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

Recruiting

• Conditions: SARS-CoV-2
• Interventions: Biological: SPIKEVAX Bivalent; Biological: SPIKEVAX X

• Registration Number: NCT06333704
• Lead Sponsor: ModernaTX, Inc.

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 available

Study Timeline

• Study Start: 2023-03-10
• Study First Submitted: 2024-03-20
• Study First Submitted QC: 2024-03-20
• Study First Posted: 2024-03-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2028-12-10
• Study Completion: 2028-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4206

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SPIKEVAX BIVALENT or SPIKEVAX X	SPIKEVAX Bivalent	Participants receiving at least 1 dose of SPIKEVAX BIVALENT vaccine or SPIKEVAX X Injection are monitored for safety parameters up to 28 days post vaccination.
SPIKEVAX BIVALENT or SPIKEVAX X	SPIKEVAX X	Participants receiving at least 1 dose of SPIKEVAX BIVALENT vaccine or SPIKEVAX X Injection are monitored for safety parameters up to 28 days post vaccination.

Primary Outcome Measures

Name	Time	Method
Number of Participants With AEs	Up to 28 days post vaccination

Trial Locations

Locations (24)

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

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