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

Purpose

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.

Condition	Intervention	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
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Encephalitis Rabies

Drug Information available for: Rabies Vaccine

Genetic and Rare Diseases Information Center resources: Rabies Japanese Encephalitis

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Rabies virus neutralizing antibody concentrations [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Japanese encephalitis virus neutralizing antibody titers [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]


Enrollment:	200
Study Start Date:	August 2002
Study Completion Date:	September 2004
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility


Ages Eligible for Study:	12 Months to 18 Months (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694460

Locations


Thailand
Tropical Medicine, Mahidol University
Bangkok, Thailand, 10400

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators


Study Chair:	Novartis Vaccines	Novartis Vaccines

More Information


Responsible Party:	Novartis, Novartis Vaccines
ClinicalTrials.gov Identifier:	NCT00694460 History of Changes
Other Study ID Numbers:	M49P2
Study First Received:	May 30, 2008
Last Updated:	June 9, 2008
Health Authority:	Thailand: Food and Drug Administration

Keywords provided by Novartis:


rabies vaccination pre-exposure prophylaxis rabies virus neutralizing antibody

Additional relevant MeSH terms:


Encephalitis Rabies Encephalitis, Japanese Brain Diseases Central Nervous System Diseases Nervous System Diseases Rhabdoviridae Infections Mononegavirales Infections RNA Virus Infections Virus Diseases Encephalitis, Arbovirus	Arbovirus Infections Encephalitis, Viral Central Nervous System Viral Diseases Flavivirus Infections Flaviviridae Infections Infectious Encephalitis Central Nervous System Infections Vaccines Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016