A Phase I/II Trial of a Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naïve Children

NCT00384670 Phase 1/Phase 2 COMPLETED Results posted

To assess the safety, reactogenicity and immunogenicity of two doses of the dengue vaccine in Flavi-virus antibody-naive children between 6 and 9 years of age.

Details

Lead sponsor	U.S. Army Medical Research and Development Command
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	7
Start date	2003-08
Completion	2004-05

Conditions

• Dengue Fever

Interventions

• Dengue Vaccine Formulation 17
• Licensed Japanese Encephalitis (JE) Vaccine

Primary outcomes

• Number of Solicited Adverse Events Within 21 Days After the First Dose of Dengue Vaccine. — 21 days
  Number of solicited general symptoms within the 21-day follow-up after dengue dose 1 (total vaccinated cohort).

Countries

Thailand