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 tollerbility 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-CZ
- 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; 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 7 days prior to enrollment; 8. any serious chronic or progressive disease 9. known or suspected impairment/alteration of the immune system10. receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation receipt of, or intent to immunize with any other vaccine(s), within 30 days prior to enrollment; 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