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

Hepatitis A Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735644
• Other study ID #: JEC02
• Status: Completed
• Phase: Phase 3
• First received: August 14, 2008
• Last updated: April 1, 2015
• Start date: August 2008
• Est. completion date: August 2009

Study information

• Verified date: April 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Department of HealthThailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: August 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 18 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Hepatitis
• Hepatitis A
• Japanese Encephalitis

Intervention

Biological:
• Japanese encephalitis vaccine
0.5 mL, Subcutaneous
• Japanese encephalitis vaccine
0.5 mL, Subcutaneous
• Japanese encephalitis vaccine
0.5 mL, Subcutaneous
• Japanese encephalitis vaccine (Acambis)
0.5 mL, Subcutaneous
• Hepatitis A vaccine
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

Philippines,  Thailand, 

References & Publications (2)

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 Inf — View 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 immunogenic — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine.	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.	Day 0 (pre-vaccination)	No
Primary	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.	Day 0 (pre-vaccination) and Day 28 post-vaccination	No
Secondary	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.	Day 0 (pre-vaccination) and Day 28 post-vaccination	No
Secondary	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).	Day 0 (pre-vaccination) and Day 28 post-vaccination	No
Secondary	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.	Day 0 (pre-vaccination) and Day 28 post-vaccination	No
Secondary	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.	Day 0 up to Day 14 post-vaccination	No

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