Clinical Trial: Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Immunocompr
Brief Summary: 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.
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome:
- Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain. [ Time Frame: Day 1 and Day 91 (one month after the second dose of the study vaccine) ]Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 5 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+Outer Membrane Vesicle (OMV) NZ, administered on Day 1 and Day 61.
- Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain. [ Time Frame: Day 1 and Day 91 (one month after the second dose of the study vaccine). ]Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 8 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
- Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule. [ Time Frame: Day 1 and Day 91 (one month after the second dose of the study vaccine). ]Immunogenicity was assessed in terms of GMRs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
- Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule. [ Time Frame: Day 1 and Day 91 (one month
Original Primary Outcome:
- 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 [ Time Frame: 30 days after 2nd vaccination ]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.
- percentage of subject with four-fold increase in hSBA titers against serogroups B indicator strains and in ELISA concentration for vaccine antigen 287-953 [ Time Frame: 30 days after 2nd vaccination ]
- Frequencies and percentage of subjects with solicited AE unsolicited AE, medically attended AEs, AEs leading to withdrawn and SAEs [ Time Frame: participants will be followed for the duration of study, within an expected average of 3 months ]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
Current Secondary Outcome: Number of Subjects Reporting Solicited Local and Systemic AEs. [ Time Frame: From Day 1 until Day 7 after any vaccination. ]
Reactogenicity was presented in terms of percentages of subjects reporting solicited local and systemic AEs and other indicators.
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: May 15, 2014
Date Started: May 2014
Date Completion:
Last Updated: December 22, 2016
Last Verified: July 2016
- 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 [ Time Frame: 30 days after 2nd vaccination ]