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) (I49P1)

NCT01107275 Phase 3 COMPLETED

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.

Details

Lead sponsor	Provincial Public Health Office, Phetchabun
Phase	Phase 3
Status	COMPLETED
Enrolment	703
Start date	2002-11
Completion	2008-11

Conditions

• Rabies Prevention

Interventions

• rabies vaccine

Primary outcomes

• rabies virus neuralizing antibody, assessed by RFFIT — seven days after the first booster dose
  rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)

Countries

Thailand