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

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ClinicalTrials.gov Identifier: NCT06333704
Recruitment Status : Recruiting
First Posted : March 27, 2024
Last Update Posted : March 27, 2024
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Tracking Information
First Submitted Date March 20, 2024
First Posted Date March 27, 2024
Last Update Posted Date March 27, 2024
Actual Study Start Date March 10, 2023
Estimated Primary Completion Date December 7, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 20, 2024)		 Number of Participants With AEs [ Time Frame: Up to 28 days post vaccination ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection.
Official Title A Multi-Centre, Prospective, Observational Post-Marketing Surveillance to Investigate the Long-Term Safety of SPIKEVAX BIVALENT and SPIKEVAX X Injection Under Routine Clinical Care in Korea
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The population of this survey is Korean participants vaccinated with SPIKEVAX BIVALENT or SPIKEVAX X injection who meet the inclusion/exclusion criteria.
Condition SARS-CoV-2
Intervention
  • Biological: SPIKEVAX Bivalent
    No study drug will be administered during this study as this is an observational study.
    Other Names:
    • SPIKEVAX Bivalent BA.1
    • SPIKEVAX BIVALENT BA.4/5
    • SARS-CoV-2-mRNA vaccine
  • Biological: SPIKEVAX X
    No study drug will be administered during this study as this is an observational study.
    Other Names:
    • SPIKEVAX XBB.1.5
    • SARS-CoV-2-mRNA vaccine
Study Groups/Cohorts 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.
Interventions:
  • Biological: SPIKEVAX Bivalent
  • Biological: SPIKEVAX X
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 20, 2024)		 3300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 7, 2026
Estimated Primary Completion Date December 7, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Moderna Clinical Trials Support Center 1-877-777-7187 clinicaltrials@modernatx.com
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT06333704
Other Study ID Numbers mRNA-1273-P924
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party ModernaTX, Inc.
Original Responsible Party Same as current
Current Study Sponsor ModernaTX, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account ModernaTX, Inc.
Verification Date March 2024