Infections, Meningococcal Clinical Trial
Official title:
Long Term Antibody Persistence Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Administered as 1 or 2 Doses to Healthy Toddlers at 9-12 Months of Age and as a Booster Dose 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 in a previous study (whose objectives & outcome measures are presented in a
separate protocol posting with NCT number =00471081) will be evaluated. The safety and immune
response of a booster dose of vaccine GSK134612 administered at 5 years post-primary
vaccination will also be evaluated. In addition, the immune response to a dose of vaccine
GSK134612 administered to age-matched controls not previously given a meningococcal vaccine
will be evaluated.
This protocol posting has been updated further to protocol amendment 2, dated 28 october
2010. The sections impacted are summary, study design, outcome measures, intervention, and
eligibility criteria.
GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate
vaccine has been shown to be well tolerated and immunogenic in toddlers.
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 or two doses of GlaxoSmithKline (GSK)
Biologicals' meningococcal vaccine GSK134612 when given to healthy toddlers 9-12 months of
age. To evaluate, the safety and immunogenicity of a booster dose of GSK134612 administered
to all eligible subjects at 5 years after the primary vaccination. To evaluate the safety and
immunogenicity in a new group of subjects aged 5-6 years (naive control group) who will
receive a single dose of vaccine GSK134612.
;
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Phase 3 | |
| Completed |
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Phase 2 | |
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Phase 3 | |
| Completed |
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Phase 3 | |
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|
Phase 3 | |
| Completed |
NCT00758264 -
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
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Phase 3 | |
| 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 | |
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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
|
Phase 3 | |
| Completed |
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Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine Administered 6 Years Post-MenC Primary Vaccination in Healthy Subjects Who Were 12-18 Months at Primary Vaccination
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Phase 3 | |
| Completed |
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Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects
|
Phase 3 | |
| Completed |
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|
Phase 2 | |
| Completed |
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Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old
|
Phase 2 |