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

Rabies Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694460
• Other study ID #: M49P2
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2008
• Last updated: June 9, 2008
• Start date: August 2002
• Est. completion date: September 2004

Study information

• Verified date: June 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 18 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis
• Pre-Exposure Prophylaxis
• Rabies

Intervention

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)
• 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)
• 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)
• 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)
• 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)

Locations

Country	Name	City	State
Thailand	Tropical Medicine, Mahidol University	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Novartis Vaccines

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rabies virus neutralizing antibody concentrations		2 years	No
Secondary	Japanese encephalitis virus neutralizing antibody titers		2 years	Yes