NCT02011763

Safety of Two Doses of Avaxim® 80U Pediatric (Inactivated Hepatitis A Vaccine) in Toddlers, Children and Adolescents

Safety of Two Doses of Avaxim® 80U Pediatric (Inactivated Hepatitis A Vaccine) Administered 6 Months Apart in Healthy Toddlers, Children and Adolescents Aged 12 Months to 15 Years in China

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 12 Months – 15 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to describe the safety profile of Avaxim 80U Pediatric, in order to confirm the good safety profile of the vaccine. Primary objective: * To describe the safety of Avaxim 80U Pediatric after each dose of vaccine administered 6 months apart, in subjects aged 12 months to 15 years.

Detailed description

Eligible participants aged 12 months to 15 years and 5 months (185 months) at enrollment will receive two doses of vaccine for the prevention of hepatitis A (6 months apart), and will be followed up for safety until 30 days after the second vaccination.

Conditions

• Hepatitis A
• Hepatitis A Virus

Interventions

Type	Name	Description
BIOLOGICAL	Avaxim 80U Pediatric: Inactivated Hepatitis A Virus	0.5 mL, Intramuscular (2 injection 6 months apart)

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-09-01
• Completion: 2015-08-01
• First posted: 2013-12-13
• Last updated: 2015-10-01

Locations

1 site across 1 country: China