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
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
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sanofi Pasteur, a Sanofi Company |
Philippines, Thailand,
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
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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