Status and phase
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Study type
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About
The study will evaluate the immunogenicity and safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Sponsor's employees are considered eligible to participate in the trial as per inclusion criteria.
Exclusion criteria
Pregnancy or nursing (breastfeeding) mothers;
Females of reproductive age who have not used or do not plan to use acceptable birth control measures, for the 3 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods for at least 60 days prior to study entry;
Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease);
Individuals with history of any progressive or severe neurologic disorder, or seizure disorder. A single episode of febrile convulsion is not an exclusion criteria;
History of any serogroup B meningococcal vaccine administration;
Previous known or suspected disease caused by N. meningitidis;
History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine;
Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):
Subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study;
History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
Any significant chronic infection;
Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time;
Family members and household members of research staff;
Participation in another clinical trial within the last 30 days or planned for during study.
Primary purpose
Allocation
Interventional model
Masking
13 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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