A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults
Condition: Meningococcal Disease; Meningococcal Meningitis; Typhoid; Yellow Fever; Rabies; Japanese Encephalitis
MeSH terms: Rabies; Encephalitis, Japanese; Typhoid Fever; Yellow Fever; Meningococcal Infections; Meningitis, Meningococcal; Meningitis; Encephalitis
Intervention: Typhoid Vi Polysaccharide Vaccine; Yellow Fever Vaccine; Japanese Encephalitis Vaccine; Rabies Vaccine; MenACWY-CRM Vaccine
Intervention description: One dose of typhoid Vi polysaccharide vaccine.; One dose of yellow fever vaccine.; Two doses of Japanese Encephalitis Vaccine.; Three doses of Rabies vaccine.; One dose of MenACWY-CRM vaccine.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 552.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adults; international travel vaccination; Meningococcal disease; meningococcal meningitis; typhoid; yellow fever; rabies; Japanese encephalitis

Summary:

      This study compares the safety and immunogenicity profile of several travel vaccines given
      alone or concomitantly with MenACWY-CRM to healthy adults.
    

Eligibility criteria:

        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.