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

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

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

Infants aged 2 months or more will be recruited after vaccination with Hexaxim as per a routine healthcare visit and according to approved local product labeling, at study centers (general hospitals or clinics located in Korea). The number of subjects to enroll per site (10 sites) will be defined with each investigator

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org