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Dengue clinical trials

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NCT ID: NCT02678455 Completed - Dengue Clinical Trials

Safety and Immunogenicity of the Dengue Virus Vaccine TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh

Start date: March 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of the recombinant live attenuated tetravalent dengue virus vaccine admixture TV005 (TetraVax-DV T005) in healthy adults, adolescents, and children in Dhaka, Bangladesh.

NCT ID: NCT02628444 Completed - Dengue Fever Clinical Trials

Immunogenicity and Safety of Different Vaccination Schedules of Tetravalent Dengue Vaccine in Healthy Subjects 9 to 50 Years of Age

Start date: May 2, 2016
Phase: Phase 2
Study type: Interventional

The aim of the study was to assess the immune response and the safety of different vaccination schedules of CYD dengue vaccine. The primary objectives of the study were: - To demonstrate the non-inferiority of the immune response elicited against each dengue serotype by CYD dengue vaccine given as a 2-dose schedule (Group 2) compared to the immune response elicited by CYD dengue vaccine given as a 3-dose schedule (Group 1), in previously dengue exposed participants 28 days after the last injection. - To demonstrate the non-inferiority of the immune response elicited against each dengue serotype by CYD dengue vaccine given as a 2-dose schedule (Group 2) compared to the immune response elicited by CYD vaccine given as a 3-dose schedule (Group 1) in previously dengue exposed participants, 1 year after the last injection. - To demonstrate the non-inferiority of the immune response elicited against each dengue serotype elicited by a booster dose of CYD dengue vaccine one year or two years after the last injection in the primary series in previously dengue exposed participants, compared to the immune response post dose 3 in Group 1. The secondary objectives of the study were: - To demonstrate the superiority of the immune response elicited by CYD dengue vaccine given as a 2-dose schedule (Group 2) compared to the immune response elicited by CYD dengue vaccine given as a 3-dose schedule (Group 1), in previously dengue exposed participants, 28 days after the last injection. - To demonstrate the superiority of the immune response elicited by CYD dengue vaccine given as a 2-dose schedule (Group 2) compared to the immune response elicited by CYD dengue vaccine given as a 3-dose schedule (Group 1), in previously dengue exposed participants, one year after the last injection. - To describe the neutralizing antibody levels of each dengue serotype at 28 days post-injection 3 to the antibody levels immediately before receiving a booster dose, by baseline dengue serostatus. - To describe the neutralizing antibody levels of each dengue serotype at 28 days post-injection 2 and 28 days post-injection 3 from Group 1 in a primary series schedule by baseline dengue serostatus. - To demonstrate the superiority of the immune response elicited against each dengue serotype 28 days after administration of a booster dose of CYD dengue vaccine, in previously dengue exposed participants, at one year or two years after last injection in the primary series. - To describe the seroconversion rate 28 days post-booster injection in all 3 groups. - To describe all hospitalized virologically confirmed dengue (VCD) cases during the study. - To evaluate the safety profile of CYD after each and any injection during the trial. Safety assessments include solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period.

NCT ID: NCT02623725 Completed - Dengue Fever Clinical Trials

Study of a Booster Dose of a Tetravalent Dengue Vaccine in Subjects Who Previously Completed the 3-dose Schedule

Start date: April 14, 2016
Phase: Phase 2
Study type: Interventional

The aim of the study was to assess and describe the booster effect of a CYD dengue vaccine dose administered 4 to 5 years after the completion of a 3-dose vaccination schedule. Primary Objective - To demonstrate the non-inferiority, in terms of geometric mean of titer ratios (GMTRs), of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD13 - NCT00993447 and CYD30 - NCT01187433 trials (participants from Group 1 only). Secondary Objectives: - If the primary objective of non-inferiority was achieved: To demonstrate the superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD13 and CYD30 trials. - To describe the immune responses elicited by a CYD dengue vaccine booster and placebo injection in participants who received 3 doses of the CYD dengue vaccine in the CYD13 and CYD30 trials in all participants. - To describe the neutralizing antibody levels of each dengue serotype post-dose 3 (CYD13 and CYD30 participants) and immediately prior to booster or placebo injection in all participants. - To describe the neutralizing antibody persistence 6 months, 1 year, and 2 years post booster or placebo injection in all participants. - To evaluate the safety of booster vaccination with the CYD dengue vaccine in all participants.

NCT ID: NCT02570152 Completed - Dengue Clinical Trials

A Cohort Study to Determine the Incidence of Dengue Fever and to Build Capacity for Dengue Vaccine Trials in Dengue-endemic Regions of South Asia

Start date: June 1, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the incidence of dengue fever and to build capacity for dengue vaccine trials in dengue-endemic regions of South Asia.

NCT ID: NCT02510690 Completed - Dengue Fever Clinical Trials

Factors Associated With Poor Dengue Outcomes in Malaysia

Start date: October 2014
Phase: N/A
Study type: Observational

This study aims to analyse the results of national data collected by the e-Dengue Information System in order to determine the factors associated with disease outcomes in all patients registered from January 2013 to December 2014.

NCT ID: NCT02510638 Completed - Dengue Fever Clinical Trials

The Clinical Epidemiology of Hospitalized Dengue Cases in Malaysia

Start date: September 2015
Phase: N/A
Study type: Observational

Dengue infection has been identified as the fastest spreading mosquito-borne viral disease by World Health Organization (WHO), which affects more than 2.5 billion people living in the subtropical and tropical regions. Malaysia is hyper-endemic with all four dengue virus serotypes circulating and responsible for the escalating number of cases over the years. As of 28 February 2015, there are 62 deaths secondary to dengue infection being reported in Malaysia; and the total number of dengue cases reported in the same period was 23,966 which is 46% higher than the same reporting period of 2014. Although dengue virus has been identified for so many years and plenty of research work has been carried out, it was proven that there are still many aspects that we are not too sure about the disease. Therefore, this multi-center, observational cohort study is designed to investigate the clinical course of hospitalized dengue infection in Malaysia. The study population of this study consists of male or female patients with dengue to be randomly sampled from hospitals in Malaysia. This study will be conducted in 2 stages whereby the 1st stage will only focus on the basic social and clinical data to describe the clinical course of dengue as general and the 2nd stage will collect the more detailed clinical and management data to describe the detailed clinical course, management and prognosis of dengue. All hospital participation in this study is voluntary, and approval will be obtained from National Institute of Health (NIH) and Medical Research Ethics Committee (MREC) prior to any recruitment.

NCT ID: NCT02450838 Completed - Dengue Clinical Trials

Evaluating the Safety, Tolerability, and Immunogenicity of a Tetravalent Dengue Vaccine (V180) in Healthy Adults Who Previously Received a Live-Attenuated Tetravalent Vaccine (TV003 or TV005)

Start date: April 2015
Phase: Phase 1
Study type: Interventional

Dengue viruses are mosquito-borne flaviviruses. Each year, dengue viruses infect millions of people throughout the tropics and subtropics. This study will evaluate the safety, tolerability, and immunogenicity of a tetravalent recombinant subunit dengue vaccine (V180) in healthy adults who previously received a live-attenuated tetravalent dengue vaccine (TV003 or TV005).

NCT ID: NCT02433652 Completed - Dengue Clinical Trials

Evaluating the Safety and Protective Efficacy of a Single Dose of a Trivalent Live Attenuated Dengue Vaccine to Protect Against Infection With DENV-2

Start date: September 2015
Phase: Phase 1
Study type: Interventional

Infection with dengue viruses is the leading cause of hospitalization and death in children in many tropical Asian countries, and the development of a dengue vaccine is a top health priority. This study will evaluate the ability of a single dose of a trivalent dengue vaccine to protect against infection with an attenuated candidate DENV-2 vaccine, administered 6 months after the trivalent dengue vaccine.

NCT ID: NCT02425098 Completed - Dengue Fever Clinical Trials

Safety and Immunogenicity With Two Different Serotype 2 Potencies of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Adults in Singapore

Start date: June 3, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the post-vaccination neutralizing antibody response against each dengue serotype by vaccine group.

NCT ID: NCT02421367 Completed - Dengue Clinical Trials

Study of Varying Injection Schedules of TDENV-PIV Vaccine With AS03B Adjuvant and Placebo in Healthy US Adults

Start date: August 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This study is being conducted to evaluate the safety and immunogenicity and antibody persistence of the candidate dengue vaccine.