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Meningitis, Meningococcal clinical trials

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NCT ID: NCT01889836 Completed - Clinical trials for Meningitis, Meningococcal, Serogroup C

Safety and Immunogenicity Study in Young Adults the Meningococcal Serogroup C Vaccine Produced by Bio-Manguinhos

Start date: May 2014
Phase: Phase 1
Study type: Interventional

Clinical trial phase I, randomized, double blind, where 30 individuals will receive the experimental vaccine while 30 other volunteers will receive a meningococcal C conjugate vaccine already licensed in Brazil and available in the National Immunization Program for children less than 12 months of age. The primary outcome of the study is to evaluate the safety profile of the vaccine under test, which should allow its application in humans. Secondly, the investigators will study its immunogenicity from the evaluation of the correlates of seroprotection for meningococcal, defined by the World Health Organization (WHO).

NCT ID: NCT01768117 Completed - Clinical trials for Meningitis, Meningococcal, Serogroup B

Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age

B1971042
Start date: February 2013
Phase: Phase 2
Study type: Interventional

This study will assess the safety, tolerability and immunogenicity of bivalent rLP2086 vaccine in laboratory workers ≥18 to ≤65 years of age administered on a Month 0, 2, and 6 schedule. The study will recruit laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development program. The study will provide descriptive safety and immunogenicity data following vaccination of these individuals with bivalent rLP2086 vaccine.

NCT ID: NCT01732627 Completed - Meningitis Clinical Trials

Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older

Start date: November 12, 2012
Phase: Phase 2
Study type: Interventional

Primary objectives: - To describe the antibody responses to meningococcal serogroups A, C, Y, and W 135, measured by serum bactericidal assay using human complement (hSBA) and baby rabbit complement (rSBA), induced by a single dose of Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein (MenACYW) Conjugate vaccine or Menomune® - A/C/Y/W 135. - To describe the safety profile of a single dose of MenACYW Conjugate vaccine or Menomune® - A/C/Y/W 135.

NCT ID: NCT01717638 Completed - Clinical trials for Meningococcal Disease

Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1

Start date: November 2012
Phase: Phase 3
Study type: Interventional

It is a Phase 3 extension of study V72P12E1 (NCT00944034). The main aim of the second extension study is to explore the bactericidal antibody persistence in 4-year-old children after a fourth dose boost of rMenB+OMV NZ or after a two-dose catch-up schedule of rMenB+OMV NZ administered to toddlers as part of their respective vaccination courses in study V72P12E1. In addition, this study will characterize the antibody response to a fifth dose boost in all children who received a three-dose primary series of rMenB+OMV NZ at 2, 3, 4 months of age (in parent study V72P12, NCT00721396), and only in a subset of children who received a three-dose primary series of rMenB+OMV NZ at 2, 4, 6 months of age (in parent study V72P12). Antibody response will also be characterized to a third dose boost of rMenB+OMV NZ administered at approximately 4 years of age in all children who received a two catch-up doses of rMenB+OMV NZ as toddlers in study V72P12E1. Finally, the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ administered 2 months apart to healthy naïve children at 4 years of age will be assessed.

NCT ID: NCT01519713 Completed - Meningitis Clinical Trials

Study of a Single Dose of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects

Start date: January 2012
Phase: Phase 3
Study type: Interventional

This study is designed to assess the safety and immunogenicity of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) to support registration of the product in Japan. Primary Objective: - To describe the seroprotection rate [% of subjects with serum bactericidal assay using baby rabbit complement (SBA-BR) ≥1:128] to meningococcal antigens (serogroups A, C, Y and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age Secondary Objectives: - To describe the safety following receipt of SP284 vaccine in subjects 2 through 55 years of age - To describe the immune responses to meningococcal antigens (serogroups A, C, Y and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age.

NCT ID: NCT01482052 Completed - Clinical trials for Meningococcal Meningitis

Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis

Start date: November 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety of a new conjugate vaccine, NmVac4-A/C/Y/W-135-DT, compared to the safety of a similar, licensed meningococcal A/C/Y/W-135-DT conjugate vaccine. The investigators will also evaluate the production of antibodies to of NmVac4-A/C/Y/W-135-DT™ conjugate vaccine compared to the licensed vaccine, as a measure of vaccine effectiveness.

NCT ID: NCT01478347 Completed - Clinical trials for Meningococcal Disease

A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults

Start date: May 2013
Phase: Phase 3
Study type: Interventional

The proposed study will evaluate the safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers). In the second part of the study additional blood samples of high responding vaccinated subjects will be collected for the purpose of generating a control serum panel for the human serum bactericidal assay (hSBA) tests.

NCT ID: NCT01466387 Completed - Clinical trials for Meningococcal Disease

A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults

Start date: November 2011
Phase: Phase 3
Study type: Interventional

This study compares the safety and immunogenicity profile of several travel vaccines given alone or concomitantly with MenACWY-CRM to healthy adults.

NCT ID: NCT01453348 Completed - Hepatitis B Clinical Trials

Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine

Start date: October 2011
Phase: Phase 3
Study type: Interventional

This study compares the safety and immunogenicity profile of combined hepatitis A/B vaccine given alone or concomitantly with MenACWY-CRM to healthy adults.

NCT ID: NCT01434680 Completed - Clinical trials for Meningococcal Disease

Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers

Start date: September 2011
Phase: Phase 2
Study type: Interventional

The study was to evaluate the safety and and immune response of each of three lots of Novartis Meningococcal C Conjugate Vaccine (MenC-CRM Liquid) when administered to Healthy Toddlers.