search
Back to results

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

Primary Purpose

Rabies, Japanese Encephalitis, Pre-Exposure Prophylaxis

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Three 1 mL doses of Rabies vaccine and two JE vaccine
Three 0.5 mL doses of Rabies vaccine and two JE vaccine
Three 0.1mL doses of Rabies Vaccine and two JE vaccine
Two 0.1mL doses of Rabies vaccine and two JE vaccine
Two doses of JE vaccine
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rabies focused on measuring rabies vaccination, pre-exposure prophylaxis, rabies virus neutralizing antibody

Eligibility Criteria

12 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tropical Medicine, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

4

5

Arm Description

Outcomes

Primary Outcome Measures

Rabies virus neutralizing antibody concentrations

Secondary Outcome Measures

Japanese encephalitis virus neutralizing antibody titers

Full Information

First Posted
May 30, 2008
Last Updated
June 9, 2008
Sponsor
Novartis
Collaborators
Novartis Vaccines
search

1. Study Identification

Unique Protocol Identification Number
NCT00694460
Brief Title
Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies, Japanese Encephalitis, Pre-Exposure Prophylaxis
Keywords
rabies vaccination, pre-exposure prophylaxis, rabies virus neutralizing antibody

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Arm Title
5
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Three 1 mL doses of Rabies vaccine and two JE vaccine
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
Three 0.5 mL doses of Rabies vaccine and two JE vaccine
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
Three 0.1mL doses of Rabies Vaccine and two JE vaccine
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
Two 0.1mL doses of Rabies vaccine and two JE vaccine
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
Two doses of JE vaccine
Intervention Description
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)
Primary Outcome Measure Information:
Title
Rabies virus neutralizing antibody concentrations
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Japanese encephalitis virus neutralizing antibody titers
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
Tropical Medicine, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs