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

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Jan 21, 2025

Keywords

ClinConnect Summary

This clinical trial is looking into the safety of a vaccine called Hexaxim, which protects against several diseases including Hepatitis B and Haemophilus Influenzae Type b. Researchers want to see if infants aged 2 months and older experience any side effects after receiving this vaccine in regular healthcare settings. The study is currently recruiting participants, and families with eligible infants may consider joining to help gather important information about the vaccine's safety.

To be part of this study, infants must be at least 2 months old and have a parent or guardian who agrees to participate by signing a consent form. It’s important that the infant receives their first dose of Hexaxim during the study enrollment. However, if a child has already been part of this study or is involved in another clinical trial at the same time, they won't be able to participate. Families can expect to help contribute to valuable research that may improve vaccine safety knowledge for future generations.

Gender

ALL

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