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Completed

NCT Number: NCT01107275

Early Rabies Vaccine Immunization in Primary School Children

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.

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Key information

Conditions

Rabies Prevention Infections Mononegavirales Infections RNA Virus Infections Rabies Rhabdoviridae Infections Virus Diseases

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Phetchabun Province primary schools

Phetchabun, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rabies vaccine

Biological

intradermal vaccination

Other names: PCECV, Rabipur

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Provincial Public Health Office, Phetchabun

Other Gov

Registry information

Official study 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)

Acronym: I49P1

Important dates

Study start
2002
Primary completion
2004
Study completion
2008
First posted
Apr 20, 2010
Registry last updated
Apr 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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