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Meningococcal Disease clinical trials

View clinical trials related to Meningococcal Disease.

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NCT ID: NCT01430611 Completed - Meningitis Clinical Trials

Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine in Children

Start date: August 2011
Phase: Phase 4
Study type: Interventional

This study is part of the post-licensure commitment to evaluate the safety and immunogenicity of Meningo A+C vaccine in healthy Chinese children 2 to 6 years of age. Primary Objective: To demonstrate the non-inferiority in terms of seroconversion rate for serogroups A and C, 30 days after a single dose of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine. Secondary Objective: - To describe the immunogenicity for serogroups A and C, 30 days after administration of the study vaccines given as a single dose. - To describe the full reactogenicity profile after administration of the study vaccines given as a single dose.

NCT ID: NCT01423084 Completed - Clinical trials for Meningococcal Disease

Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years

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

The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1 to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and as measured by ELISA geometric mean concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days after a primary vaccination course of two doses administered one month apart.

NCT ID: NCT01367158 Completed - Clinical trials for Meningococcal Disease

Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY Combination Vaccine in Adolescents Who Previously Received the Same Study Vaccines

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

This study will evaluate safety, tolerability, and immunogenicity of a booster dose of a meningococcal vaccine formulation in adolescents.

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: 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: 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: NCT01214837 Completed - Clinical trials for Meningococcal Disease

Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life

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

The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule including kinetics of immune response in the early phases of the series.

NCT ID: NCT01210885 Completed - Clinical trials for Meningococcal Disease

Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents

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

The purpose of this phase 2 study is to evaluate the safety, tolerability and immunogenicity of two doses of 4 different investigational MenABCWY combination vaccine when administered to healthy adolescents aged 11-18 years.

NCT ID: NCT01148524 Completed - Clinical trials for Meningococcal Disease

Assessment of Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10

Start date: August 2010
Phase: Phase 2/Phase 3
Study type: Interventional

This was a Phase 2b/3, multi-center, extension study of V72P10 to assess antibody persistence at 18 months after the vaccination course in study V72P10 (NCT00661713). Subjects who participated in study V72P10, and who meet all other enrollment criteria for this extension study, and a group of naïve subjects (defined as subjects who had never received rMenB+OMV NZ or other experimental MenB vaccines) of similar age to the subjects who were eligible to participate in this extension study, performed one study visit in which a single blood sample was drawn for MenB serological analyses.