Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea

Recruiting

• Conditions: Hepatitis B; Haemophilus Influenzae Type b Immunisation
• Interventions: Biological: DTaP-IPV-Hep B-PRP-T combined vaccine

• Registration Number: NCT06793826
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief 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.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-17
• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-30
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-04-13
• Study Completion: 2026-04-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 690

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	DTaP-IPV-Hep B-PRP-T combined vaccine	Infants from 2 months of age vaccinated with 1 dose of Hexaxim on the day of enrollment

Primary Outcome Measures

Name	Time	Method
Number of participants reporting immediate adverse events/adverse drug reactions (AEs/ADRs)	Within 30 minutes post-vaccination	Unsolicited (spontaneously reported) systemic AEs/ADRs
Number of participants reporting serious adverse events / adverse drug reactions (SAEs / SADRs)	Up to 43 days post-vaccination	SAEs and SADRs
Number of participants reporting solicited injection site and systemic reactions	Up to 7 days post-vaccination	Solicited injection site reactions: tenderness; erythema; site swelling Solicited systemic reactions: vomiting; crying abnormal; drowsiness; appetite loss; irritability
Number of participants reporting unsolicited non-serious AEs/ADRs	Up to 28 days post-vaccination	Unsolicited non-serious AEs and ADRs

Trial Locations

Locations (2)

Investigational Site Number : 002; 🇰🇷 Cheonan, Korea, Republic of

Investigational Site Number : 001; 🇰🇷 Seoul, Korea, Republic of