Sanofi
English

Recruiting

NCT06793826

Hepatitis B

Haemophilus Influenzae Type b Immunisation

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

+ 2 month(s) and - 6 month(s)

Study targets participants aged from 2 month(s) to 6 month(s)

All gender

This study targets all gender participants

N/A

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690 participants

Study involves a large group of participants

2 locations

Available in numerous locations

Study Overview

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 Details

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

Eligibility 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
Updated on January 2026. Study ID: NCT06793826