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Sponsor: Sanofi Pasteur, a Sanofi Company
Conditions: Dengue Fever, Dengue Haemorrhagic Fever
Countries: Thailand
Primary objectives: * To assess how dengue vaccine efficacy varies across participant subgroups regarding polymorphism in human leukocyte antigen (HLA) alleles of interest. * To assess the association between HLA alleles and, serotype-specific neutralization antibody titers and summary neutralization measure in the vaccine and placebo groups. * To assess the association between the polymorphism in HLA alleles of interest and susceptibility to Dengue fever and Dengue Haemorrhagic fever. Secondary objectives: * To assess whether dengue serotype-specific neutralizing antibody titers and associated summary neutralization measure at 28 days post-dose 3 are related to the rate of occurrence of symptomatic Virologically-confirmed dengue infection after post-dose 3 * To evaluate whether the dengue serotype-specific neutralizing antibody and associated summary neutralization measure at 28 days post-dose 3 are related to the level of vaccine efficacy against dengue viruses after post-dose 3.
Sex: ALL
Age: 7 Years to 17 Years
Healthy volunteers: Yes
Study type: OBSERVATIONAL
Inclusion Criteria: * Subject currently enrolled in, or having recently finished, CYD57 (NCT01983553; long-term safety follow-up study of the first PoC efficacy study), included in the subjects list provided by the Sponsor, with or without past experience of virologically confirmed dengue. * For children 7 to \< 18 years. Assent form (AF) has been signed and dated by the subject, and informed consent form (ICF) has been signed and dated by the parents or another legally acceptable representative and by independent witness, as per local Ethics Committee (EC) requirement. For subjects ≥ 18 years. ICF has been signed and dated by the subject and by independent witness, as per local EC requirement. * Subject (and parent(s) / legally acceptable representative for subject \< 18 years) are able to attend the scheduled visit and can comply with all study procedures. Exclusion Criteria: * Any illness that, in the opinion of the Investigator, might interfere with study procedures.
- Ratchaburi, Thailand