Monitoring the safety of a combined vaccine in infants in South 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
This study is testing the safety of a combined vaccine for infants in South Korea to see if it causes any side effects after they receive it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 690 (estimated) |
| Ages | 2 Months to 6 Months |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 2 sites (Cheonan and 1 other locations) |
| Trial ID | NCT06793826 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety of the DTaP-IPV-Hep B-PRP-T vaccine, known as Hexaxim, in infants aged 2 months and older. Participants will be monitored for adverse events following vaccination under routine clinical practice. The study will track the incidence of any adverse reactions for a duration of up to 43 days post-vaccination. The findings will help ensure the vaccine's safety profile in the target population.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 2 months or older who are receiving the Hexaxim vaccine.
Not a fit: Patients who have previously participated in this study or are receiving off-label vaccinations will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the vaccine's safety, leading to improved vaccination practices and confidence among parents.
How similar studies have performed: Other post-marketing surveillance studies have successfully demonstrated the safety of vaccines, making this approach well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Deviational use (off-label vaccination) from the approval local product label of Hexaxim * 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
Where this trial is running
Cheonan and 1 other locations
- Investigational Site Number : 002 — Cheonan, Korea, Republic of (Recruiting)
- Investigational Site Number : 001 — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada
- Email: Contact-US@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.