drugset / Trial / NCT01107275

Early Rabies Vaccine Immunization in Primary School Children

NCT01107275

Phase 3 Completed 703 enrolled Provincial Public Health Office, Phetchabun
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2002-11
Primary completion
2004-11
Completion
2008-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Rabies vaccine Vaccine 0.1 ml Other

Indications