Early Rabies Vaccine Immunization in Primary School Children

Rabies Prevention Clinical Trial

— I49P1  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107275
• Other study ID #: I49P1
• Status: Completed
• Phase: Phase 3
• First received: April 16, 2010
• Last updated: April 19, 2010
• Start date: November 2002
• Est. completion date: November 2008

Study information

• Verified date: April 2010
• Source: Provincial Public Health Office, Phetchabun
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical CommitteeThailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 703
• Est. completion date: November 2008
• Est. primary completion date: November 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 8 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Rabies
• Rabies Prevention

Intervention

Biological:
• rabies vaccine
intradermal vaccination

Locations

Country	Name	City	State
Thailand	Phetchabun Province primary schools	Phetchabun

Sponsors (1)

Lead Sponsor	Collaborator
Provincial Public Health Office, Phetchabun

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Kamoltham T, Thinyounyong W, Phongchamnaphai P, Phraisuwan P, Khawplod P, Banzhoff A, Malerczyk C. Pre-exposure rabies vaccination using purified chick embryo cell rabies vaccine intradermally is immunogenic and safe. J Pediatr. 2007 Aug;151(2):173-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rabies virus neuralizing antibody, assessed by RFFIT	rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)	seven days after the first booster dose	No
Secondary	rabies virus neuralizing antibody, assessed by RFFIT	rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)	one year after the first booster dose	No
Secondary	rabies virus neuralizing antibody, assessed by RFFIT	rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)	immediately before administration of the first booster dose	No