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

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ClinicalTrials.gov Identifier: NCT00694460
Recruitment Status : Completed
First Posted : June 10, 2008
Last Update Posted : June 10, 2008
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE May 30, 2008
First Posted Date  ICMJE June 10, 2008
Last Update Posted Date June 10, 2008
Study Start Date  ICMJE August 2002
Actual Primary Completion Date August 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2008)
Rabies virus neutralizing antibody concentrations [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2008)
Japanese encephalitis virus neutralizing antibody titers [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Rabies
  • Japanese Encephalitis
  • Pre-Exposure Prophylaxis
Intervention  ICMJE
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Biological: Three 1 mL doses of Rabies vaccine and two JE vaccine
  • Experimental: 2
    Intervention: Biological: Three 0.5 mL doses of Rabies vaccine and two JE vaccine
  • Experimental: 3
    Intervention: Biological: Three 0.1mL doses of Rabies Vaccine and two JE vaccine
  • Experimental: 4
    Intervention: Biological: Two 0.1mL doses of Rabies vaccine and two JE vaccine
  • Active Comparator: 5
    Intervention: Biological: Two doses of JE vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2008)
200
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2004
Actual Primary Completion Date August 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 18 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00694460
Other Study ID Numbers  ICMJE M49P2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis, Novartis Vaccines
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Novartis Vaccines
Investigators  ICMJE
Study Chair: Novartis Vaccines Novartis Vaccines
PRS Account Novartis
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP