Infections, Meningococcal Clinical Trial
Official title:
Booster Vaccination Study to Assess Safety & Reactogenicity of a Dose of DTPw-HBV/Hib Vaccine and to Assess the Immunogenicity, Safety & Reactogenicity of a Dose of Mencevax™ ACW in Subjects Primed in Study 759346/007
The purpose of this study is to assess the safety and reactogenicity of a booster dose of
diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b
vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and
reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal
vaccine (ACW) at 24 to 30 m in primed subjects.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
This open study will have two parallel groups based on the vaccination received in the
primary study: AC primed Group: primed with Tritanrix™-HepB/Hib-MenAC vaccine and AC unprimed
Group (control): primed with Tritanrix™-HepB/Hiberix™ vaccine. All subjects will receive a
booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age with GSK
Biological's OPV vaccine given concomitantly and a dose of Mencevax™ ACW vaccine at 24 to 30
months of age. Blood sampling will be done prior to (pre) and one month after (post) the
Mencevax™ ACW vaccine administration for immunogenicity analyses. The study will last minimum
7 to maximum 16 months per subject.
Mencevax™ ACWY was changed to Mencevax™ ACW throughout the posting to correct an
inconsistency in the earlier version of the protocol posting and to reflect the actual
situation.
;
| 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 |