Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents

Completed · Phase 2 · Has a placebo group

Conditions studied: Infections, Meningococcal

In brief

The main purposes for conducting the study are firstly to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine (Bexsero™) in terms of hSBA GMTs at one month after the second vaccination, secondly to give the flexibility for the national vaccination program by showing the safety and immunogenicity of MenABCWY administrated according to four different vaccination schedules and additionally to evaluate a potential benefit of the 3-dose vaccination series.

Key facts

Study ID

NCT02212457

Run by

GlaxoSmithKline

People needed

1063

Starts

2014-08-21

Expected to finish

2016-03-03

Last updated by the study team

2019-06-27

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adolecents from 10-18 yearsof age, generally in good health, and available for all study visits, and who/whose legally acceptable representative has given written informed consent at the time of enrollment.
• Individuals of who the investigator believes can and will comply with the requirements of the protocol (e.g. use of an eDiary, return for follow-up visits, available for phone contacts).
• Female subjects of childbearing potential must have a negative urine preganancy test.

You may not qualify if…

• Serious, acute, or chronic illness. Previous or suspected disease caused by N. meningitidis. Previous immunization with any menincococcal or Hepatitis A vaccines.
• Exposure to individuals with clicically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characteriszation.

Where it is running

• GSK Investigational Site — Jonesboro, Arkansas, United States
• GSK Investigational Site — Hialeah, Florida, United States
• GSK Investigational Site — Melbourne, Florida, United States
• GSK Investigational Site — Augusta, Kansas, United States
• GSK Investigational Site — Niles, Michigan, United States
• GSK Investigational Site — Saint Paul, Minnesota, United States
• GSK Investigational Site — Bellevue, Nebraska, United States
• GSK Investigational Site — Omaha, Nebraska, United States
• GSK Investigational Site — Binghamton, New York, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Dayton, Ohio, United States
• GSK Investigational Site — Charleston, South Carolina, United States
• GSK Investigational Site — Mt. Pleasant, South Carolina, United States
• GSK Investigational Site — Espoo, Finland
• GSK Investigational Site — Helsinki, Finland
• GSK Investigational Site — Helsinki, Finland
• GSK Investigational Site — Jarvenpaa, Finland
• GSK Investigational Site — Kokkola, Finland
• GSK Investigational Site — Oulu, Finland
• GSK Investigational Site — Pori, Finland
• GSK Investigational Site — Seinäjoki, Finland
• GSK Investigational Site — Tampere, Finland
• GSK Investigational Site — Turku, Finland
• GSK Investigational Site — Vantaa, Finland
• GSK Investigational Site — Dębica, Poland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.