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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00601731
First received: January 15, 2008
Last updated: September 17, 2012
Last verified: September 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

Primary Outcome Measures:
  • Percentage of Subjects With hSBA ≥1:8 [ Time Frame: At 40 and 60 months of age ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   40 Months to 63 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00601731     History of Changes
Other Study ID Numbers: V59P5E1, 2007-004978-16
Study First Received: January 15, 2008
Results First Received: October 28, 2011
Last Updated: September 17, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Prevention of Meningococcal disease

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 18, 2014