Status:
COMPLETED
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Meningococcal Disease
Meningococcal Meningitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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
- Female and male subjects who must be healthy and must be:
- Between 18 and 60 years of age inclusive and who have given their written informed consent;
- Available for all visits and telephone calls scheduled for the study;
- In good health as determined by medical history, physical examination and clinical judgment of the investigator;
- For female subjects, having a negative urine pregnancy test.
Exclusion
- Individuals not eligible to be enrolled in the study are those:
- who are breastfeeding;
- 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);
- who have been immunized with any of the study vaccines within the last five years as determined by medical history and/or vaccination card;
- 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;
- 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);
- who have received an anti-malaria drug, up to 2 months prior to the study;
- 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;
- 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);
- who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
- 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;
- 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;
- who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
- who have myasthenia gravis; thyroid or thymic disorders,
- who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
- who are part of the study personnel or close family members of those conducting this study.
- for whom a long-term stay (≥ 1 month) was planned in Africa, Latin America, or Asia.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
552 Patients enrolled
Trial Details
Trial ID
NCT01466387
Start Date
November 1 2011
End Date
April 1 2012
Last Update
March 11 2014
Active Locations (5)
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1
Centrum ockovani a cestovni mediciny (Vaccination and Travel Medicine Centre) Poliklinika II
Bratri Stefanu 895, Hradec Kralove, Czechia, 500 03
2
Bernhard Nocht Strasse 74, Hamburg, Germany, 20359
3
Berliner Centrum Fur Reise und Tropenmedizin
Jaegerstrasse 67-69, State of Berlin, Germany, 10117
4
University of Munich Georgenstr.5
München, Germany, 80799