Early Rabies Vaccine Immunization in Primary School Children

NCT01107275 | Completed Phase 3 DMC

• 1 other identifier: I49P1
• Study Type: interventional
• Target: 703
• Locations: 1 country
• Sites: 1

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.

Conditions

Rabies Prevention

Keywords

Rabies; PCECV; pre-exposure immunization; intradermal; children

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• rabies virus neuralizing antibody, assessed by RFFIT

  one year after the first booster dose

• rabies virus neuralizing antibody, assessed by RFFIT

  immediately before administration of the first booster dose

Study Arms (2)

2 primary ID doses

EXPERIMENTAL

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

Biological: rabies vaccine

3 primary ID doses

EXPERIMENTAL

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

Biological: rabies vaccine

Interventions

rabies vaccine BIOLOGICAL

intradermal vaccination

Also known as: PCECV, Rabipur

2 primary ID doses; 3 primary ID doses

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Provincial Public Health Office, Phetchabun: lead

Study Sites (1)

Phetchabun Province primary schools

Phetchabun, Phetchabun, Thailand

Location

Related 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. doi: 10.1016/j.jpeds.2007.02.044.

  PMID: 17643772 RESULT

MeSH Terms

Conditions

Rabies

Interventions

Rabies Vaccines

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Thavatchai Kamoltham, MD

  Provincial PHO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: April 20, 2010
• Study Start: November 1, 2002
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2008
• Last Updated: April 20, 2010

Record last verified: 2010-04

Locations

TH (1)