Infections, Meningococcal Clinical Trial
Official title:
Study to Assess Immunogenicity, Reactogenicity and Safety of 1 Dose of GSK Biologicals' Meningococcal Vaccine GSK134612 vs. 1 Dose of Sanofi-Pasteur's Menactra® in Healthy Subjects 10-25 Years.
The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK
Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults
11-25 years of age.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
The protocol posting has been updated following a protocol amendment.
Subjects 11-25 years of age will be randomized to receive either the meningococcal vaccine
GSK134612 or Menactra®. An additional non-randomized group of subjects aged 10 years (< 11
years of age) will be enrolled to receive meningococcal vaccine GSK134612 only (At the time
the study begun, Menactra® was only licensed in the United States for individuals above 11
years of age and therefore could not be used as a control vaccine in subjects less than 11
years old).
This study will be single-blind for the subjects 11 to 25 years of age and open for the
subjects 10 to < 11 years of age.
;
| 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 |