NCT06793826Completed
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
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 713 (actual)
- First submitted
- 21 Jan 2025
- Start date
- 17 Jan 2025
- Primary completion date
- 15 Jan 2026
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Diseases
- Hepatitis B
- NCT number
- NCT06793826
What you commit to
- Study type: Observational
- Participants enrolled: 713
- From 17 Jan 2025 to the primary completion date, 15 Jan 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of enrollment in this study
- Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device or medical procedure
Other
- Deviational use (off-label vaccination) from the approval local product label of Hexaxim
Who the study is looking for
- An infant aged 2 months or more on the day of enrollment
- Infant whose parent or legal representative has signed and dated the ICF
- Receipt of 1 dose of Hexaxim on the day of enrollment according to the approved local product label (regardless of vaccinated dose)
Age in the registry: 2 months to 6 months · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Investigational Site Number : 002 Coordinator of this site? Confirm its status | Cheonan | South Korea | Unknown status |
| Investigational Site Number : 001 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.