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
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Actual Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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. |
Study Start Date : | August 2002 |
Actual Primary Completion Date : | August 2004 |
Actual Study Completion Date : | September 2004 |

Arm | Intervention/treatment |
---|---|
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) |
- Rabies virus neutralizing antibody concentrations [ Time Frame: 2 years ]
- Japanese encephalitis virus neutralizing antibody titers [ Time Frame: 2 years ]

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Ages Eligible for Study: | 12 Months to 18 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694460
Thailand | |
Tropical Medicine, Mahidol University | |
Bangkok, Thailand, 10400 |
Study Chair: | Novartis Vaccines | Novartis Vaccines |
Responsible Party: | Novartis, Novartis Vaccines |
ClinicalTrials.gov Identifier: | NCT00694460 |
Other Study ID Numbers: |
M49P2 |
First Posted: | June 10, 2008 Key Record Dates |
Last Update Posted: | June 10, 2008 |
Last Verified: | June 2008 |
rabies vaccination pre-exposure prophylaxis rabies virus neutralizing antibody |
Rabies Encephalitis, Japanese Encephalitis Brain Diseases Central Nervous System Diseases Nervous System Diseases Rhabdoviridae Infections Mononegavirales Infections RNA Virus Infections Virus Diseases Infections Encephalitis, Arbovirus |
Encephalitis, Viral Central Nervous System Viral Diseases Central Nervous System Infections Infectious Encephalitis Arbovirus Infections Vector Borne Diseases Flavivirus Infections Flaviviridae Infections Vaccines Immunologic Factors Physiological Effects of Drugs |