Healthy volunteers (Meningitis B) MedDRA version: 14.1 Level: PT Classification code 10027249 Term: Meningitis meningococcal System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Novartis Vaccines and Diagnostics Meningococcal B Recombinant Vaccine
Product Code: 4CMenB
Pharmaceutical Form: Solution for injection
INN or Proposed INN: MENINGOCOCCAL VACCINE
Current
Sponsors
NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 – 60 years of age inclusive who have given written informed consent at the time of enrollment; 2. Able to comprehend and follow all required study procedures; 3. Who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period); 4. In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator; 5. Who were or might be routinely exposed to N. meningitidis cultures and/or are travelling to geographical areas considered at high risk for epidemic Meningococcal B infection disease. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature = 38°C|100.4ºF) within the previous day; 2.Antibiotics within 3 days (72 hours) prior to enrollment; 3. Pregnancy or nursing (breastfeeding) mothers; 4. Females 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 30 days prior to study entry; 5.Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); 6.Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body is allowed]; immunostimulants; 7.History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component; 8.Any condition which in the opinion of the investigator may interfere with evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To descriptively assess the safety of Novartis rMenB+OMV NZ in healthy at-risk adults when administered at a 0, 2- month schedule, throughout the clinical study.;Secondary Objective: NA;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Italy
Contacts
Public ContactRicerca Clinica
Novartis Vaccines and Diagnostics
Outcome results
None listed