Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:August 2011
End Date:September 2012
Contact:Novartis Drug Information Services
Phone:+1-800-244-7668

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Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents and Young Adults to Evaluate Safety and Immunogenicity of Two Different rMenB With OMV + MenACWY Combination Vaccination Formulations


This study will evaluate the safety and immunogenicity of combination vaccines as compared
to the reference vaccines


Inclusion Criteria:

- Healthy adolescents aged 10 to 25 years of age inclusive at the time of enrollment.

Exclusion Criteria:

- History of any meningococcal vaccine administration;

- Current or previous, confirmed or suspected disease caused by N. meningitidis;

- Pregnant or nursing (breastfeeding) mothers;

- Females of childbearing age who have not used or do not plan to use acceptable birth
control measures, for the duration of the study;

- Any serious, chronic, or progressive disease;

- Known or suspected impairment/alteration of the immune system;

- Receipt of blood, blood products and/or plasma derivatives, or a parenteral
immunoglobulin preparation within the previous 90 days;

- History of severe allergic reactions after previous vaccinations or hypersensitivity
to any vaccine component.
We found this trial at
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Lebanon, Tennessee 37087
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