Early Rabies Vaccine Immunization in Primary School Children
- Conditions
- Rabies Prevention
- Registration Number
- NCT01107275
- Lead Sponsor
- Provincial Public Health Office, Phetchabun
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 703
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method rabies virus neuralizing antibody, assessed by RFFIT immediately before administration of the first booster dose rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)
Trial Locations
- Locations (1)
Phetchabun Province primary schools
🇹🇭Phetchabun, Thailand
Phetchabun Province primary schools🇹🇭Phetchabun, Thailand