Estudio de fase 2b, abierto, aleatorizado, de grupos paralelos y multicéntrico para evaluar la seguridad, tolerabilidad e inmunogenicidad de la vacuna recombinante contra el meningococo del grupo B de Novartis, administrada con o sin vacunaciones infantiles sistemáticas a niños sanos de acuerdo con diferentes esquemas de inmunización.A Phase 2b, Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered with or without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules
- Conditions
- a vacuna recombinante de Novartis, Meningococo B+OMV NZ está indicada para la prevención de la meningitis y/o septicemia provocada por N.meningitidis serogrupo B./The Novartis Meningococcal B Recombinant+OMV NZ Vaccine is intended for prevention of meningitidis and/or septicemia caused by N.meningitidis serogroup B.MedDRA version: 9.1Level: LLTClassification code 10027276Term: Meningococcal meningitis
- Registration Number
- EUCTR2008-001592-30-ES
- Lead Sponsor
- ovartis Vaccines and Diagnostics S.r.l.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1885
1. Healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age = 37 weeks and a birth weight = 2.5 kg.
2. For whom a parent/legal guardian has given written informed consent after the nature of the study has been explained.
3. Available for all the visits scheduled in the study.
4. In good health as determined by medical history, physical examination and clinical judgment of the investigator.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. History of any meningococcal B or C vaccine administration.
2. Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens.
3. Previous ascertained or suspected disease caused by N. meningitidis.
4. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis.
5. History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component.
6. Significant acute or chronic infection within the previous 7 days or axillary temperature = 38°C within the previous day.
7. Antibiotics within 6 days prior to enrollment.
8. Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, insulin dependent diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition).
9. Known or suspected impairment/alteration of the immune system, such as immunosuppressive therapy, including use of corticosteroids or chronic use of inhaled high-potency corticosteroids since birth.
10. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.
11. Receipt of, or intent to immunize with any other vaccine(s) (with the exception of rotavirus), within 30 days prior and throughout the study period.
12. Participation in another clinical trial since birth or planned for during study.
13. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method