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 |
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.
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