inclusion/exclusion criteria.

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.


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.

Primary outcomes:
measure: Number of Participants With AEs
timeFrame: Up to 28 days post vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Yonseimin Clinic
state: Gangwon-do
city: Bucheon
country: Korea, Republic of
facility: Hyundai Clinic
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: Ma Hak ki Family Medicine Clinic
state: Gyeonggi-do
city: Gimpo
country: Korea, Republic of
facility: Nalee Hospital
state: Gyeonggi-do
city: Goyang
country: Korea, Republic of
facility: COA ENT Clinic
state: Gyeonggi-do
city: Gwangmyeong
country: Korea, Republic of
facility: Joon Pediatric Clinic
state: Gyeonggi-do
city: Siheung
country: Korea, Republic of
facility: Janghyeon Medicine Clinic
state: Gyeonggi-do
city: Yangju
country: Korea, Republic of
facility: Hanyang Union Rehabilitation Medicine Clinic
state: Gyeonggi-do
city: Yangju
country: Korea, Republic of
facility: KimHyungjoo Clinic
state: Gyeonggi-do
city: Gunsan
country: Korea, Republic of
facility: Kium Children Hospital
state: Jeollabuk-do
city: Busan
country: Korea, Republic of
facility: Sinsegie ENT Clinic
city: Gwangju
country: Korea, Republic of
facility: Jeil Family Medicine Clinic
city: Incheon
country: Korea, Republic of
facility: Bupyeong Yonsei Medical Clinic
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Woori Medical Clinic
city: Seoul
country: Korea, Republic of
facility: Yonsei Kids Pediatrics Clinic
city: Seoul
country: Korea, Republic of
facility: Star Pediatrics Clinic
city: Seoul
country: Korea, Republic of
facility: Seoul Bon Clinic
city: Seoul
country: Korea, Republic of
facility: Dr Cho's Family Medical Clinic
city: Seoul
country: Korea, Republic of
facility: Songpa Korea Neurosurgical Clinic
city: Seoul
country: Korea, Republic of
facility: GF Pediatrics Clinic
city: Seoul
country: Korea, Republic of
facility: Kim Il Joong Internal Medicine Clinic
city: Seoul
country: Korea, Republic of
facility: New Yonsei ENT Clinic
city: Seoul
country: Korea, Republic of
facility: Soo Orthopedics Clinic
Study officials:
References: