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Trial record 6 of 19 for:    Vaccine | Meningococcal | Canada

Evaluation of Meningococcal ACWY Immune Response in Children Aged 40 and 60 Months

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00601731
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : September 19, 2012
Last Update Posted : October 24, 2014
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Tracking Information
First Submitted Date  ICMJE January 15, 2008
First Posted Date  ICMJE January 28, 2008
Results First Submitted Date  ICMJE October 28, 2011
Results First Posted Date  ICMJE September 19, 2012
Last Update Posted Date October 24, 2014
Study Start Date  ICMJE February 2008
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2012)
Percentage of Subjects With hSBA ≥1:8 [ Time Frame: At 40 and 60 months of age ]
Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2008)
Immunogenicity as measured by serum bactericidal activity at 40 months and 60 months of age [ Time Frame: 40 and 60 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2012)
  • Percentage of Subjects With hSBA ≥1:4 [ Time Frame: At 40 and 60 months of age ]
    Percentages of subjects with hSBA ≥1:4 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
  • GMTs in Subjects Within Each Site and in Age-Matched Control Subjects [ Time Frame: At 40 and 60 months of age ]
    The Geometric Mean Titers (GMTs) as measured by serum bactericidal activity at 40 months and 60 months of age and 95% CIs were calculated for each vaccine group and for each serogroup by exponentiating (base 10) the least square means of the logarithmically transformed (base 10) titers and their 95% CIs obtained from a two-way Analysis of Variance (ANOVA) with factors for vaccine group and center.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2008)
Safety [ Time Frame: 40 and 60 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Meningococcal ACWY Immune Response in Children Aged 40 and 60 Months
Official Title  ICMJE A Phase 2, Open-label, Controlled, Multi-center Study to Evaluate Meningococcal ACWY Antibody Response in Children Aged 40 and 60 Months Who Have Previously Received Novartis MenACWY Conjugate Vaccine as Infants
Brief Summary The purpose of this study is to evaluate how well the immuno response against meningococcal serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Meningococcal Disease
Intervention  ICMJE
  • Biological: MenACWY-CRM197
    Blood test, 40-months and 60-months children
  • Biological: Blood test
    Blood test, 40-months and 60-months children
Study Arms  ICMJE
  • Experimental: Adjuvanted MenACWY vaccine group
    Blood test
    Intervention: Biological: MenACWY-CRM197
  • Active Comparator: Non-adjuvanted MenACWY vaccine group
    Blood test
    Intervention: Biological: Blood test
Publications * Khatami A, Snape MD, Davis E, Layton H, John T, Yu LM, Dull PM, Gill CJ, Odrjlin T, Dobson S, Halperin SA, Langley JM, McNeil SA, Pollard AJ. Persistence of the immune response at 5 years of age following infant immunisation with investigational quadrivalent MenACWY conjugate vaccine formulations. Vaccine. 2012 Apr 16;30(18):2831-8. doi: 10.1016/j.vaccine.2012.02.046. Epub 2012 Mar 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2012)
382
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2008)
475
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Follow-on, healthy 40, 60 months old participants who have completed the V59P5 study and are in good health
  • Control subjects: healthy 60 months old who had received a complete MenC immunization course

Exclusion Criteria:

  • Subjects with any serious, acute or chronic progressive disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Months to 63 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00601731
Other Study ID Numbers  ICMJE V59P5E1
2007-004978-16
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Vaccines )
Study Sponsor  ICMJE Novartis Vaccines
Collaborators  ICMJE Novartis
Investigators  ICMJE
Study Chair: Novartis Vaccines Novartis Vaccines
PRS Account Novartis
Verification Date October 2014

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