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Early Rabies Vaccine Immunization in Primary School Children (I49P1)

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ClinicalTrials.gov Identifier: NCT01107275
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : April 20, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Rabies Prevention Biological: rabies vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 703 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : November 2002
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. rabies virus neuralizing antibody, assessed by RFFIT [ Time Frame: 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 :
  1. rabies virus neuralizing antibody, assessed by RFFIT [ Time Frame: one year after the first booster dose ]
    rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)

  2. rabies virus neuralizing antibody, assessed by RFFIT [ Time Frame: 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)



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Ages Eligible for Study:   5 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107275


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

Publications of Results:
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Responsible Party: Thavatchai Kamoltham, Ministry of health
ClinicalTrials.gov Identifier: NCT01107275     History of Changes
Other Study ID Numbers: I49P1
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: April 20, 2010
Last Verified: April 2010

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

Additional relevant MeSH terms:
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Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs