A Phase 1, Observer Blinded, Single-center, Randomized Study of the Safety, Tolerability and Immunogenicity of three different formulations of a Meningococcal ABCWY Combination Vaccine When Administered at a 0, 2-Month Schedule in Healthy Adults 18-45 Years of Age

Individuals not enrolled into this study were those with: 1. A history of any meningococcal vaccine administration; 2. A current or previous, confirmed or suspected disease caused by Neisseria meningitidis; 3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment; 4. Experienced fever (defined as body temperature ≥38.0 °C) within the previous 3 days or are suffering from a current acute infection; 5. Taken antibiotics within 7 days prior to enrollment; 6. Pregnant or nursing (breastfeeding) mothers or females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry and must be willing to use it until the end of the study 7. Any serious chronic or progressive disease (e.g., any history of neoplasm, diabetes, cardiac disease, hepatic disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, signs of cardiac or renal failure or severe malnutrition). (Exception: subjects with mild asthma are eligible for enrollment. Subjects with moderate or severe asthma requiring chronic use of inhaled or systemic corticosteroids are not eligible for enrollment); 8. Any progressive neurological disease, seizure disorder, or Guillain Barré Syndrome; 9. Known or suspected impairment/alteration of the immune system, resulting from:

• receipt of immunosuppressive therapy, including use of corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 60 days;
• receipt of immunostimulants 10. An inherited genetic anomaly (known cytogenic disorders, e.g., Down's Syndrome); 11. An AST or ALT > 1.25x laboratory upper limit; 12. A creatinine (Cr) > 1.5x laboratory upper limit; 13. Received blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days; 14. A history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component; 15. Received, or for whom there was intent to be immunized with any other vaccine(s) within 30 days prior and throughout the study period (exception: licensed flu-vaccine should not be administered within 14 days prior to enrollment); 16. Obese at screening (e.g., with a body mass index [BMI] ≥30 where BMI reflects obesity and not high muscle mass); 17. Received another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study; 18. A current problem or a history of substance abuse which, in the opinion of the investigator or medical monitor, might interfere with participation in the study; 19. Any condition which in the opinion of the investigator and/or the medical monitor that may have interfered with the evaluation of the study objectives.