NCT01107275

Early Rabies Vaccine Immunization in Primary School Children

Compare Immunogenicity, Safety and Long-term Booster Response After Primary Vaccination With 2 Intradermal Doses Versus 3 Intradermal Doses of PCEC Rabies Vaccine (Rabipur) in Healthy School Children in Thailand (5-8 Years of Age)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 703 (actual)
• Sponsor: Provincial Public Health Office, Phetchabun · Other Government
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Accepted

Summary

700 male and female healthy school-children (age 5 to 8) in Thailand were randomized to receive 2 or 3 primary rabies vaccine doses (PCECV, Rabipur) given intradermally in a dose of 0.1mL into the skin in the deltoid region. In a subset of 100 children blood was taken for rabies virus neutralizing antibody determination on day 49. All subjects were randomized to receive 2 booster doses (the recommended vaccination schedule for pre-immunized individuals in case of an exposure) on days 0 and 3, one, three or five years later. Blood was taken before and after booster for up to one year.Safety and tolerability of the vaccine was assessed and persistence of immune response up to 1 year after the booster doses.

Conditions

• Rabies Prevention

Interventions

Type	Name	Description
BIOLOGICAL	rabies vaccine	intradermal vaccination

Timeline

• Start date: 2002-11-01
• Primary completion: 2004-11-01
• Completion: 2008-11-01
• First posted: 2010-04-20
• Last updated: 2010-04-20

Locations

1 site across 1 country: Thailand