Infections, Meningococcal Clinical Trial
Official title:
Phase IIb Primary Vaccination Study to Evaluate Non-Inferiority & Persistence of the Immune Response of GSK Biologicals' MenACWY Conjugate Vaccine (Intramuscularly) vs Mencevax ACWY (Subcutaneously) to Healthy Subjects (11-55 Years of Age)
Meningococcal disease is mostly caused by N. meningitidis of serogroups A, B, C, W-135, Y. Meningococcal polysaccharide-conjugate vaccines have the advantage to induce a T-cell dependant immune response while the existing polysaccharide vaccines induce a T-cell independent response, i.e. with no immune memory response. GSK Biologicals has developed a combined Men ACWY conjugate vaccine intended to protect against meningococcal disease due to serogroups A, C, W-135 and Y. In the vaccination phase of this study, the new MenACWY-TT conjugate vaccine will be evaluated in adolescents and adults using Mencevax™ ACWY as control. In the long-term follow-up phase (extension phase) of the study, the long-term protection offered by the new MenACWY-TT conjugate vaccine will be assessed up to five years after the vaccination in adolescents and adults using Mencevax™ ACWY as control. This protocol posting deals with objectives & outcome measures of both the primary & extension phases.
All subjects will have 7 blood samples taken: prior to and one month after vaccination and
one, two, three, four and five years after vaccination. No new subjects will be enrolled in
the extension phases of this Phase IIb study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act,
September 2007.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03652610 -
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
|
||
| Completed |
NCT00974363 -
Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612
|
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
|
Phase 2 | |
| Completed |
NCT00514904 -
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
|
Phase 3 | |
| Completed |
NCT02173704 -
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.
|
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 |
NCT01235975 -
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years
|
Phase 3 | |
| Active, not recruiting |
NCT05082285 -
A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants
|
Phase 2 | |
| Completed |
NCT02446743 -
Combined Study - Phase 3b MenB Long Term Persistence in Adolescents
|
Phase 3 | |
| Completed |
NCT02946385 -
Study to Assess the Immunological Long-term Persistence of Antibodies (Abs) 2 Years After GlaxoSmithKline (GSK) Meningococcal ABCWY Vaccination in the V102_15 (NCT02212457) and Response to a Booster in Adolescents
|
Phase 2 | |
| Completed |
NCT00674583 -
Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children
|
Phase 3 | |
| Completed |
NCT01777308 -
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 |
NCT00661557 -
Comparison of GSK134612 in Subjects Previously Vaccinated Against Meningococcal Disease Versus Non-vaccinated Subjects
|
Phase 2 |