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Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study

NCT01983553

CompletedN/A

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Dengue, Dengue Fever, Dengue Hemorrhagic Fever

Countries: Thailand

The purpose of this study was to conduct a passive surveillance of hospitalized dengue cases in participants who participated in study CYD23 (NCT00842530). The Objectives: * To describe the incidence of virologically-confirmed hospitalized dengue cases. * To characterize hospitalized dengue cases. * To evaluate the occurrence of related and fatal serious adverse events (SAEs).

Eligibility overview

Sex: ALL

Age: 7 Years to 16 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Ongoing participation in study CYD23 at the time of enrolment.
* Assent form was signed and dated by the participant (for participants \>= 7 years old), and informed consent form was signed and dated by the parent(s) or another legally accepted representative and by 2 independent witnesses.
* Participant and parent/legally accepted representative were able to attend all scheduled visits to comply with all study procedures.

Exclusion Criteria:

* Planned participation in another dengue clinical trial during the present study
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.

Locations (1)

Ratchaburi, Muang District, Thailand