Infections, Meningococcal Clinical Trial
Official title:
Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 Administered in Healthy Subjects Either Previously Primed With Mencevax™ ACWY or naïve to Meningococcal Vaccination.
In this study, subjects who were vaccinated with a meningococcal polysaccharide vaccine in a
previous study (whose objectives & outcome measures are presented in a separate protocol
posting with NCT number = 00227422) will be vaccinated with a new vaccine using conjugation
technology.
These subjects will be compared to subjects vaccinated with the new vaccine, but who were not
previously vaccinated with a meningococcal polysaccharide vaccine.
GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate
vaccine has been shown to be well tolerated and immunogenic in toddlers, children aged 3-5
years, and adolescents/young adults. Repeated vaccinations with unconjugated meningococcal
polysaccharide vaccine has shown to induce hyporesponsiveness to re-vaccination, this for
serogroup C, and a recent publication suggest the same may be true for other serogroups.
This study will evaluate GSK Biologicals' candidate vaccine's ability to induce satisfactory
immune response for the serogroups it contains across subjects 4.5 through 34 years of age
who previously received a tetravalent meningococcal polysaccharide vaccine when aged 2-30
years. A non-randomised age-strata matched group of subjects, who have not previously
received (or not received within the preceding 10 years) any meningococcal vaccine, will also
be administered the GSK134612 vaccine for comparison.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) Administered to Healthy Adults 18 to 40 Years of Age
|
Phase 2 | |
| Completed |
NCT02223637 -
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
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||
| Completed |
NCT00974363 -
Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612
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Phase 3 | |
| Completed |
NCT00196950 -
Study to Evaluate Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 18-25 Years
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Phase 2 | |
| Completed |
NCT00514904 -
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
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Phase 3 | |
| Completed |
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Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan.
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Phase 3 | |
| Completed |
NCT01641042 -
Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects
|
Phase 3 | |
| Completed |
NCT01682876 -
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 |
NCT00758264 -
Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration
|
Phase 3 | |
| Completed |
NCT01962207 -
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 |
NCT00718666 -
The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Toddlers
|
Phase 2 | |
| Completed |
NCT01939158 -
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
|
Phase 3 | |
| Completed |
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|
Phase 3 | |
| Active, not recruiting |
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A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants
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Phase 2 | |
| Completed |
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Combined Study - Phase 3b MenB Long Term Persistence in Adolescents
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Phase 3 | |
| Completed |
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|
Phase 2 | |
| Completed |
NCT00674583 -
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
|
Phase 3 | |
| Completed |
NCT00464815 -
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects
|
Phase 3 | |
| Completed |
NCT00196976 -
Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old
|
Phase 2 |