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Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

Primary Purpose

Japanese Encephalitis, Hepatitis A

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Japanese encephalitis vaccine

Japanese encephalitis vaccine (Acambis)

Hepatitis A vaccine

About this trial

This is an interventional prevention trial for Japanese Encephalitis focused on measuring Japanese encephalitis, Hepatitis A, Inactivated Mouse-Brain

Eligibility Criteria

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

Inclusion Criteria :

Aged 12 to 18 months on the day of inclusion.
In good general health, without significant medical history.
Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations.
Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
Completion of vaccinations according to the national immunization schedule.

Exclusion Criteria :

Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
Planned participation in another clinical trial during the present trial period.
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing any of the same substances.
Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response.
Administration of any anti-viral within 2 months preceding V01.
History of central nervous system disorder or disease, including seizures.
Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
Personal human immunodeficiency virus seropositivity in the blood sample taken at screening.
Receipt of any JE vaccine or hepatitis A vaccine.
Previous vaccination against flavivirus disease.
History of flavivirus infection (confirmed either clinically, serologically or microbiologically)
Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination.
Febrile illness (temperature ≥38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

JE-CV GPO MBP (Lot 1)

JE-CV GPO MBP (Lot 2)

JE-CV GPO MBP (Lot 3)

JE-CV WRAIR (Group 4)

Hepatitis A (Group 5)

Arm Description

Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1.

Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 2.

Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 3.

Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)

Participants 12 to 18 months of age randomized to receive Hepatitis A vaccine

Outcomes

Primary Outcome Measures

Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots

Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 1/dil and post-vaccination titer ≥ 10 1/dil, or participants with pre-vaccination titer ≥ 10 1/dil and 4-fold increase from pre- to post-vaccination.

Secondary Outcome Measures

Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV

Anti-Japanese Encephalitis Chimeric Virus antibodies were measured using the 50% plaque reduction neutralization test (PRNT50) assay.

Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV

Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the PRNT50 assay. Seroprotection was defined as the proportion of subjects with a JE CV virus PRNT50 neutralizing antibody titer ≥10 1/dilution (dil).

Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine

Anti Japanese encephalitis chimeric virus antibodies were measured using the PRNT50 assay.

Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine.

Solicited injection site: Tenderness, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Tenderness, cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling ≥5 cm. Grade 3 systemic reactions: Fever, temperature >39.5˚C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal, >3 hours; Drowsiness, sleeping most of the time or difficult to wake up; Appetite Lost, refuses ≥3 or most feeds/meals; and Irritability, inconsolable.

Full Information

NCT ID

NCT00735644

First Posted

August 14, 2008

Last Updated

April 1, 2015

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00735644

Brief Title

Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

Official Title

Lot-to-lot Consistency, Bridging, and Safety Trial of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in toddlers aged 12-18 months. Primary objective: To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi pasteur. Secondary objective: To describe the safety of vaccination in all subjects

Detailed Description

This is a Phase III trial in toddlers in Thailand and the Philippines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Japanese Encephalitis, Hepatitis A

Keywords

Japanese encephalitis, Hepatitis A, Inactivated Mouse-Brain

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

JE-CV GPO MBP (Lot 1)

Arm Type

Experimental

Arm Description

Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1.

Arm Title

JE-CV GPO MBP (Lot 2)

Arm Type

Experimental

Arm Description

Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 2.

Arm Title

JE-CV GPO MBP (Lot 3)

Arm Type

Experimental

Arm Description

Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 3.

Arm Title

JE-CV WRAIR (Group 4)

Arm Type

Active Comparator

Arm Description

Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)

Arm Title

Hepatitis A (Group 5)

Arm Type

Sham Comparator

Arm Description

Participants 12 to 18 months of age randomized to receive Hepatitis A vaccine

Intervention Type

Biological

Intervention Name(s)

Japanese encephalitis vaccine

Other Intervention Name(s)

ChimeriVax™-JE

Intervention Description

0.5 mL, Subcutaneous

Intervention Type

Biological

Intervention Name(s)

Japanese encephalitis vaccine

Other Intervention Name(s)

ChimeriVax™-JE

Intervention Description

0.5 mL, Subcutaneous

Intervention Type

Biological

Intervention Name(s)

Japanese encephalitis vaccine

Other Intervention Name(s)

ChimeriVax™-JE

Intervention Description

0.5 mL, Subcutaneous

Intervention Type

Biological

Intervention Name(s)

Japanese encephalitis vaccine (Acambis)

Intervention Description

0.5 mL, Subcutaneous

Intervention Type

Biological

Intervention Name(s)

Hepatitis A vaccine

Other Intervention Name(s)

Avaxim® 80U Pediatric

Intervention Description

0.5 mL, Intramuscular

Primary Outcome Measure Information:

Title

Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots

Description

Time Frame

Day 0 (pre-vaccination) and Day 28 post-vaccination

Secondary Outcome Measure Information:

Title

Description

Anti-Japanese Encephalitis Chimeric Virus antibodies were measured using the 50% plaque reduction neutralization test (PRNT50) assay.

Time Frame

Day 0 (pre-vaccination) and Day 28 post-vaccination

Title

Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV

Description

Time Frame

Day 0 (pre-vaccination) and Day 28 post-vaccination

Title

Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine

Description

Anti Japanese encephalitis chimeric virus antibodies were measured using the PRNT50 assay.

Time Frame

Day 0 (pre-vaccination) and Day 28 post-vaccination

Title

Description

Time Frame

Day 0 up to Day 14 post-vaccination

Other Pre-specified Outcome Measures:

Title

Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine.

Description

Flavivirus (FV) positive was defined as anti-JE against homologous virus strain ≥10 l/dil or anti dengue against at least one serotype ≥10 l/dil. FV negative was defined as anti-JE against homologous virus strain <10 l/dil and anti-dengue against the 4 serotypes <10 l/dilution.

Time Frame

Day 0 (pre-vaccination)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Months

Maximum Age & Unit of Time

18 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria : Aged 12 to 18 months on the day of inclusion. In good general health, without significant medical history. Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations. Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures. Completion of vaccinations according to the national immunization schedule. Exclusion Criteria : Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination. Planned participation in another clinical trial during the present trial period. Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy. Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing any of the same substances. Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator. Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response. Administration of any anti-viral within 2 months preceding V01. History of central nervous system disorder or disease, including seizures. Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. Planned receipt of any vaccine in the 4 weeks following any trial vaccination. Personal human immunodeficiency virus seropositivity in the blood sample taken at screening. Receipt of any JE vaccine or hepatitis A vaccine. Previous vaccination against flavivirus disease. History of flavivirus infection (confirmed either clinically, serologically or microbiologically) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination. Febrile illness (temperature ≥38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Sanofi Pasteur Inc.

Official's Role

Study Director

Facility Information:

City

Alabang

Country

Philippines

City

Bayanan

Country

Philippines

City

Buli

Country

Philippines

City

Cupang

Country

Philippines

City

Sucat

Country

Philippines

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

City

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

22777096

Citation

Feroldi E, Pancharoen C, Kosalaraksa P, Watanaveeradej V, Phirangkul K, Capeding MR, Boaz M, Gailhardou S, Bouckenooghe A. Single-dose, live-attenuated Japanese encephalitis vaccine in children aged 12-18 months: randomized, controlled phase 3 immunogenicity and safety trial. Hum Vaccin Immunother. 2012 Jul;8(7):929-37. doi: 10.4161/hv.20071. Epub 2012 Jul 1.

Results Reference

result

PubMed Identifier

24656175

Citation

Bonaparte M, Dweik B, Feroldi E, Meric C, Bouckenooghe A, Hildreth S, Hu B, Yoksan S, Boaz M. Immune response to live-attenuated Japanese encephalitis vaccine (JE-CV) neutralizes Japanese encephalitis virus isolates from south-east Asia and India. BMC Infect Dis. 2014 Mar 21;14:156. doi: 10.1186/1471-2334-14-156.

Results Reference

result

Links:

URL

http://www.sanofipasteur.com

Description

Related Info

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Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

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