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Early Rabies Vaccine Immunization in Primary School Children

NCT01107275 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 703

Last updated 2010-04-20

No results posted yet for this study

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

BIOLOGICAL

rabies vaccine

intradermal vaccination

Sponsors & Collaborators

  • Provincial Public Health Office, Phetchabun

    lead OTHER_GOV

Principal Investigators

  • Thavatchai Kamoltham, MD · Provincial PHO

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2004-11-30
Completion
2008-11-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01107275 on ClinicalTrials.gov