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CYD Dengue Vaccine Serotypes 1

Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years

Ensayo de Sanofi en Dengue Virus · Dengue Fever · Dengue Hemorrhagic Fever · Dengue Diseases (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

300

previstos

Centros

1

Fin del objetivo primario

feb 2010

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en sep 2008.

Qué mide

Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo (Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease. Primary Objectives: * To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously vaccinated with yellow fever (YF) vaccine. * To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years). * To describe viremia after the first and second vaccinations with dengue vaccine in a subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30 participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5 years).

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00788151), actualizada en mar 2022.