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Infections, Meningococcal clinical trials

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NCT ID: NCT00290329 Completed - Clinical trials for Infections, Meningococcal

Safety of Purified Meningococcal Vaccine With Serogroups ACWY, in 3,000 Filipino Subjects Aged > 2 Years

Start date: January 14, 2006
Phase: Phase 4
Study type: Interventional

GlaxoSmithKline Philippines has submitted a registration file for its Purified Meningococcal Polysaccharide of Serogroup ACWY Vaccine (Mencevax ACWY). This study is being conducted to collect clinical data in the local target population in order to assess the occurrence of rare adverse events after vaccination as per the requirement of Philippines Bureau of Food and Drugs Directive.

NCT ID: NCT00271479 Completed - Clinical trials for Infections, Meningococcal

Fractional Dose Tetravalent A, C, Y, W135 Meningococcal Polysaccharide Vaccine

Start date: June 2004
Phase: Phase 4
Study type: Interventional

Hypothesis: Lower doses of each A/C/Y/W135 component of the meningococcal polysaccharide vaccine could confer a similar functional immunogenic response as the dose of 50 μg currently being used, and subsequently be equally protective. The purpose of this study is to evaluate the use of fractional dose tetravalent meningococcal polysaccharide vaccine to control outbreak especially caused by N. meningitidis serogroup W135 Primary Objectives: - To measure the immunogenicity of a dose corresponding to one fifth of the amount of the licensed meningococcal A/C/Y/W135 polysaccharide vaccine, i.e. 10 μg for each component; and - To measure the immunogenicity of a dose corresponding to one tenth of the licensed meningococcal A/C/Y/W135 polysaccharide vaccine, i.e. 5 μg for each component.

NCT ID: NCT00227422 Completed - Clinical trials for Infections, Meningococcal

Assess the Non-inferiority of GSK Biologicals' Mencevax™ ACWY (Manufactured by a New Process) vs Mencevax™ ACWY (the Already Existing Vaccine in the Market) When Given as a Single Dose to Subjects Aged 2-30 Yrs

Start date: June 2005
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate that the vaccine produced with the new process and administered as a single dose is at least as good as the existing Mencevax™ ACWY vaccine in terms of immunogenicity, safety and reactogenicity, in healthy subjects aged 2-30 years.

NCT ID: NCT00196976 Completed - Clinical trials for Infections, Meningococcal

Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old

Start date: March 24, 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12-14 months and 3-5 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

NCT ID: NCT00196963 Completed - Clinical trials for Infections, Meningococcal

Evaluate 4 Different Formulations of Meningococcal Serogroups A, C, W-135, Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 Yrs

Start date: March 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy subjects aged 15-19 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose.

NCT ID: NCT00196950 Completed - Clinical trials for Infections, Meningococcal

Study to Evaluate Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 18-25 Years

Start date: September 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, reactogenicity, immunogenicity and persistence up to three years after administration of one dose of the MenACWY conjugate vaccine when given to young adults aged 18-25 years.

NCT ID: NCT00137917 Completed - Clinical trials for Infections, Meningococcal

Immunogenicity & Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 Yrs

Start date: July 2002
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of 3 doses of the meningococcal serogroup B vaccine when given, using either a 0-2-4 month or a 0-1-6 month schedule, to healthy adolescents aged 12-18 years; a control group will receive 2 doses of Havrix™ (0-6 months) and Meningitec™ (month 1).

NCT ID: NCT00135564 Completed - Clinical trials for Infections, Meningococcal

Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT and Hib-MenC-TT or Meningitec™ in Healthy Toddlers

Start date: January 2003
Phase: Phase 2
Study type: Interventional

The purpose of this booster vaccination study is to evaluate the persistence and immune memory induced by a three-dose primary vaccination course with GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) and GSK Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) or Meningitec™ vaccines in healthy toddlers aged 12-15 months by giving them a 1/5th dose of Mencevax™ ACWY.

NCT ID: NCT00135486 Completed - Clinical trials for Infections, Meningococcal

Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants

Start date: March 2002
Phase: Phase 2
Study type: Interventional

The purpose of this primary vaccination study is to evaluate the immunogenicity, safety and reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) vaccine (2 different formulations) and of three doses of GSK Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) vaccine (2 different formulations) when given to infants in their 3rd, 4th, and 5th months of life. Concomitant vaccines were given to all children to complete the vaccination agenda.

NCT ID: NCT00126984 Completed - Clinical trials for Infections, Meningococcal

Study in Children to Evaluate the Immunogenicity and Safety of 4 Formulations of GSK Bio MenACWY-TT Conjugate Vaccine

Start date: July 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12 14 months and 3 5 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.