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Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00560313
First received: November 16, 2007
Last updated: December 8, 2011
Last verified: December 2011

November 16, 2007
December 8, 2011
July 2007
November 2009   (final data collection date for primary outcome measure)
  • Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination [ Time Frame: one month after vaccination ] [ Designated as safety issue: No ]
    Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains.
  • Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination [ Time Frame: one month after vaccination ] [ Designated as safety issue: No ]

    Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; %≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:

    • prior to the first vaccination
    • 30 days following the first, second, prior to the third and 30 days after the third vaccination
  • Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination [ Time Frame: one month after vaccination ] [ Designated as safety issue: No ]
    Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains.
  • Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination [ Time Frame: one month after vaccination ] [ Designated as safety issue: No ]

    Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; %≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:

    • prior to the first vaccination
    • 30 days following the first, second, prior to the third and 30 days after the third vaccination
  • Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination [ Time Frame: one month after vaccination ] [ Designated as safety issue: Yes ]
    the number of subjects who reported solicited reactions after the administration of the Meningococcal B vaccine at a 0, 2, 6-month schedule and the administration of the Meningococcal A, C, W, and Y vaccine at month 7.
  • Safety and tolerability of the two Meningococcal vaccines throughout the clinical study [ Time Frame: one month ]
  • Immunogenicity as measured by serum bactericidal activity of the Meningococcal B vaccine at one month after completion of immunization schedule [ Time Frame: one month ]
Complete list of historical versions of study NCT00560313 on ClinicalTrials.gov Archive Site
Not Provided
  • Immunogenicity as measured by serum bactericidal activity of the Meningococcal B vaccine at one month after the first and the second immunization [ Time Frame: one month ]
  • Immunogenicity as measured by serum bactericidal activity of the Meningococcal ACWY vaccine at one month after the immunization [ Time Frame: one month ]
Not Provided
Not Provided
 
Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults
A Phase 2, Multi-Center, Open-label Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2, 6-Month Schedule and of a Single Dose of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy At-risk Adults 18-50 Years of Age

This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to healthy at-risk adults.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Meningococcal Disease
  • Biological: Men ACWY CRM
    a single dose of a 0.5 mL injectable solution
  • Biological: 4CMenB
    All subjects will receive the study vaccine following a 0,2,6 vaccination schedule. Pre-filled syringe, administered by intramuscular injection into the deltoid area of the non dominant arm.
  • Experimental: 4CMenB
    Intervention: Biological: 4CMenB
  • Experimental: MenACWY CRM
    Intervention: Biological: Men ACWY CRM
Kimura A, Toneatto D, Kleinschmidt A, Wang H, Dull P. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine and a quadrivalent meningococcal CRM197 conjugate vaccine against serogroups A, C, W-135, and Y in adults who are at increased risk for occupational exposure to meningococcal isolates. Clin Vaccine Immunol. 2011 Mar;18(3):483-6. doi: 10.1128/CVI.00304-10. Epub 2010 Dec 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy adults,18 through 50 years of age, who are or may be routinely exposed to N. meningitidis cultures

Exclusion Criteria:

  • previous ascertained or suspected disease caused by N. meningitidis;
  • pregnancy or breastfeeding;
  • history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
  • any present or suspected serious acute or chronic disease
  • known or suspected autoimmune disease or impairment /alteration of immune function
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00560313
V72P4, 2007-001563-29
Yes
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Director: Novartis Vaccines Novartis Vaccines
Novartis
December 2011

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