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Virus Diseases clinical trials

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NCT ID: NCT02956837 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Rank Different Dosages of Antigen of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A), Based on Their Immune Response and Safety, When Administered to Healthy Adult Women

Start date: November 10, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to rank different RSV vaccine dosages of antigen (or formulations) based on safety/reactogenicity and immune response data. The formulations eliciting strong immune responses while maintaining an acceptable safety profile will be considered for further evaluation, including in studies vaccinating pregnant women.

NCT ID: NCT02952833 Completed - Clinical trials for Zika Virus Infection

ZIKA Vaccine in Naive Subjects

Start date: October 14, 2016
Phase: Phase 1
Study type: Interventional

This study is a study to evaluate the safety of ZPIV. Three dose levels may be evaluated. The entire duration of each subject's participation is approximately 14 months including recruitment and collection of data on the safety and reactogenicity of the study vaccine and samples for the assessment of immunogenicity. This study is expected to take approximately 30 months to complete from initiation through availability of a final report on the primary outcomes of safety and the secondary outcomes of humoral immunity to ZIKV. The Primary objectives of this study are to 1. Assess the safety and reactogenicity of a homologous prime boost regimen of ZPIV given at three different dose levels and 2. Compare the safety and reactogenicity profile of ZPIV after each vaccination and between dosage groups.

NCT ID: NCT02952339 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Evaluating the Infectivity, Safety, and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine in RSV-Seronegative Infants and Children 6 to 24 Months of Age

Start date: August 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants 6 to 24 months of age. This study is a companion study to IMPAACT 2011.

NCT ID: NCT02878330 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.

MEDI8897 Ph2b
Start date: November 3, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29 and 35 weeks gestational age (GA) and entering their first Respiratory Syncytial Virus (RSV) season.

NCT ID: NCT02868242 Completed - Clinical trials for Hepatitis C Virus Infection

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy

Start date: August 28, 2016
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in pediatric participants who are undergoing cancer chemotherapy.

NCT ID: NCT02856984 Completed - Clinical trials for Zika Virus Disease (Disorder)

Zika in Infants and Pregnancy (ZIP)

Start date: June 2016
Phase:
Study type: Observational

The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP) study is to assess the strength of the association between Zika virus infection (ZIKV) during pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. The study will prospectively enroll a cohort of pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction) test. The study will follow these women through their pregnancy to identify for clinical evidence of acute ZIKV, while controlling for potential confounders. Outcomes in the women, the developing fetus, and infants will be assessed. All protocol-specified data will be recorded and entered in a central data management system for the purposes of analysis of composite data from the study.

NCT ID: NCT02847156 Completed - Cystic Fibrosis Clinical Trials

Impact of Respiratory Viral Infections in Infants With Cystic Fibrosis.

PREVIMUC
Start date: January 2015
Phase: N/A
Study type: Interventional

Respiratory Viral Infections (RVI) are particularly frequent in young children. Old data mention the deleterious role of some viruses such as the Respiratory Syncytial Virus in young children with cystic fibrosis (CF). However, recent epidemiological data on RVI in CF children are rare and the impact of most frequent viruses such as human rhinoviruses is usually not correctly evaluated. The aim of this study is to assess the frequency of lower and upper RVI during a 1 year follow-up in CF infants and to evaluate the impact of RVI at a clinical, microbiological and therapeutic level. Our hypothesis is that frequent and/or clinically severe RVIs have the worst impact in the short term and without any particular link with a specific virus as previously described.

NCT ID: NCT02831751 Completed - Clinical trials for Respiratory Tract Infections

Immunogenicity, Safety, and Tolerability of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Elderly Adults

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

This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The study is being conducted to evaluate that the immunogenicity profile of the Quadrivalent VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure criteria and to evaluate if the immunogenicity and the safety profile of the Quadrivalent VLP Vaccine is acceptable and comparable to that of the FluLaval® Tetra and Fluzone® High-Dose (HD). The study will also help to define the optimal dose in this population, establish potential competitive advantages, and support the design of future studies.

NCT ID: NCT02831699 Completed - Dengue Clinical Trials

The Evaluation of Potential Zika, Chikungunya, and Dengue Infections in Mexico

Zik01
Start date: June 21, 2016
Phase:
Study type: Observational

This study will evaluate subjects with fever and/or rash to determine the percentage of those infected by the Zika, Chikungunya, or Dengue virus. The study will also compare the clinical signs, symptoms, and lab abnormalities related to each virus, to better specify each virus's characteristics.

NCT ID: NCT02825212 Completed - Hepatitis C Clinical Trials

Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia

Start date: February 2016
Phase: Phase 2/Phase 3
Study type: Interventional

10 patients with chronic genotype 1 HCV infection and mixed cryoglobulinemia will be treated with Ledipasvir/Sofosbuvir 90mg/400 mg FDC once daily for 12 weeks (naïve subjects or non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects with cirrhosis). The researchers anticipate that approximately 20% of subjects may have cirrhosis.