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Active, Not Recruiting

NCT Number: NCT06333704

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

SARS-CoV-2 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yonseimin Clinic, Wŏnju, Gangwon-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SPIKEVAX Bivalent BA.1

Biological

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

Other names: MODERNA SPIKEVAX BIVALENT (Elasomeran, Imelasomeran), SPIKEVAX BIVALENT (Elasomeran, Imelasomeran)

SPIKEVAX Bivalent BA.4/5

Biological

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

Other names: SPIKEVAX BIVALENT (Elasomeran, Davesomeran), SPIKEVAX BIVALENT INJECTION DUO (Elasomeran, Davesomeran)

SPIKEVAX XBB.1.5

Biological

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

Other names: SPIKEVAX X Injection

SPIKEVAX JN.1

Biological

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

Other names: SPIKEVAX JN Injection, SPIKEVAX in Pre-filled Syringe

Primary outcomes

  1. Number of Participants With AEs

    Time frame: Up to 28 days post vaccination

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Collaborators

  • C&R Research, Inc.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Mar 27, 2024
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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