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

NCT06793826 | Completed

• 2 other identifiers: A3L46U1111-1266-4935
• Study Type: observational
• Target: 713
• Locations: 1 country
• Sites: 2

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

Conditions

Hepatitis B; Haemophilus Influenzae Type b Immunisation

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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

Interventions

DTaP-IPV-Hep B-PRP-T combined vaccine BIOLOGICAL

prefilled syringe injection intramuscular

Also known as: Hexaxim®

Cohort

Eligibility Criteria

• Age: 2 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Investigational Site Number : 002

Cheonan, South Korea

Location

Investigational Site Number : 001

Seoul, South Korea

Location

Biospecimen

Retention: NONE RETAINED

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MeSH Terms

Conditions

Hepatitis B

Interventions

DTaP-IPV-HB-PRP-T vaccine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start: January 17, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

KR (2)