Estudio de extensión, fase 2b, abierto, multicéntrico, para evaluar la seguridad, tolerabilidad e inmunogenicidad de una dosis de refuerzo de la vacuna recombinante de Novartis contra el meningococo del grupo B administrada a los 12,18 ó 24 meses de edad a niños que con anterioridad hayan recibido una primera serie de tres dosis de la vacuna recombinante de Novartis contra el meningococo del grupo B en el estudio V72P12

Conditions: so de una cuarta dosis (dosis de refuerzo) de rMenB+OMV NZ para evaluar la seguridad, tolerabilidad e inmunogenicidad y explorar la persistencia de anticuerpos bactericidas a los 12, 18 y 24 meses de edad en la prevención de la meningitis y/o septicemia causada por N. meningitidis de tipo B. Se administrarán dos dosis de puesta al día de rMenB+OMV NZ a niños aún no inmunizados para generar datos para evaluar la seguridad e inmunogenicidad de un régimen de puesta al día de dos dosis.

Registration Number: EUCTR2009-011676-30-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: 1900

Inclusion Criteria

1. Group 5: healthy 18-month-old toddlers (0/ +29 days window); Group 6: healthy 24-month-old toddlers (0/ +29 days window); 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, clinical judgment of the investigator Inclusion Criteria for follow-on participants (Groups 1, 2, 3 and 4): Inclusion criteria are the same as for Groups 5 and 6, with the addition that are subjects: 1. who participated and completed V72P12 study 2. who are aged: o 12 months or older - Groups 1a, 2a, 3a, 4 o 18 months (0/ +29 days window) - Groups 1b, 2b, 3b) o 24 months (0/ +29 days window) - Groups 1c, 2c, 3c)
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

Exclusion Criteria

1.subjects whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study; 2.history of any meningococcal B vaccine administration (only groups 5 and 6); 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 ³ 38°C within the day before Visit 1; 7.antibiotics within 7 days prior to Visit 1; 8.any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, 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, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 30 days prior to Visit 1; 10.receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to Visit 1; 11.receipt of, or intent to immunize with any other vaccine(s), within 30 days prior to Visit 1; 12.participation in another clinical trial within 90 days prior to enrolment or planned for during study; 13.family members and household members of research staff; 14.any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.