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

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

Study Overview

• Status: Completed
• Conditions: Hepatitis B; Haemophilus Influenzae Type b Immunisation
• Intervention / Treatment: Biological: DTaP-IPV-Hep B-PRP-T combined vaccine

Detailed Description

The duration of each enrolled participant's participation in the study will be up to 36 or 43 days.

• Study Type: Observational
• Enrollment (Actual): 713

Contacts and Locations

Study Locations

• South Korea
  • Cheonan, South Korea
    • Investigational Site Number : 002
  • Seoul, South Korea
    • Investigational Site Number : 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Infants aged 2 months or more will be recruited after vaccination with Hexaxim as per a routine healthcare visit and according to approved local product labeling, at study centers (general hospitals or clinics located in Korea). The number of subjects to enroll per site (10 sites) will be defined with each investigator

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort; Infants from 2 months of age vaccinated with 1 dose of Hexaxim on the day of enrollment	Biological: DTaP-IPV-Hep B-PRP-T combined vaccine; prefilled syringe injection intramuscular; Other Names: Hexaxim®

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi Pasteur, a Sanofi Company

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2025
• Primary Completion (Actual): January 15, 2026
• Study Completion (Actual): January 15, 2026

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis; Hepatitis B; DTaP-IPV-HB-PRP-T vaccine
• Other Study ID Numbers: A3L46; U1111-1266-4935 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No