Early Rabies Vaccine Immunization in Primary School Children

Phase 3

Completed

• Conditions: Rabies Prevention
• Interventions: Biological: rabies vaccine

• 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

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2004-11
• Study Completion: 2008-11
• Status Verified: 2010-04
• Study First Submitted: 2010-04-16
• Study First Submitted QC: 2010-04-19
• Last Update Submitted: 2010-04-19
• Study First Posted: 2010-04-20
• Last Update Posted: 2010-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 703

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 primary ID doses	rabies vaccine	two doses of rabies vaccines given intradermally on days 0 and 28
3 primary ID doses	rabies vaccine	three doses of rabies vaccines given intradermally on days 0, 7, and 28

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