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The purpose of this study is to demonstrate that different CYD Dengue vaccine lots manufactured using the same method and in the same location but at different times produce an equivalent immunological response.
- To demonstrate that three different Phase III lots of CYD Dengue vaccine induce an equivalent immune response in terms of post-Dose 3 geometric mean titers (GMTs) against the four parental serotypes.
- To demonstrate that Phase II and pooled Phase III lots of CYD Dengue vaccine induce an equivalent immune response in terms of post-Dose 3 GMTs against the four parental serotypes.
- To describe the safety (in terms of solicited injection site and systemic reactions and unsolicited adverse events) of the CYD Dengue vaccine in all subjects after each dose.
All subjects will receive 3 doses of their assigned vaccine or placebo and will provide blood samples at defined timepoints for flavivirus status and immunogenicity assessment. Reactogenicity data will be collected in all subjects after each dose and throughout the study.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus, Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus, Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus, Live, attenuated, recombinant dengue serotypes 1, 2, 3
Not yet recruiting
Published on BioPortfolio: 2014-07-24T14:01:10-0400
The purpose of this study is to investigate the potential for co-administration of the first dose of CYD Dengue vaccine with childhood vaccination. Primary Objectives: - To desc...
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Vaccines or candidate vaccines used to prevent infection with DENGUE VIRUS. These include live-attenuated, subunit, DNA, and inactivated vaccines.
A species of ENTEROVIRUS which is the causal agent of POLIOMYELITIS in humans. Three serotypes (strains) exist. Transmission is by the fecal-oral route, pharyngeal secretions, or mechanical vector (flies). Vaccines with both inactivated and live attenuated virus have proven effective in immunizing against the infection.
A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had mumps or been immunized with live mumps vaccine. Children are usually immunized with measles-mumps-rubella combination vaccine.
A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had measles or been immunized with live measles vaccine and have no serum antibodies against measles. Children are usually immunized with measles-mumps-rubella combination vaccine. (From Dorland, 28th ed)
A live, attenuated varicella virus vaccine used for immunization against chickenpox. It is recommended for children between the ages of 12 months and 13 years.
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...