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Herpes Zoster clinical trials

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NCT ID: NCT00568334 Completed - Varicella Clinical Trials

Study of Two Formulations of GSK Biologicals' Varicella Vaccine

Start date: November 1, 2007
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate a modified formulation of GSK Biologicals' live attenuated varicella vaccine. In vivo pre-clinical data show this change has no negative impact on vaccine safety. This present study is undertaken to rule out any negative impact on the immunogenicity and safety of GSK Biologicals' live attenuated varicella virus vaccine.

NCT ID: NCT00561080 Completed - Clinical trials for Prevention of : Herpes-Zoster

Immunogenicity and Safety of a 1-dose Regimen of a Zoster Vaccine Versus Different 2-dose Regimens in Participants ≥ 70 Years of Age. (V211-043)

Start date: October 26, 2007
Phase: Phase 3
Study type: Interventional

Primary objective: Immunogenicity To demonstrate that a second dose of ZOSTAVAX® elicits higher varicella-zoster virus (VZV) antibody titres than a first dose of ZOSTAVAX® whether given as a 0-1 month schedule or as a 0-3 month schedule in subjects ≥70 years of age as measured at 4 weeks post-vaccination Secondary objectives Immunogenicity - To summarise the VZV antibody titres at 4 weeks post-vaccination after a 1-dose regimen and 4 weeks post-vaccination after each dose of each 2-doses regimen of ZOSTAVAX®. - To compare the VZV antibody titres at 12 months after completion of a 1-dose regimen with the VZV antibody titres at 12 months after completion of each 2-doses regimen of ZOSTAVAX® - To summarise the VZV antibody titres at 24 and 36 months after completion of a 1-dose regimen and at 24 and 36 months after completion of each 2-doses regimen of ZOSTAVAX®

NCT ID: NCT00560755 Completed - Measles Clinical Trials

Safety Study of ProQuad® rHA in Infants (V221-037)

Start date: October 24, 2007
Phase: Phase 3
Study type: Interventional

Primary objective: To describe the safety profile of a second dose of ProQuad® manufactured with recombinant human albumin (rHA) when administered to children in their second year of life. Secondary objectives: To describe the safety profile of a first dose of ProQuad® manufactured with rHA when administered to children in their second year of life.

NCT ID: NCT00550745 Completed - Herpes Zoster Clinical Trials

ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)

Start date: September 2007
Phase: Phase 4
Study type: Interventional

The purpose of the study is to evaluate the general safety of ZOSTAVAX™ in subjects 60 years of age or older as required by the FDA.

NCT ID: NCT00546819 Completed - Herpes Zoster Clinical Trials

ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids (V211-017) (COMPLETED)

Start date: October 2007
Phase: Phase 2
Study type: Interventional

The purpose of the study was to assess the safety, tolerability, and immunogenicity of ZOSTAVAX™ in patients receiving chronic/maintenance corticosteroids.

NCT ID: NCT00535730 Completed - Herpes Zoster Clinical Trials

ZOSTAVAX™ Administered Concomitantly With PNEUMOVAX™ 23 (V211-012)(COMPLETED)

Start date: June 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Zoster Vaccine Live and Pneumococcal Vaccine, polyvalent are as well tolerated and immunogenic when the vaccines are given together (in different body sites), as when they are given alone, in adults 60 years of age and older.

NCT ID: NCT00535236 Completed - Herpes Zoster Clinical Trials

A Study of an Investigational V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults (V212-002)

Start date: November 2, 2007
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety and immunogenicity of a heat-treated VZV vaccine in autologous or allogeneic hematopoietic cell transplant (HCT) recipients, human immunodeficiency virus (HIV)-infected participants with a baseline cluster of differentiation 4 (CD4) cell count ≤200 cells/mm^3, participants with solid tumor malignancy (STM; breast, colorectal, lung, or ovarian malignancies) receiving chemotherapy, and participants with hematologic malignancy (HM; leukemia or leukemia-like disease, lymphoma or lymphoma-like disease, or multiple myeloma). The primary hypothesis is that the heat-treated VZV vaccine will elicit significant VZV-specific immune responses measured by either glycoprotein-based enzyme-linked immunosorbent assay (gpELISA) or VZV gamma interferon enzyme-linked immunospot (IFN-ELISPOT) at 28 days post dose vaccination 4 in, HIV-infected participants, participants with STM, and participants with HM. The primary immunogenicity objective and endpoints were considered by the protocol as exploratory for the autologous and allogeneic HCT groups.

NCT ID: NCT00526864 Completed - Herpes Zoster Clinical Trials

Measuring Herpes Zoster and PHN Associated Burden of Illness and Health Care Utilization Costs in Thailand

Start date: May 2007
Phase: N/A
Study type: Observational

Total 7 institutions will be recruited i.e. Clinical Infectious Disease Research Unit Department of Clinical Tropical Medicine, Faculty of Tropical Medicine Mahidol University,Bamrasnaradura Infectious Disease Institute ,Pramonkutklao Hospital,Rajavithi Hospital,NationalCancerInstitute,Institute of Dermatology,Raj Pracha Samasai Institute OBJECTIVES - Measure the burden of illness due to herpes zoster (Zoster) and post-herpetic neuralgia (PHN) (severity and duration); - Assess the quality of life (QoL) and quality adjusted life years (QALY) lost due to Zoster and PHN; - Describe health care resource utilization associated with Zoster and PHN; - Describe the direct and indirect costs per case of Zoster and PHN

NCT ID: NCT00501670 Completed - Herpes Zoster Clinical Trials

VZV PCR Sampling Validation Study

Start date: August 2007
Phase: N/A
Study type: Observational

This study will evaluate and compare various methods for collecting lesion samples from subjects with clinically diagnosed herpes zoster for the laboratory confirmation of herpes zoster. The samples will be tested by polymerase chain reaction (PCR) to detect VZV DNA. Multiple samples from each type of herpes zoster lesion will be collected in order to determine whether the analysis of duplicate samples enhances the sensitivity of VZV DNA detection for the diagnosis of herpes zoster. In addition, blood will be collected for the evaluation of VZV immunity at the time of the initial herpes zoster sample collection (after herpes zoster has been clinically diagnosed) and one month later in order to establish the range of cellular and humoral immune responses during natural herpes zoster in adults ≥50 years old.

NCT ID: NCT00492648 Completed - Herpes Zoster Clinical Trials

Month 30 & 42 Extension Studies of CRD-004 Primary Study

Start date: June 25, 2007
Phase: Phase 2
Study type: Interventional

The safety and immunogenicity of the GSK324332A vaccine has been evaluated up to Month 12 post-vaccination in the primary study. In the extension studies presented here, the persistence of the cellular and humoral immune responses will be evaluated 30 and 42 months after the first vaccination in young and elderly adults who received the GSK324332A vaccine. This protocol posting deals only with objectives & outcome measures of the extension phase at Months 30 and 42. No new recruitment will be done in these extension phases of the primary study. No vaccines are administered in this phase of the study.