Prevention of symptomatic dengue disease
Conditions
Interventions
Product Name: ChimeriVax™ Dengue Tetravalent Vaccine
Product Code: 323
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Live, attenuated, chimeric dengue virus serotype 1
Other descr
Sponsors
Sanofi Pasteur SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 2 to 45 years on the day of inclusion (Scr.) 2) Informed consent form signed by the subject and by the parent(s) or another legal representative for subjects under 18 years old (Scr.) 3) For a woman, inability to bear a child or negative serum pregnancy test at screening (Scr.) 4) Able to attend all scheduled visits and to comply with all trial procedures (Scr.+V01) 5) For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination and at least 4 weeks after each vaccination (Scr.+V01) 6) For a woman, inability to bear a child or negative urine pregnancy test on the day of the first injection (V01) Are the trial subjects under 18? yes Number of subjects for this age range: 108 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) History of thymic pathology (thymoma), thymectomy, or myasthenia (Scr.) 2) Breast-feeding (Scr.) 3) Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances (Scr.) 4) Previous vaccination against typhoïd or flavivirus diseases (including Japanese encephalitis, and yellow fever) (Scr.) 5) Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with trial procedures (Scr.) 6) Planned participation in another clinical trial during the present trial period (Scr.+V01) 7) History of flavivirus infection (confirmed either clinically, serologically or microbiologically) (Scr.+V01) 8) 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 (Scr.+V01) 9) Chronic illness at a stage that could interfere with trial conduct or completion (Scr.+V01) 10) Blood or blood-derived products received in the past three months (Scr.+V01) 11) Vaccination planned in the four weeks following any trial vaccination (Scr.+V01) 12) Flavivirus vaccination planned during the present trial period (Scr.+V01) 13) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent (Scr.+V01) 14) Participation in another clinical trial in the four weeks preceding the first trial vaccination (V01) 15) Any vaccination in the four weeks preceding the first trial vaccination (V01) 16) Human Immunodeficiency Virus (HIV), Hepatitis B (HBsAg) or Hepatitis C Virus (HCV) seropositivity in blood sample taken at Screening (V01) 17) Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening (V01)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety and reactogenicity Viremia Dengue immune responses and Persistence of antibodies;Secondary Objective: Detection of symptomatic dengue cases during the first four years of follow-up.;Primary end point(s): Safety and reactogenicity: Adverse events and biological abnormalities up to day 28 (D28) after each injection. Serious adverse events (SAEs) throughout the study as follows: all SAEs up to D28 after the third injection. SAEs that are neither accidents, hospitalizations related to the treatment of pre-existing conditions, or planned surgeries during the 4-year follow-up period. Deaths were collected whatever the cause. Hospitalized dengue cases collected retrospectively during the 5 year of follow-up. Viremia: Occurrence and maximum level of the four dengue serotypes in sera collected on the day of each injection, 7 and 14 days following the first and the second injections, and 7 days following the third injection in all the subjects. Dengue immune responses and Persistence of antibodies: - Neutralizing antibody levels against each of the four parental dengue virus serotype strains of ChimeriVax™ dengue tetravalent vaccine constructs and against the Thai Mahidol four dengue virus serotype strains, were measured on sera collected in all the subjects before injection, and 28 days after the first, second, and third injections and each year during four years after the last study injection. - Non-serotype specific Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibody levels were measured before injection and 28 days after the first, second, and third injections. ;Timepoint(s) of evaluation of this end point: Safety and reactogenicity: Adverse events and biological abnormalities up to D28 after each injection; SAEs throughout the study Viremia on D0, D7 after each injection, and D14 after the first and second injections. Dengue Iimmune responses (serotype specific neutralising antibodies, and non-serotype specific immunoglobulins [IgM, I | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Detection of symptomatic dengue cases.;Timepoint(s) of evaluation of this end point: Four-year follow-up period. | — |
Countries
Philippines
Contacts
Public ContactR&D, Clinical Development dpt
Sanofi Pasteur SA
Outcome results
None listed