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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4206 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-10

Study Completion Date

2028-12-10

Brief Summary

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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.

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Detailed Description

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Conditions

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SARS-CoV-2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SPIKEVAX BIVALENT or SPIKEVAX X

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.

SPIKEVAX Bivalent

Intervention Type BIOLOGICAL

No study drug will be administered during this study as this is an observational study.

SPIKEVAX X

Intervention Type BIOLOGICAL

No study drug will be administered during this study as this is an observational study.

Interventions

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SPIKEVAX Bivalent

No study drug will be administered during this study as this is an observational study.

Intervention Type BIOLOGICAL

SPIKEVAX X

No study drug will be administered during this study as this is an observational study.

Intervention Type BIOLOGICAL

Other Intervention Names

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SPIKEVAX Bivalent BA.1 SPIKEVAX BIVALENT BA.4/5 SARS-CoV-2-mRNA vaccine SPIKEVAX XBB.1.5 SARS-CoV-2-mRNA vaccine

Eligibility Criteria

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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.