Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection.
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
ModernaTX, Inc.
4,206 participants
Mar 10, 2023
OBSERVATIONAL
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
Inclusion Criteria4
- 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 Criteria1
- Participant whose participation is deemed inappropriate at the investigator's discretion.
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Interventions
No study drug will be administered during this study as this is an observational study.
No study drug will be administered during this study as this is an observational study.
Locations(24)
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NCT06333704