Trials / Active Not Recruiting
Active Not RecruitingNCT06333704
Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT, SPIKEVAX X Injection, SPIKEVAX JN Injection and SPIKEVAX IN PRE-FILLED SYRINGE
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
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 4,207 (actual)
- Sponsor
- ModernaTX, Inc. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SPIKEVAX Bivalent BA.1 | No study drug will be administered during this study as this is an observational study. |
| BIOLOGICAL | SPIKEVAX Bivalent BA.4/5 | No study drug will be administered during this study as this is an observational study. |
| BIOLOGICAL | SPIKEVAX XBB.1.5 | No study drug will be administered during this study as this is an observational study. |
| BIOLOGICAL | SPIKEVAX JN.1 | No study drug will be administered during this study as this is an observational study. |
Timeline
- Start date
- 2023-03-10
- Primary completion
- 2029-03-29
- Completion
- 2029-03-29
- First posted
- 2024-03-27
- Last updated
- 2026-04-16
Locations
26 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06333704. Inclusion in this directory is not an endorsement.