A Phase 2b, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis Meningococcal B Recombinant Vaccine Administered at 12, 18 or 24 Months of Age in Subjects Who Previously Received a Three-Dose Primary Series of the Novartis Meningococcal B Recombinant Vaccine as Infants in Study V72P12
- Conditions
- Prevention of meningitidis and/or septicemia caused by N.meningitidis serogroup B, A fourth (booster) dose of rMenB+OMV NZ is used to evaluate safety tolerability and immunogenicity and exploring the bactericidal antibody persistence at 12, 18 and 24 months of age. Two catch-up rMenB+OMV NZ doses will be given to unprimed, naïve toddlers to generate data for assessing the safety and immunogenicity of a two-dose catch-up regimen
- Registration Number
- EUCTR2009-011676-30-DE
- 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
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
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.
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