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Dengue Fever clinical trials

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NCT ID: NCT02193087 Completed - Dengue Fever Clinical Trials

Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV)

Start date: August 6, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the equivalence of the lyophilized formulation of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) compared with the liquid formulation of TDV.

NCT ID: NCT01983553 Completed - Dengue Clinical Trials

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

Start date: September 10, 2013
Phase:
Study type: Observational

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).

NCT ID: NCT01943825 Completed - Dengue Clinical Trials

Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity After CYD Tetravalent Dengue Vaccine

Start date: November 5, 2013
Phase: Phase 2
Study type: Interventional

The aim of the study was to evaluate a compressed dosing schedule and the immunologic effects of co-administration of a CYD dengue vaccine with a licensed flavivirus (FV) with Japanese encephalitis (JE) vaccine. Primary Objectives: - To describe and compare the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each CYD dengue vaccine dose. - To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes 6 after CYD dengue vaccine Dose 3, irrespective of whether or not JE vaccine had been previously administered. Secondary Objectives: - To describe the safety profile after each injection of CYD dengue vaccine. - To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each CYD dengue vaccine dose when administered with or after JE virus vaccine in Groups 3 and 4. - To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes at 6 months post-dose 3 in all four groups and at 12 months post-dose 3 in Groups 1 and 3 with the compressed schedule. - To determine the level of viremia on Day (D)0, D3, D5, D7 and D14 following each CYD vaccine dose administered in Groups 1-4. - To describe the JE humoral immune response at baseline and 28 days after each injection of CYD dengue vaccine in Groups 3 and 4.

NCT ID: NCT01917422 Completed - Dengue Fever Clinical Trials

Clinical Specimens Testing Program of Dengue Antigen Detection Reagents

Start date: July 2012
Phase: N/A
Study type: Observational

Dengue virus serological reagent, included antigen and antiserum, is a serum test for identification of serum antibodies to dengue virus.

NCT ID: NCT01728792 Completed - Dengue Fever Clinical Trials

Impact of SC vs IM Administration of DENVax (TDV) on Safety and Immunogenicity

Start date: January 22, 2013
Phase: Phase 1
Study type: Interventional

This study assessed the safety and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) previously referred to as DENVax of various dosing schedules via subcutaneous (SC) or intramuscular (IM) administration with needle/syringe or needle-free injector (PharmaJet Stratis™).

NCT ID: NCT01702857 Completed - Dengue Fever Clinical Trials

A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults (in Puerto Rico)

DPIV-002
Start date: November 2012
Phase: Phase 1
Study type: Interventional

This is a first time in humans (FTiH) study designed to assess the experimental TDENV-PIV vaccine in a predominantly dengue-primed adult population. The study is designed to afford a first time in humans (FTiH) safety and immunogenicity assessment of three TDENV-PIV vaccine candidates, each formulated with a different adjuvant: either aluminum hydroxide, AS01E or AS03B (adjuvants used in GSK Biologicals' hepatitis B candidate vaccine, malaria candidate vaccine and pandemic flu vaccine, respectively). Each vaccine candidate will contain 1 µg of purified virus antigen per each of the four DENV types. Additionally, the study will evaluate an alum adjuvanted TDENV-PIV vaccine candidate containing 4 µg of purified virus antigen per each of the four DENV types. The control group will receive a saline placebo. All experimental vaccinations will be administered according to a 2-dose schedule, 28 days apart. There is a parallel FTiH study that is conducted in the United States in a dengue-naive population using the same investigational vaccines.

NCT ID: NCT01666652 Completed - Dengue Fever Clinical Trials

A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults

DPIV-001
Start date: September 2012
Phase: Phase 1
Study type: Interventional

The study is designed to afford a safety and immunogenicity assessment of three Tetravalent Dengue Virus-Purified Inactivated Vaccine(TDENV-PIV) vaccine candidates.

NCT ID: NCT01619969 Completed - Dengue Fever Clinical Trials

Celgosivir as a Treatment Against Dengue

CELADEN
Start date: July 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study to Evaluate the Activity, Pharmacokinetics, Safety and Tolerability of Celgosivir in Adults with Confirmed Dengue Fever.

NCT ID: NCT01550289 Completed - Dengue Clinical Trials

Study of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India

Start date: March 2012
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine in India adult subjects. Primary Objectives: - To describe the neutralizing antibody response to each dengue virus serotype before the first vaccination and after each vaccination with CYD dengue vaccine in all subjects. - To describe the safety of the CYD dengue vaccine after each dose in all subjects. Secondary Objective: - To detect symptomatic dengue cases occurring at any time in the trial.

NCT ID: NCT01550016 Completed - Dengue Fever Clinical Trials

International Research Consortium on Dengue Risk Assessment, Management, and Surveillance

IDAMS
Start date: October 2011
Phase: N/A
Study type: Observational

Improvements in diagnosis of dengue fever and prediction of which patients will get more severe disease are urgently needed to improve the treatment of patients with dengue. This is very important in places with many people who suffer from dengue but have limited health care resources. This study will enroll patients with fever which may be caused by dengue in 6 countries with high incidence of dengue over two continents (Brazil, Cambodia, El Salvador, Indonesia, Malaysia and Vietnam). All patients will be followed by a doctor with blood tests and exams until they recover. Symptoms and laboratory tests will be followed so that the cause of fever can be determined. For patients who have dengue, the investigators will look for symptoms and tests which indicate more serious disease. This study will help to determine how to identify patients with dengue fever based on symptoms and simple laboratory tests and those who will get more serious disease. It will also help to define a more standardized management of patients with dengue fever.