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Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT, SPIKEVAX X Injection, SPIKEVAX JN Injection and SPIKEVAX IN PRE-FILLED SYRINGE
Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT, SPIKEVAX X Injection, SPIKEVAX JN Injection and SPIKEVAX IN PRE-FILLED SYRINGE

NCT06333704

Active Not RecruitingN/A

Sponsor: ModernaTX, Inc.

Conditions: SARS-CoV-2

Interventions: SPIKEVAX Bivalent BA.1, SPIKEVAX Bivalent BA.4/5, SPIKEVAX XBB.1.5, SPIKEVAX JN.1

Countries: South Korea

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 overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* Participants should be 18 years or older for SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5, and 12 years or older for SPIKEVAX XBB.1.5 and SPIKEVAX JN.1.
* Participants of any age which is approved for the use of SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5, SPIKEVAX XBB.1.5, or SPIKEVAX JN.1 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, SPIKEVAX XBB.1.5, or SPIKEVAX JN.1 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, SPIKEVAX XBB.1.5, or SPIKEVAX JN.1.

Exclusion Criteria:

* Participant whose participation is deemed inappropriate at the investigator's discretion.

Note: Other protocol-defined inclusion/exclusion criteria may apply.
Locations (26)
  • Wŏnju, Gangwon-do, South Korea
  • Bucheon-si, Gyeonggi-do, South Korea
  • Bucheon-si, Gyeonggi-do, South Korea
  • Gimpo-si, Gyeonggi-do, South Korea
  • Goyang-si, Gyeonggi-do, South Korea
  • Gwangmyeong, Gyeonggi-do, South Korea
  • Namyangju, Gyeonggi-do, South Korea
  • Siheung, Gyeonggi-do, South Korea
  • Yangju, Gyeonggi-do, South Korea
  • Yangju, Gyeonggi-do, South Korea
  • Gunsan, Jeollabuk-do, South Korea
  • Busan, South Korea
  • Incheon, South Korea
  • Incheon, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea