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

Sanofi

Status: Enrolling

Conditions: Hepatitis B; Haemophilus Influenzae Type b Immunisation

Treatments: Biological: DTaP-IPV-Hep B-PRP-T combined vaccine

Study type: Observational

Funder types: Industry

Identifiers

NCT06793826

A3L46

U1111-1266-4935 (Registry Identifier)

Details and patient eligibility

About

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

Full description

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

Enrollment: 690 estimated patients

Sex: All

Ages: 2 to 6 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

690 participants in 1 patient group

Cohort

Description:

Infants from 2 months of age vaccinated with 1 dose of Hexaxim on the day of enrollment

Treatment:

Biological: DTaP-IPV-Hep B-PRP-T combined vaccine