A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults

Inclusion Criteria:

Female and male subjects who must be healthy and must be:

1. Between 18 and 60 years of age inclusive and who have given their written informed consent;
2. Available for all visits and telephone calls scheduled for the study;
3. In good health as determined by medical history, physical examination and clinical judgment of the investigator;
4. For female subjects, having a negative urine pregnancy test.

Exclusion Criteria:

Individuals not eligible to be enrolled in the study are those:

1. who are breastfeeding;
2. who have a personal history of Neisseria meningitidis infection, typhoid fever, rabies, or any flavivirus infection (e.g., Japanese encephalitis, tick-borne encephalitis, yellow fever, dengue fever, West Nile virus infection);
3. who have been immunized with any of the study vaccines within the last five years as determined by medical history and/or vaccination card;
4. who have received investigational agents or vaccines within 30 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to completion of the study;

5. who have received live licensed vaccines within 30 days and inactive vaccine within 15 days prior to enrollment or for whom receipt of a licensed vaccine is anticipated during the study period.

   (Exception: Influenza vaccine may be administered up to 15 days prior to each study immunization and no less than 15 days after each study immunization);

6. who have received an anti-malaria drug, up to 2 months prior to the study;
7. who have experienced, within the 7 days prior to enrollment, significant acute infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as body temperature ≥ 38°C) within 3 days prior to enrollment;

8. who have any serious acute, chronic or progressive disease such as:

   • history of cancer
   • complicated diabetes mellitus
   • advanced arteriosclerotic disease
   • autoimmune disease
   • HIV infection or AIDS
   • blood dyscrasias
   • congestive heart failure
   • renal failure
   • severe malnutrition (Note: Subjects with mild asthma are eligible for enrollment. Subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids are not eligible for enrollment);
9. who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
10. who have a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component, including but not limited to latex allergy, egg allergy, antibiotic allergy, chicken proteins or gelatin allergy;

11. who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):

    • receipt of immunosuppressive therapy within 30 days prior to enrollment (systemic corticosteroids administered for more than 5 days, or in a daily dose > 1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy);
    • receipt of immunostimulants;
    • receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study;
12. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
13. who have myastenia gravis; thyroid or thymic disorders,
14. who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
15. who are part of the study personnel or close family members of those conducting this study.