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

CompletedN/A

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Hepatitis B, Haemophilus Influenzae Type b Immunisation

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

Countries: South 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

Eligibility overview

Sex: ALL

Age: 2 Months to 6 Months

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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

Locations (2)

Cheonan, South Korea
Seoul, South Korea