Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection.

SARS-CoV-2 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06333704
• Other study ID #: mRNA-1273-P924
• Status: Recruiting
• Start date: March 10, 2023
• Est. completion date: December 7, 2026

Study information

• Verified date: March 2024
• Source: ModernaTX, Inc.
• Contact: Moderna Clinical Trials Support Center
• Phone: 1-877-777-7187
• Email: clinicaltrials[@]modernatx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3300
• Est. completion date: December 7, 2026
• Est. primary completion date: December 7, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Biological:
• SPIKEVAX Bivalent
No study drug will be administered during this study as this is an observational study.
• SPIKEVAX X
No study drug will be administered during this study as this is an observational study.

Locations

Country	Name	City	State
Korea, Republic of	Hyundai Clinic	Bucheon	Gyeonggi-do
Korea, Republic of	Ma Hak ki Family Medicine Clinic	Bucheon	Gyeonggi-do
Korea, Republic of	Sinsegie ENT Clinic	Busan
Korea, Republic of	Nalee Hospital	Gimpo	Gyeonggi-do
Korea, Republic of	COA ENT Clinic	Goyang	Gyeonggi-do
Korea, Republic of	Kium Children Hospital	Gunsan	Jeollabuk-do
Korea, Republic of	Jeil Family Medicine Clinic	Gwangju
Korea, Republic of	Joon Pediatric Clinic	Gwangmyeong	Gyeonggi-do
Korea, Republic of	Bupyeong Yonsei Medical Clinic	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Dr Cho's Family Medical 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	Seoul Bon Clinic	Seoul
Korea, Republic of	Songpa Korea Neurosurgical Clinic	Seoul
Korea, Republic of	Soo Orthopedics Clinic	Seoul
Korea, Republic of	Star Pediatrics Clinic	Seoul
Korea, Republic of	Woori Medical Clinic	Seoul
Korea, Republic of	Yonsei Kids Pediatrics Clinic	Seoul
Korea, Republic of	Janghyeon Medicine Clinic	Siheung	Gyeonggi-do
Korea, Republic of	Yonseimin Clinic	Wonju	Gangwon-do
Korea, Republic of	Hanyang Union Rehabilitation Medicine Clinic	Yangju	Gyeonggi-do
Korea, Republic of	KimHyungjoo Clinic	Yangju	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With AEs		Up to 28 days post vaccination