A Multi-centre, Prospective, Observational Post-marketing Surveillance to Investigate the Long-term Safety of SPIKEVAX BIVALENT, SPIKEVAX X Injection, SPIKEVAX JN Injection and SPIKEVAX IN PRE-FILLED SYRINGE Under Routine Clinical Care in Korea
Overview
- Phase
- Not Applicable
- Intervention
- SPIKEVAX Bivalent BA.1
- Conditions
- SARS-CoV-2
- Sponsor
- ModernaTX, Inc.
- Enrollment
- 4207
- Locations
- 49
- Primary Endpoint
- Number of Participants With AEs
- Status
- Active, not recruiting
- Last Updated
- 16 days ago
Overview
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.
Investigators
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.
- •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-
- •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.
Arms & Interventions
SPIKEVAX BIVALENT, SPIKEVAX X, SPIKEVAX JN, or SPIKEVAX IN PRE-FILLED SYRINGE
Participants receiving at least 1 dose of SPIKEVAX BIVALENT vaccine, SPIKEVAX X Injection, SPIKEVAX JN Injection, or SPIKEVAX in Pre-filled Syringe will be monitored for safety parameters up to 28 days post vaccination.
Intervention: SPIKEVAX Bivalent BA.1
SPIKEVAX BIVALENT, SPIKEVAX X, SPIKEVAX JN, or SPIKEVAX IN PRE-FILLED SYRINGE
Participants receiving at least 1 dose of SPIKEVAX BIVALENT vaccine, SPIKEVAX X Injection, SPIKEVAX JN Injection, or SPIKEVAX in Pre-filled Syringe will be monitored for safety parameters up to 28 days post vaccination.
Intervention: SPIKEVAX Bivalent BA.4/5
SPIKEVAX BIVALENT, SPIKEVAX X, SPIKEVAX JN, or SPIKEVAX IN PRE-FILLED SYRINGE
Participants receiving at least 1 dose of SPIKEVAX BIVALENT vaccine, SPIKEVAX X Injection, SPIKEVAX JN Injection, or SPIKEVAX in Pre-filled Syringe will be monitored for safety parameters up to 28 days post vaccination.
Intervention: SPIKEVAX XBB.1.5
SPIKEVAX BIVALENT, SPIKEVAX X, SPIKEVAX JN, or SPIKEVAX IN PRE-FILLED SYRINGE
Participants receiving at least 1 dose of SPIKEVAX BIVALENT vaccine, SPIKEVAX X Injection, SPIKEVAX JN Injection, or SPIKEVAX in Pre-filled Syringe will be monitored for safety parameters up to 28 days post vaccination.
Intervention: SPIKEVAX JN.1
Outcomes
Primary Outcomes
Number of Participants With AEs
Time Frame: Up to 28 days post vaccination