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Early Rabies Vaccine Immunization in Primary School Children (I49P1)

This study has been completed.
Sponsor:
Information provided by:
Provincial Public Health Office, Phetchabun
ClinicalTrials.gov Identifier:
NCT01107275
First received: April 16, 2010
Last updated: April 19, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Rabies Prevention
 Biological: rabies vaccine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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)

Resource links provided by NLM:

MedlinePlus related topics: Rabies
U.S. FDA Resources

Further study details as provided by Provincial Public Health Office, Phetchabun:

Primary Outcome Measures:
  • rabies virus neuralizing antibody, assessed by RFFIT [ Time Frame: seven days after the first booster dose ] [ Designated as safety issue: No ]
    rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)


Secondary Outcome Measures:
  • rabies virus neuralizing antibody, assessed by RFFIT [ Time Frame: one year after the first booster dose ] [ Designated as safety issue: No ]
    rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)

  • rabies virus neuralizing antibody, assessed by RFFIT [ Time Frame: immediately before administration of the first booster dose ] [ Designated as safety issue: No ]
    rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)


Enrollment: 703
Study Start Date: November 2002
Study Completion Date: November 2008
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 primary ID doses
two doses of rabies vaccines given intradermally on days 0 and 28
 Biological: rabies vaccine
intradermal vaccination
Other Name: PCECV, Rabipur
Experimental: 3 primary ID doses
three doses of rabies vaccines given intradermally on days 0, 7, and 28
 Biological: rabies vaccine
intradermal vaccination
Other Name: PCECV, Rabipur

  Eligibility

Ages Eligible for Study:   5 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

Male and female 5-8 years old school children will be included in the study if:

  • Their parents or legal guardians have given the written informed consent prior to study entry;
  • They are in good health at time of study entry as determined by medical history, physical examination and clinical judgment of the investigator;
  • They are available for all the visits scheduled in the study.

Exclusion criteria:

Subjects are not to be enrolled into the study if:

  • They have a history of rabies immunization;
  • They have an acute infectious disease at the time of study entry;
  • They are under treatment with parenteral and/or oral steroids, immunosuppressive drugs, phenytoin or other specific anti-inflammatory drugs, or have taken chloroquine during the two month period before enrolment;
  • They have a known immunodeficiency or an autoimmune disease;
  • They have a known hypersensitivity to neomycin, tetracycline or amphotericin-B;
  • They have planned surgery during the first study period (49 days);
  • They are participating in any other trial of an investigational agent;
  • They have any condition which in the opinion of the investigator, might interfere with the evaluation of the study objectives.
  • The family plans to leave the area of the study site before the end of the study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107275

Locations
Thailand
Phetchabun Province primary schools
Phetchabun, Thailand
Sponsors and Collaborators
Provincial Public Health Office, Phetchabun
Investigators
Principal Investigator: Thavatchai Kamoltham, MD Provincial PHO
  More Information

Publications:

Responsible Party: Thavatchai Kamoltham, Ministry of health
ClinicalTrials.gov Identifier: NCT01107275     History of Changes
Other Study ID Numbers: I49P1
Study First Received: April 16, 2010
Last Updated: April 19, 2010
Health Authority: Thailand: Ethical Committee
Thailand: Ministry of Public Health

Keywords provided by Provincial Public Health Office, Phetchabun:
Rabies
PCECV
pre-exposure immunization
intradermal
children

Additional relevant MeSH terms:
Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013