a phase 3b, randomized, open-label study to evaluate the safety and immunogenicity of select travel vaccines when administered concomitantly with menacwy in adults

Conditions: 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.

Keywords: adults international travel vaccination meningococcal disease meningococcal meningitis typhoid yellow fever rabies japanese encephalitis