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Meningococcal Infections clinical trials

View clinical trials related to Meningococcal Infections.

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NCT ID: NCT01359449 Completed - Meningitis Clinical Trials

Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine Immunizations

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

The purpose for this study is to demonstrate the safety and immunogenicity of two doses of Menactra® administered between 12 and 18 months of age and concomitantly with routine immunization with two different provincial schedule Primary Objectives: - To describe the immunogenicity of Menactra® administered concomitantly with routine immunizations at 12 and 18 months in naïve or Menjugate-primed (MenC-primed) infants (measured by serum bactericidal assay using baby rabbit complement [SBA-BR]) - To describe the immunogenicity of MenC administered concomitantly with routine immunizations at 12 months of age (measured by SBA-BR) Secondary Objectives: Safety - To describe the safety profile of Menactra® and MenC vaccines after each dose when given concomitantly with routine immunization. Immunogenicity - To describe the immunogenicity of both vaccines using serum bactericidal assay using human complement [SBA-HC] - To describe the immunogenicity of Pediacel administered at 18 months.

NCT ID: NCT01345721 Completed - Clinical trials for Meningococcal Disease

Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine

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

The primary purpose of this study is to evaluate the persistence of bactericidal antibodies in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study (NCT00667602) who received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine. This is measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against Neisseria meningitidis serogroups A, C, W-135, and Y. In addition the response one month post an additional dose of Novartis MenACWY will be measured by percentage of subjects with hSBA titers ≥ 1:8 and GMTs.

NCT ID: NCT01340898 Completed - Clinical trials for Meningococcal Infection

Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers

Start date: January 27, 2012
Phase: Phase 3
Study type: Interventional

This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 in healthy infants, when co-administered with other infant vaccines, on three different dose schedules.

NCT ID: NCT01339923 Completed - Clinical trials for Meningococcal Disease

A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years

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

The proposed study is aimed at assessing the safety and immunogenicity of rMenB+OMV NZ when administered alone without routine infant vaccines to healthy infants in their first year of life according to different two and three dose immunization schedules, which are suitable to be adopted by various national programs. This study will also investigate antibody persistence post primary series and administration of a subsequent booster dose of rMenB+OMV NZ at 11 months of age. In addition, this study will assess the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ when administered to healthy children 2 to 10 years of age. This study will also evaluate the safety and immunogenicity of the concomitant administration of rMenB+OMV NZ with meningococcal C conjugate vaccine (MenC-CRM) according to a 3, 5 and 12-month schedule.

NCT ID: NCT01274897 Completed - Clinical trials for Meningococcal Disease

A Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of MenACWY in Adolescents and Adults in Korea

Start date: December 2010
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the immunogenicity and the safety of a quadrivalent vaccine MenACWY-CRM in healthy subjects from 11 to 55 years of age in Korea.

NCT ID: NCT01272180 Completed - Clinical trials for Invasive Meningococcal Disease

Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults

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

This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines

NCT ID: NCT01270503 Completed - Meningitis Clinical Trials

Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines

Start date: December 2010
Phase: Phase 4
Study type: Interventional

This aim of the study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines. Primary Objective: To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine.

NCT ID: NCT01266993 Completed - Clinical trials for Infections, Meningococcal

Persistence and Booster Study of GSK Biologicals' Meningococcal Vaccine (GSK134612) in Healthy Children

Start date: January 3, 2011
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the persistence of the immune response of GSK134612 vaccine up to 68 months after vaccination in the primary vaccination study (NCT number = NCT00674583) of 2 to 10 year old subjects. This study will also evaluate the safety and immunogenicity of a booster dose of GSK134612 vaccine subjects who were primed in the primary vaccination study with either GSK134612 vaccine or Menjugate®. This protocol posting deals with objectives & outcome measures of the persistence and booster epochs. The objectives & outcome measures of the primary epoch are presented in a separate protocol posting (NCT number = NCT00674583)

NCT ID: NCT01239043 Completed - Meningitis Clinical Trials

Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination

Start date: November 2010
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to describe antibody persistence and response to re-vaccination with either Menactra® or Menomune® vaccine approximately three years following initial vaccination in adults who participated in trial MTA29 (NCT00874549). Objectives: - To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination. - To evaluate persistence of serum bactericidal antibodies in subjects who received Menactra® or Menomune® vaccine approximately three years ago. - To evaluate the immune response to serogroups A, C, Y, and W-135 in subjects re-vaccinated with either Menactra® or Menomune® vaccine.

NCT ID: NCT01235975 Completed - Clinical trials for Infections, Meningococcal

Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years

Start date: November 30, 2010
Phase: Phase 3
Study type: Interventional

This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 given as single dose to healthy adults 56 years or older compared to the meningococcal polysaccharide vaccine MencevaxACWYTM.