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:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00661713
First received: April 16, 2008
Last updated: October 24, 2011
Last verified: October 2011

April 16, 2008
October 24, 2011
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: Serogroup B meningococcal Vaccine
    One dose of rMenB at study months 0 and 6 and placebo at study months 1 and 2.
  • Biological: Serogroup B meningococcal Vaccine

    One dose of rMenB at study month 0 and placebo at study months

    1, 2 and 6.

  • Biological: Serogroup B meningococcal Vaccine
    One dose of rMenB at study months 0, 1 and 6 and placebo at study month 2.
  • Biological: Serogroup B meningococcal Vaccine
    One dose of rMenB at study months 0 and 1 and placebo at study months 2 and 6.
  • Biological: Serogroup B meningococcal Vaccine
    One dose of rMenB at study months 0, 2 and 6 and placebo at study month 1.
  • Biological: Serogroup B meningococcal Vaccine
    One dose of rMenB at study months 0 and 2 and placebo at study months 1 and 6.
  • Biological: Serogroup B meningococcal Vaccine
    One dose of rMenB at study months 0, 1 and 2 and placebo at study month 6.
  • Biological: Serogroup B meningococcal Vaccine
    One dose of placebo at study months 0, 1, 2 and one dose of rMenB at study month 6.
  • Experimental: 1
    Intervention: Biological: Serogroup B meningococcal Vaccine
  • Experimental: 2
    Intervention: Biological: Serogroup B meningococcal Vaccine
  • Experimental: 3
    Intervention: Biological: Serogroup B meningococcal Vaccine
  • Experimental: 4
    Intervention: Biological: Serogroup B meningococcal Vaccine
  • Experimental: 5
    Intervention: Biological: Serogroup B meningococcal Vaccine
  • Experimental: 6
    Intervention: Biological: Serogroup B meningococcal Vaccine
  • Experimental: 7
    Intervention: Biological: Serogroup B meningococcal Vaccine
  • Experimental: 8
    Intervention: Biological: Serogroup B meningococcal Vaccine
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
1627
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
Novartis Vaccines
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
October 2011

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