Trial | NCT01107275  Report issue

Title

Early Rabies Vaccine Immunization in Primary School Children
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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    703
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.
Study Started
Nov 30
2002
Primary Completion
Nov 30
2004
Study Completion
Nov 30
2008
Last Update
Apr 20
2010
Estimate

Biological rabies vaccine

intradermal vaccination

  • Other names: PCECV, Rabipur

2 primary ID doses Experimental

two doses of rabies vaccines given intradermally on days 0 and 28

3 primary ID doses Experimental

three doses of rabies vaccines given intradermally on days 0, 7, and 28

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.
No Results Posted