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

Moderna

Status: Enrolling

Conditions: SARS-CoV-2

Treatments: Biological: SPIKEVAX X; Biological: SPIKEVAX Bivalent

Study type: Observational

Funder types: Industry

Identifiers

NCT06333704

mRNA-1273-P924

Details and patient eligibility

About

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.

Enrollment: 4,206 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

4,206 participants in 1 patient group

SPIKEVAX BIVALENT or SPIKEVAX X

Description:

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.

Treatment:

Biological: SPIKEVAX Bivalent

Biological: SPIKEVAX X