Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
mRNA-1273-P924
Description
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.
Trial arms
Trial start
2023-03-10
Estimated PCD
2026-12-07
Trial end
2026-12-07
Status
Recruiting
Treatment
SPIKEVAX Bivalent
No study drug will be administered during this study as this is an observational study.
Arms:
SPIKEVAX BIVALENT or SPIKEVAX X
Other names:
SPIKEVAX Bivalent BA.1, SPIKEVAX BIVALENT BA.4/5, SARS-CoV-2-mRNA vaccine
SPIKEVAX X
No study drug will be administered during this study as this is an observational study.
Arms:
SPIKEVAX BIVALENT or SPIKEVAX X
Other names:
SPIKEVAX XBB.1.5, SARS-CoV-2-mRNA vaccine
Size
3300
Primary endpoint
Number of Participants With AEs
Up to 28 days post vaccination
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 3300, 'type': 'ESTIMATED'}}
Updated at
2024-03-27

1 organization

1 product

1 indication

Organization
ModernaTX
Product
SPIKEVAX
Indication
COVID-19