Trials / Completed
CompletedNCT06793826
Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea
Post-marketing Surveillance Study for the Safety of Hexaxim®, a DTaP-IPV- HB-PRP~T Vaccine Administered to Infants From 2 Months of Age in Republic of Korea
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 713 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 2 Months – 6 Months
- Healthy volunteers
- Accepted
Summary
Primary objectives: To investigate the incidence of adverse events occurred following administration of Hexaxim in infants from 2 months of age under routine clinical practice, as per approved indications
Detailed description
The duration of each enrolled participant's participation in the study will be up to 36 or 43 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DTaP-IPV-Hep B-PRP-T combined vaccine | prefilled syringe injection intramuscular |
Timeline
- Start date
- 2025-01-17
- Primary completion
- 2026-01-15
- Completion
- 2026-01-15
- First posted
- 2025-01-27
- Last updated
- 2026-02-18
Locations
2 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06793826. Inclusion in this directory is not an endorsement.