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Meningitis clinical trials

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NCT ID: NCT00474526 Completed - Clinical trials for Meningitis, Meningococcal

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants

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

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.

NCT ID: NCT00474487 Completed - Clinical trials for Meningococcal Meningitis

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults

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

This study will evaluate the safety and immune response of Novartis Meningococcal ACWY conjugate vaccine in healthy adolescents and adults.

NCT ID: NCT00459316 Completed - HIV Infections Clinical Trials

Safety of and Immune Response to a Meningitis Vaccine in HIV-Infected Children and Youth

Start date: June 2007
Phase: Phase 1/Phase 2
Study type: Interventional

Bacterial meningitis infection is common in youth 2 to 24 years of age in the United States. This disease can be treated by antibiotics, but mortality rates associated with meningitis of up to 53% have been estimated. Vaccination against meningitis may be effective in preventing this disease, especially for HIV-infected youth who have weakened immune systems. The purpose of this study was to determine the safety of and immune response to a preventive meningitis vaccine in HIV-infected youth.

NCT ID: NCT00450437 Completed - Clinical trials for Meningococcal Meningitis

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults

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

This study will evaluate the lot to lot consistency, safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.

NCT ID: NCT00443846 Completed - Clinical trials for Meningitis, Meningococcal

RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)

Start date: February 13, 2007
Phase: Phase 3
Study type: Interventional

Primary objective: To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine. The hypothesis tested is that the seroprotection rate for MMC at 28 days after the second MCC vaccination with concomitant administration of RotaTeq® is non-inferior to that without non-concomitant (sequential) administration of RotaTeq®.

NCT ID: NCT00433719 Active, not recruiting - HIV Infections Clinical Trials

Immediate Versus Deferred Antiretroviral Therapy for HIV-Associated Tuberculous Meningitis

Start date: September 2005
Phase: N/A
Study type: Interventional

The optimal time to initiate antiretroviral therapy (ART) in HIV-associated tuberculous meningitis (TBM) unknown. There are concerns that immediate ART may worsen rather than improve outcome, because drug interactiond and toxicities or development of an intracerebral immune reconstitution inflammatory syndrome (IRIS). Conversely, delaying ART may result in increased HIV-related deaths. To answer this question, we are conducting a randomised, double-blind placebo-controlled trial comparing immediate and deferred ART in HIV-infected patients presenting with TBM, to assess effect on survival.

NCT ID: NCT00428051 Terminated - Sepsis Clinical Trials

Colombia Epidemiologic Surveillance Study

LEAP II
Start date: September 2006
Phase: N/A
Study type: Observational

The study will determine the reduction in invasive pneumococcal disease (IPD) after the introduction of a National Immunization Program with PCV-7 in Bogota. The original LEAP study determine incidence of IPD prior to introduction of PCV-7 in Brazil, Costa Rica and Colombia. LEAP II is the continuation of the study in Colombia only.

NCT ID: NCT00427076 Completed - Sepsis Clinical Trials

Cotrimoxazole Versus Vancomycin for Invasive Methicillin-resistant Staphylococcus Aureus Infections

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

Methicillin-resistant Staphylococcus aureus (SA) is a major pathogen causing mainly health-care associated infections and, lately, also community acquired infections. Few treatment choices exist to treat these infections. The currently recommended antibiotics for these infections are glycopeptides (vancomycin or teicoplanin). Glycopeptide treatment hs several disadvantages. It is a last resort antibiotic family that should be reserved for the future; Vancomycin is less effective that beta-lactam drugs for SA infections susceptible to both agents; treatment can only be given intravenously; and use of vancomycin has led to the development of SA strains with partial or complete resistance to vancomycin. Cotrimoxazole is an old antibiotic active against most strains of MRSA, depending on local epidemiology. Study hypothesis: The purpose of this study is to show that cotrimoxazole is as effective as treatment with vancomycin for invasive MRSA infections. We plan a randomized controlled trial comparing treatment with cotrimoxazole vs. vancomycin for invasive MRSA infections. The primary efficacy outcome we will assess will be Improvement or cure with or without antibiotic modifications, defined as: survival at 7 days post randomization with resolution of fever (<38 for two consecutive days) and resolution of hypotension (>90 systolic without need for vasopressor support); and physician's assessment that the primary infection was improved or cured. The primary safety outcome will be all-cause 30-day survival.

NCT ID: NCT00422292 Completed - Measles Clinical Trials

Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers

Start date: December 2006
Phase: Phase 3
Study type: Interventional

This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers. Primary Objectives: - To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella (MMRV) vaccine when administered alone or concomitantly with Menactra vaccine. - To evaluate the antibody responses induced by Pneumococcal Conjugated Vaccine (PCV) when administered alone or concomitantly with Menactra vaccine. Observational Objectives: Safety - To describe the safety profile throughout the course of the study from Day 0 up to 6 months after the last study vaccination[s]) in subjects in the study groups. Immunogenicity: - To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days after the first and second Menactra vaccine administration in a subset of subjects in the first study group.

NCT ID: NCT00384397 Completed - Measles Clinical Trials

A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers

Start date: September 2006
Phase: Phase 3
Study type: Interventional

This is a Phase III, modified single-blind, randomized, parallel-group, multicenter, comparative trial in the United States designed to evaluate the immunogenicity and safety of two doses of Menactra vaccine administered alone, and concomitantly with other routine pediatric vaccines typically administered between 12 and 15 months of age. Primary Objective: To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135. Secondary Objectives: Immunogenicity - To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines. - To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with PCV vaccine. Safety - To describe the safety profile within 7 and 30 days of each vaccination, and serious adverse events (SAEs) throughout the course of the study.