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

PHASE2CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

August 31, 2002

Primary Completion Date

August 31, 2004

Study Completion Date

September 30, 2004

Conditions
RabiesJapanese EncephalitisPre-Exposure Prophylaxis
Interventions
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)

Trial Locations (1)

10400

Tropical Medicine, Mahidol University, Bangkok

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Vaccines

INDUSTRY

lead

Novartis

INDUSTRY