Study of Sanofi Pasteur's dengue vaccine in healthy toddlers Aged 12 to 15 Months in the Philippines

• Conditions: Prevention of symptomatic dengue disease; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-001694-14-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-26
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1) Toddler in good health based on medical history and medical examination (Scr.+V_MV)
2) Toddler aged 12 to 15 months on the day of inclusion (Scr.)
3) Born at full term of pregnancy (= 37 weeks) and with a birth weight = 2.5 kg (Scr.)
4) Provision of informed consent form signed by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations) (Scr.)
5) Subject and parent/delegate able to attend all scheduled visits and comply with all trial procedures (Scr.)
6) Completion of previous vaccination program according to the national immunization schedule, except for measles (Scr.)
Are the trial subjects under 18? yes
Number of subjects for this age range: 210
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Family members from the Investigator or from the staff involved in the trial (Scr.)
2) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion (Scr.)
3) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) (Scr.)
4) History of central nervous system disorder or disease, including seizures (Scr.)
5) History of varicella, measles, mumps, rubella and hepatitis A; confirmed either clinically, serologically, or microbiologically (Scr.)
6) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion (Scr.)
7) Previous vaccination against MMR, hepatitis A or varicella (Scr.)
8) Previous vaccination against FV diseases (Scr.)
9) Known systemic hypersensitivity to any of the components of the vaccines, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances (Scr.)
10) Planned participation in another clinical trial during the present trial period (Scr.)
11) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination (Scr.+V_MV)
12) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response (Scr.+V_MV)
13) Planned receipt of any vaccine in the 4 weeks following the first trial vaccination (V_MV)
14) Human immunodeficiency virus (HIV) seropositivity in the blood sample taken at screening visit (V_MV)
15) Clinically significant laboratory abnormalities, as judged by the Investigator, in blood sample taken at screening visit (V_MV)
Should one of the conditions listed below occur, the Investigator was to postpone vaccination until the condition was resolved:
16) Febrile illness (temperature = 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator’s judgment (Scr.+V_MV)
17) Receipt of oral or injected antibiotic therapy within 72 hours prior to the vaccination (Scr.+V_MV)
18) Any vaccination received in the 4 weeks preceding vaccination (Scr.+V_MV)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified