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Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00694460
First received: May 30, 2008
Last updated: June 9, 2008
Last verified: June 2008
History of Changes
  Purpose

This study evaluated the safety and immunogenicity of rabies vaccine and Japanese encephalitis vaccine in toddlers. All children developed adequate immune responses. Rabies vaccination with PCECV did not interfere with the antibody response to Japanese encephalitis vaccine. The rabies vaccine PCECV and Japanese encephalitis vaccine are safe and immunogenic when administered concomitantly to toddlers.


Condition Intervention Phase
Rabies
Japanese Encephalitis
Pre-Exposure Prophylaxis
 Biological: Three 1 mL doses of Rabies vaccine and two JE vaccine
Biological: Three 0.5 mL doses of Rabies vaccine and two JE vaccine
Biological: Three 0.1mL doses of Rabies Vaccine and two JE vaccine
Biological: Two 0.1mL doses of Rabies vaccine and two JE vaccine
Biological: Two doses of JE vaccine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II, Pilot, Randomized, Open-Label, Single-Center Study to Evaluate Immunogenicity, Safety and Booster Response of 3 Full Intramuscular Doses Versus 3 Half Intramuscular Doses Versus 3 Intradermal Doses Versus 2 Intradermal Doses of PCEC Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine as a Pre-Exposure Regimen in 12 to 18 Months Old Toddlers in Thailand.

Resource links provided by NLM:

MedlinePlus related topics: Encephalitis Rabies
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Rabies virus neutralizing antibody concentrations [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Japanese encephalitis virus neutralizing antibody titers [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: August 2002
Study Completion Date: September 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Three 1 mL doses of Rabies vaccine and two JE vaccine
Vaccination with purified chick embryo cell rabies vaccine 1.0 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)
Experimental: 2 Biological: Three 0.5 mL doses of Rabies vaccine and two JE vaccine
Vaccination with purified chick embryo cell rabies vaccine 0.5 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)
Experimental: 3 Biological: Three 0.1mL doses of Rabies Vaccine and two JE vaccine
Vaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)
Experimental: 4 Biological: Two 0.1mL doses of Rabies vaccine and two JE vaccine
Vaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0 and Day 28 (a total of 2 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)
Active Comparator: 5 Biological: Two doses of JE vaccine
Vaccination with Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL only subcutaneously on Day 0 and Day 7 (a total of 2 doses)

  Eligibility

Ages Eligible for Study:   12 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female 12-18 months old toddlers if they
  • are in good health at time of entry into the study
  • are available for all the visits scheduled in the study
  • have been granted a written informed consent, signed by their parents

Exclusion Criteria:

  • a history of rabies immunization
  • a history of Japanese encephalitis immunization or disease
  • a significant acute or chronic infectious disease at the time of enrollment
  • fever ≥ 38.0°C (axillary) or/and significant acute or chronic infection requiring antibiotic or antiviral therapy within the past 7 days before enrollment
  • being under treatment with corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment
  • administration of any vaccine within the past 14 days before enrollment
  • known immunodeficiency or an autoimmune disease
  • history of allergy to eggs, egg products
  • known hypersensitivity to neomycin, tetracycline, amphotericin-B
  • planned surgery during the study period
  • being enrolled in any other investigational trial contemporaneously
  • the family plans to leave the area of the study site before the end of study period
  • history of febrile convulsions
  • history of wheezing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694460

Locations
Thailand
Tropical Medicine, Mahidol University
Bangkok, Thailand, 10400
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis, Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00694460     History of Changes
Other Study ID Numbers: M49P2
Study First Received: May 30, 2008
Last Updated: June 9, 2008
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Novartis:
rabies vaccination
pre-exposure prophylaxis
rabies virus neutralizing antibody

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Rabies
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
 Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Rhabdoviridae Infections
Mononegavirales Infections

ClinicalTrials.gov processed this record on May 16, 2013