Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of two different formulations of an investigational dengue vaccine (T-DEN) against a placebo vaccine when two doses are given six months apart to adults and children.


Clinical Trial Description

In this study, children and adults at multiple sites in Puerto Rico will be randomly allocated to receive one of two T-DEN formulations or placebo. Subjects will be stratified by age group (a specific number of subjects in each of 4 age groups [12 months to 50 years of age] will be enrolled). The study includes 6 scheduled visits and 4 scheduled venipunctures. Safety follow-up for dengue may require unscheduled visits and venipunctures.

> Multiple DEN virus serotypes are endemic in Puerto Rico and all residents are considered to be at risk for dengue. The results of this phase II study will provide a basis for identifying the vaccine formulations which elicit neutralizing antibodies to all four dengue virus serotypes in a high proportion of vaccine recipients. The most immunogenic and well tolerated candidate formulation identified in this study will be considered for advancement to phase III development.

> ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00468858
Study type Interventional
Source U.S. Army Medical Research and Materiel Command
Contact
Status Completed
Phase Phase 2
Start date July 2007
Completion date April 2010

See also
  Status Clinical Trial Phase
Recruiting NCT04514107 - A Cluster-randomized Trial to EValuate the Efficacy of Wolbachia-InfecTed Aedes Aegypti Mosquitoes in Reducing the Incidence of Arboviral Infection in Brazil (EVITA Dengue) N/A
Completed NCT00788151 - Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years Phase 2
Completed NCT02510638 - The Clinical Epidemiology of Hospitalized Dengue Cases in Malaysia N/A
Completed NCT01666652 - A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults Phase 1
Completed NCT01477671 - Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children N/A
Completed NCT01443247 - Role of Andi-d in Dengue Fever: a Pilot Study N/A
Completed NCT00831012 - Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3delta30/31‐7164) in Healthy Adults Phase 1
Completed NCT00089908 - Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) in Healthy Adults Phase 1
Completed NCT01983553 - Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study
Completed NCT01134263 - Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia Phase 3
Completed NCT02741128 - Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults Phase 2
Completed NCT03620487 - Detection of Dengue Virus in Plasma of Patients in Nepal
Recruiting NCT02608047 - Studies on the Pathogen, Vector Control and Clinical Treatment of Dengue Fever in Guangzhou N/A
Completed NCT02510690 - Factors Associated With Poor Dengue Outcomes in Malaysia N/A
Completed NCT01550016 - International Research Consortium on Dengue Risk Assessment, Management, and Surveillance N/A
Completed NCT01421732 - Laboratory Diagnosis and Prognosis of Severe Dengue N/A
Completed NCT00993447 - Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America Phase 2
Completed NCT01224639 - Safety and Immunogenicity Study to Assess TDV, a Live Attenuated Tetravalent Vaccine for Prevention of Dengue Fever Phase 1
Completed NCT01943825 - Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity After CYD Tetravalent Dengue Vaccine Phase 2
Active, not recruiting NCT03465254 - Dengue Serostatus Study in the Philippines