Haemophilus Influenzae Type b Immunisation, Hepatitis B
Conditions
Brief 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
Detailed description
The duration of each enrolled participant's participation in the study will be up to 36 or 43 days.
Interventions
BIOLOGICALDTaP-IPV-Hep B-PRP-T combined vaccine
prefilled syringe injection intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Months to 6 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants reporting immediate adverse events/adverse drug reactions (AEs/ADRs) | Within 30 minutes post-vaccination | Unsolicited (spontaneously reported) systemic AEs/ADRs |
| Number of participants reporting serious adverse events / adverse drug reactions (SAEs / SADRs) | Up to 43 days post-vaccination | SAEs and SADRs |
| Number of participants reporting solicited injection site and systemic reactions | Up to 7 days post-vaccination | Solicited injection site reactions: tenderness; erythema; site swelling Solicited systemic reactions: vomiting; crying abnormal; drowsiness; appetite loss; irritability |
| Number of participants reporting unsolicited non-serious AEs/ADRs | Up to 28 days post-vaccination | Unsolicited non-serious AEs and ADRs |
Countries
South Korea
Contacts
STUDY_DIRECTORClinical Sciences & Operations
Sanofi Pasteur, a Sanofi Company
Outcome results
None listed