Meningococcal Disease Clinical Trial
Official title:
A Phase IIIb, Open Label, Controlled, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Immunocompromised Patients From 2 to 17 Years of Age Who Are at Increased Risk of Meningococcal Disease Because of Complement Deficiency or Asplenia Compared to Matched Healthy Controls
The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered to subjects from 2 to 17 years of age with increased risk of meningococcal disease because either of primary or secondary complement deficiencies or of asplenia or splenic dysfunction. A group of healthy age-matched subjects will be enrolled to serve as a descriptive control for immunogenicity and safety.
Status | Completed |
Enrollment | 239 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 2 Years to 17 Years |
Eligibility |
Inclusion Criteria: Inclusion criterion applicable to ALL Groups - Subjects aged 2 to 17 years (inclusive) at enrollment - weighing at least 13 Kg at the time of enrollment Inclusion criterion applicable to Group A - Subjects at risk of meningococcal disease because of primary or secondary complement deficiencies Inclusion criterion applicable to Group B - Subjects at risk of meningococcal disease because of functional or anatomic asplenia Inclusion criterion applicable to Group C - healthy subjects Exclusion Criteria: Exclusion criteria applicable to All Groups (A, B and C) - History of any previous immunization with a meningococcal B vaccine - History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine - Known HIV infection - History of any progressive or severe neurologic disorder or seizure disorder - Contraindication to intramuscular injection or blood drawn - Females who are pregnant, planning a pregnancy or nursing (breastfeeding) - Females of childbearing potential who have not used or do not plan to use acceptable birth control measures - History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects Exclusion criterion applicable to Groups A and B - Previous known or suspected disease caused by N. meningitidis in the last year. Exclusion criteria applicable to Group C - Previous known or suspected disease caused by N. meningitidis - Known or suspected impairment/alteration of the immune system |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Italy | 12, Novartis Investigational Site | Firenze | |
Italy | 11, Novartis Investigational Site | Genova | |
Italy | 10, Novartis Investigational Site | Milano | |
Italy | 14, Novartis Investigational Site | Padova | |
Italy | 13, Novartis Investigational Site | Roma | |
Poland | 31, Novartis Investigational Site | Krakow | |
Poland | 33, Novartis Investigational Site | Warszawa | |
Poland | 30, Novartis Investigational Site | Wroclaw | |
Russian Federation | 41, Novartis Investigational Site | Moscow | |
Russian Federation | 42, Novartis Investigational Site | Moscow | |
Russian Federation | 43, Novartis Investigational Site | Yekaterinburg | |
Spain | 21, Novartis Investigational Site | Barcelona | |
Spain | 22, Novartis Investigational Site | Madrid | |
Spain | 23, Novartis Investigational Site | Madrid | |
Spain | 20, Novartis Investigational Site | Santiago De Compostela | |
Spain | 24, Novartis Investigational Site | Valencia | |
United Kingdom | 53, Novartis Investigational Site | London | |
United Kingdom | 52, Novartis Investigational Site | Manchester | |
United Kingdom | 50, Novartis Investigational Site | Oxford | |
United Kingdom | 51, Novartis Investigational Site | Southampton |
Lead Sponsor | Collaborator |
---|---|
Novartis | Novartis Vaccines |
Italy, Poland, Russian Federation, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | hSBA GMT, GMR, percentage of subjects with hSBA titers =5 and = 8 against serogroups B indicator strains and ELISA GMC, GMR for vaccine antigen 287-953 | To evaluate the immunogenicity of two doses of rMenB+OMV NZ in subjects with increased risk of meningococcal disease because of complement deficiency or asplenia and in healthy age-matched subjects, at 1 month after the second vaccination. | 30 days after 2nd vaccination | No |
Primary | percentage of subject with four-fold increase in hSBA titers against serogroups B indicator strains and in ELISA concentration for vaccine antigen 287-953 | 30 days after 2nd vaccination | No | |
Primary | Frequencies and percentage of subjects with solicited AE unsolicited AE, medically attended AEs, AEs leading to withdrawn and SAEs | To assess the safety and tolerability of two doses of rMenB+OMV NZ in subjects with increased risk of meningococcal disease because of complement deficiency or asplenia and in healthy age-matched subjects | participants will be followed for the duration of study, within an expected average of 3 months | Yes |
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