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

RECRUITINGSponsored by Sanofi Pasteur, a Sanofi Company
Actively Recruiting
SponsorSanofi Pasteur, a Sanofi Company
Started2025-01-17
Est. completion2026-04-13
Eligibility
Age2 Months – 6 Months
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06793826

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

Eligibility

Age: 2 Months – 6 MonthsHealthy volunteers accepted
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

Conditions3

Haemophilus Influenzae Type b ImmunisationHepatitis BLiver Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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