Infections, Meningococcal Clinical Trial
Official title:
Long-term Antibody Persistence of GSK Biologicals' MenACWY-TT Vaccine Versus Menactra® in Healthy Adolescents/Adults Aged 10-25 Years and Booster Response to MenACWY-TT Vaccine Administered at 5 Years Post-primary Vaccination
In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 and Menactra® in a previous study (whose objectives & outcome measures are presented in a separate protocol posting with NCT number =00454909) will be evaluated. The safety and immune response to a booster dose of vaccine GSK134612 administered at 5 years post-primary vaccination and a primary vaccination of a newly enrolled group with GSK 134612 vaccine will also be evaluated.
GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate
vaccine has been shown to be well tolerated and immunogenic in subjects as of 12 months of
age.
The purpose of this study is to evaluate the antibody persistence at approximately 1 year, 3
years and 5 years post-administration of one dose of GlaxoSmithKline (GSK) Biologicals'
meningococcal vaccine GSK134612 as compared to Menactra® (meningococcal serogroups A, C,
W-135 and Y-diphtheria toxoid conjugate vaccine, sanofi pasteur) when given to healthy
adolescents/ adults 11 to 25 years of age In addition, the safety and immunogenicity of a
booster dose of GSK134612 administered to all eligible subjects at 5 years after the primary
vaccination will be evaluated.
Another cohort of subjects (naïve control group) 15 to <31 years of age will be offered a
dose of MenACWY-TT vaccine at the same time to allow for evaluation of a primary (naïve
control group) and booster dose within the same study.
This Protocol Posting has been updated following Protocol Amendment 1, May 2010 and Protocol
Amendment 2, May 2011.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 2 | |
| Completed |
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||
| Completed |
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|
Phase 3 | |
| Completed |
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Phase 2 | |
| Completed |
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Phase 3 | |
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Phase 3 | |
| Completed |
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Phase 3 | |
| Completed |
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Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.
|
Phase 3 | |
| Completed |
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Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration
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Phase 3 | |
| Completed |
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The Long-term Antibody Persistence of MenACWY-TT Vaccine (PF-06866681) Versus Meningitec(Registered) or Mencevax(Registered) ACWY in Healthy Adolescents and Adults and a Booster Dose of MenACWY-TT Administered 10 Years Post Primary Vaccination
|
Phase 3 | |
| Completed |
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|
Phase 2 | |
| Completed |
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Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine
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Phase 3 | |
| Completed |
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Phase 3 | |
| Active, not recruiting |
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Phase 2 | |
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Phase 3 | |
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|
Phase 2 | |
| Completed |
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Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children
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Phase 3 | |
| Completed |
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|
Phase 3 | |
| Completed |
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|
Phase 3 | |
| Completed |
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Phase 2 |