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

This is an interventional prevention trial for Meningococcal Disease focused on measuring Adults, international travel vaccination, Meningococcal disease, meningococcal meningitis, typhoid, yellow fever, rabies, Japanese encephalitis Read More

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 myasthenia 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.
16. for whom a long-term stay (≥ 1 month) was planned in Africa, Latin America, or Asia.