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Sponsor: Sanofi Pasteur, a Sanofi Company
Conditions: Dengue, Dengue Fever, Dengue Hemorrhagic Fever
Interventions: Live, attenuated, dengue serotype 1, 2, 3, 4 virus, Placebo: Sodium chloride (NaCl) 0.9%
Countries: Indonesia, Malaysia, Philippines, Thailand, Vietnam
The aim of the trial was to assess the efficacy of the CYD dengue vaccine in preventing symptomatic, virologically-confirmed dengue (VCD) cases. Primary Objective: To assess the efficacy of CYD dengue vaccine after 3 vaccinations at 0, 6, and 12 months in preventing symptomatic VCD cases, regardless of the severity, due to any of the four serotypes in children aged 2 to 14 years at the time of inclusion. Secondary Objectives: * To describe the efficacy of CYD dengue vaccine in preventing symptomatic VCD cases after the third dose to the end of the Active Phase, after at least 1 dose, and after 2 doses. * To describe the occurrence of serious adverse events (SAEs), including SAEs of special interest in all participants throughout the trial period. * To describe the occurrence of hospitalized virologically-confirmed dengue (VCD) cases and the occurrence of severe (clinically-severe or as per World Health Organization (WHO) criteria) VCD cases, throughout the Surveillance Expansion period (SEP) and throughout the trial (from Day 0 to the end of the study). * To describe the antibody response to each dengue serotype after Dose 2, after Dose 3, and 1 and 5 years after Dose 3.
Sex: ALL
Age: 2 Years to 14 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: * Aged 2 to 14 years on the day of inclusion and resident of the site zone * Participant was in good health, based on medical history and physical examination * Assent form or informed consent form has been signed and dated by the participant (based on local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations) * Participant attended all scheduled visits and to comply with all trial procedures. Exclusion Criteria: * Participant was pregnant, or lactating, or was of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination) * Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination * Planned participation in another clinical trial during the present trial period * Self-reported 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) * Self-reported seropositivity for Human Immunodeficiency Virus (HIV) infection * Self-reported systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion * Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response * Planned receipt of any vaccine in the 4 weeks following any trial vaccination * Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily * Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures * Identified as a site employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member (i.e., immediate, husband, wife and their children, adopted or natural) of the site employees or the Investigator.
- Denpasar, Bali, Indonesia
- Bandung, West Java, Indonesia
- Jakarta, Indonesia
- Kuala Lumpur, Malaysia
- Pulau Pinang, Malaysia
- Cebu City, Philippines
- San Pablo, Philippines
- Nai Muang, Changwat Kamphaeng Phet, Thailand
- Ban Pong, Changwat Ratchaburi, Thailand
- Photharam, Changwat Ratchaburi, Thailand
- Long Xuyen, An Giang, Vietnam
- Mỹ Tho, Tien Giang Province, Vietnam