Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00661713
First received: April 16, 2008
Last updated: June 26, 2014
Last verified: June 2014

April 16, 2008
June 26, 2014
June 2008
April 2010   (final data collection date for primary outcome measure)
  • Immunogenicity of one, two or three doses of Novartis Meningococcal B vaccine as measured by percentage of subjects with serum bactericidal activity (SBA) titer ≥ 1:4 at baseline, Month 1, Month 2, Month 3. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Safety of 1, 2 or 3 doses of Novartis MenB Vaccine assessed by frequency of solicited local and systemic reactions collected for 7 days after each study vaccine injection and evaluation of occurrence of AE and SAE during the duration of all the study [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Immunogenicity of one, two or three doses of Novartis Meningococcal B vaccine as measured by percentage of subjects with serum bactericidal activity (SBA) titer ≥ 1:4 at baseline, Month 1, Month 2, Month 3, Month 6 and Month 7 [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Safety of 1, 2 or 3 doses of Novartis MenB Vaccine assessed by frequency of solicited local and systemic reactions collected for 7 days after each study vaccine injection and evaluation of occurrence of AE and SAE during the duration of all the study [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00661713 on ClinicalTrials.gov Archive Site
  • Immunogenicity at month 6 and 7 as measured by geometric mean titers (GMTs), geometric mean ratios (GMRs) computed for each visit and meningococcal B strain. For Group 5 unadjusted geometric mean titers (GMTs) will be computed up to Month 6. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Immunogenicity of 1, 2 or 3 doses of Novartis MenB Vaccine as measured by: % of subjects with a SBA titer ≥ 1:8 measured at baseline, 1, 2, 3, 6 and Month 7; % of subjects with at least a fourfold rise in SBA titer over the pre-vaccination titer. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Safety of an additional dose of Novartis MenB vaccine, given at month 6 assessed by frequency of solicited local and systemic reactions collected for 7 days after vaccine injection and evaluation of occurrence of AE and SAE.
  • Immunogenicity of 1, 2 or 3 doses of Novartis MenB Vaccine as measured by geometric mean titers (GMTs), geometric mean ratios (GMRs) computed for each visit and meningococcal B strain. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Immunogenicity of 1, 2 or 3 doses of Novartis MenB Vaccine as measured by: % of subjects with a SBA titer ≥ 1:8 measured at baseline, 1, 2, 3, 6 and Month 7; % of subjects with at least a fourfold rise in SBA titer over the pre-vaccination titer [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules
A Phase 2b/3, Multi-Center, Observer-Blind, Controlled Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents Aged 11-17 Years According to Different Vaccination Schedules

The proposed study is aimed to assess the antibody response and short-term persistence of Novartis Meningococcal B Vaccine after one, two or three doses and to evaluate the optimal vaccination schedule in an adolescent population.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Meningococcal Disease
  • Biological: rMenB+OMV NZ
    Other Name: Serogroup B Meningococcal Vaccine
  • Biological: Placebo
  • Experimental: rMenB06
    Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and two injections of placebo (at month 1, month 2). A second injection of rMenB+OMV NZ vaccine was given later (month 6).
    Interventions:
    • Biological: rMenB+OMV NZ
    • Biological: Placebo
  • Experimental: rMenB0
    Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and three injections of placebo (month 1, month 2 and month 6).
    Interventions:
    • Biological: rMenB+OMV NZ
    • Biological: Placebo
  • Experimental: rMenB016
    Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6).
    Interventions:
    • Biological: rMenB+OMV NZ
    • Biological: Placebo
  • Experimental: rMenB01
    Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and two injection of placebo (at month 2 and month 6).
    Interventions:
    • Biological: rMenB+OMV NZ
    • Biological: Placebo
  • Experimental: rMenB026
    Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6).
    Interventions:
    • Biological: rMenB+OMV NZ
    • Biological: Placebo
  • Experimental: rMenB02
    Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and two injections of placebo (at month 1 and month 6).
    Interventions:
    • Biological: rMenB+OMV NZ
    • Biological: Placebo
  • Experimental: rMenB012
    Subjects received three injections of rMenB+OMV NZ vaccine (at month 0, month 1 and month 2) and one injection of placebo later (at month 6).
    Interventions:
    • Biological: rMenB+OMV NZ
    • Biological: Placebo
  • Experimental: rMenB6
    Subjects received three injections of placebo(at month 0, month 1 and month 2) and one injection of rMenB+OMV NZ vaccine(at month 6).
    Interventions:
    • Biological: rMenB+OMV NZ
    • Biological: Placebo
Santolaya ME, O'Ryan ML, Valenzuela MT, Prado V, Vergara R, Muñoz A, Toneatto D, Graña G, Wang H, Clemens R, Dull PM; V72P10 Meningococcal B Adolescent Vaccine Study group. Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study. Lancet. 2012 Feb 18;379(9816):617-24. doi: 10.1016/S0140-6736(11)61713-3. Epub 2012 Jan 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1631
December 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 11-17 years of age inclusive who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment;

Exclusion Criteria:

  • History of any meningococcal B vaccine administration
  • Current or previous, confirmed or suspected disease caused by N. meningitidis
  • Pregnancy or nursing (breastfeeding) mothers
  • Females of childbearing age who have not used or do not plan to use acceptable birth control measures,
  • History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
  • Any serious chronic or progressive disease
  • Known or suspected impairment or alteration of the immune system
Both
11 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Chile
 
NCT00661713
V72P10
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP