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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00601731
First Posted: January 28, 2008
Last Update Posted: October 24, 2014
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.
Collaborator:
Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
  Purpose
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.

Condition Intervention Phase
Meningococcal Disease Biological: MenACWY-CRM197 Biological: Blood test Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Vaccines ):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 382
Study Start Date: February 2008
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adjuvanted MenACWY vaccine group
Blood test
Biological: MenACWY-CRM197
Blood test, 40-months and 60-months children
Active Comparator: Non-adjuvanted MenACWY vaccine group
Blood test
Biological: Blood test
Blood test, 40-months and 60-months children

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Months to 63 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601731


Locations
Canada
Clinical Trials Research Center
Halifax, Canada
Vaccine Evaluation Center
Vancouver, Canada
United Kingdom
Oxford Vaccine Group
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Novartis Vaccines
Novartis
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00601731     History of Changes
Other Study ID Numbers: V59P5E1
2007-004978-16
First Submitted: January 15, 2008
First Posted: January 28, 2008
Results First Submitted: October 28, 2011
Results First Posted: September 19, 2012
Last Update Posted: October 24, 2014
Last Verified: October 2014

Keywords provided by Novartis ( Novartis Vaccines ):
Prevention of Meningococcal disease

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs