Trial to Assess Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 10 - 18 |
| Updated: | 4/21/2016 |
| Start Date: | August 2014 |
| End Date: | March 2016 |
A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered at Different Schedules Compared to Novartis Meningococcal Group B Vaccine, in Healthy Adolescents
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.
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.
Inclusion Criteria:
1. 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.
2. 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).
3. Female subjects of childbearing potential must have a negative urine preganancy test.
Exclusion Criteria:
1. Serious, acute, or chronic illness. Previous or suspected disease caused by N.
meningitidis. Previous immunization with any menincococcal or Hepatitis A vaccines.
2. Exposure to individuals with clicically proven meningococcal disease or clinical
bacterial meningitis without further microbiologic characteriszation.
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