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

Sanofi Pasteur, a Sanofi Company690 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

690

Conditions

Hepatitis B Haemophilus Influenzae Type b Immunisation

Interventions

DTaP-IPV-Hep B-PRP-T combined vaccineBIOLOGICAL

prefilled syringe injection intramuscular

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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)

Investigational Site Number : 002

Cheonan, South Korea

RECRUITING

Investigational Site Number : 001

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Number of participants reporting immediate adverse events/adverse drug reactions (AEs/ADRs)

Unsolicited (spontaneously reported) systemic AEs/ADRs

Time frame: Within 30 minutes post-vaccination

Number of participants reporting serious adverse events / adverse drug reactions (SAEs / SADRs)

SAEs and SADRs

Time frame: Up to 43 days post-vaccination

Number of participants reporting solicited injection site and systemic reactions

Solicited injection site reactions: tenderness; erythema; site swelling Solicited systemic reactions: vomiting; crying abnormal; drowsiness; appetite loss; irritability

Time frame: Up to 7 days post-vaccination

Number of participants reporting unsolicited non-serious AEs/ADRs

Unsolicited non-serious AEs and ADRs

Time frame: Up to 28 days post-vaccination

Central Contacts

Trial Transparency email recommended (Toll free for US & Canada

CONTACT

800-633-1610 Contact-US@sanofi.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.