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

ovartis Vaccines and Diagnostics S.r.l.0 个研究点目标入组 1,900 人开始时间: 2009年10月9日最近更新: 2012年12月17日

适应症

试验速览

暂无简介。

•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.

发起方

ovartis Vaccines and Diagnostics S.r.l.