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Evaluation of Meningococcal C Vaccine Programmes in Canadian Children

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ClinicalTrials.gov Identifier: NCT00936962
Recruitment Status : Completed
First Posted : July 10, 2009
Last Update Posted : July 15, 2015
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia

Study Description
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Brief Summary:
The purpose of the study is to see which of the three current provincial Meningococcal C Conjugate vaccine schedules in Canada provide the longest lasting protection against Meningococcal C disease and to see if a booster vaccination is needed.

Condition or disease Intervention/treatment Phase
Meningococcal Sero-type C Infection Biological: NeisVac C vaccine (12mth) Phase 4

Detailed Description:

In 2002-2005, Canada introduced universal MenC programmes consisting of 1,2 or 3 infant doses. Most are one (12 mth) dose. High rates of serogroupC disease in 2000 and 2001 prompted some provinces to launch universal MenC vaccination programmes in 2002. The goal was to provide protection in infancy and early childhood (the time of most risk) with the hope that the protection would extend throughout adolescence (the second highest risk). It is unclear if early multi-dosing or 1 dose programmes would offer better protection (lack of data). Each province in Canada has chosen different Meningococcal C Conjugate vaccine provision schedules for the primary vaccinations.

This study will look at short term protection after the differing provincial series of vaccinations has been given and compare those who do not get primary vaccination under 1 year of age (NS) with two schedules of primary immunization (BC at 2 and 4 mths and Alberta at 2 months). A blood sample will be collected at 12-13 mths for this comparison. A booster vaccination of the current provincial Men C vaccine will be provided at 12 months. Another blood sample will be collected 1 mth later to look at the difference in responses between the groups (different provincial primary vaccination schedule). 2 years and 4 years later (at age 3 and age 5), another blood sample will be collected to look at the difference in long term protection of the groups where the primary schedule was different.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 452 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of Meningococcal C Vaccine Programmes in Canadian (BC, NS, Alta.) Children During Peak Years of Risk (0-<5 Years of Age)
Study Start Date : July 2009
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1 NeisVac C vaccine - 0 doses
NeisVac C (Meningococcal C) vaccine - 0 doses
 Biological: NeisVac C vaccine (12mth)
NeisVac C Meningococcal C Conjugate vaccine given IM 0.5mL in the deltoid muscle at 12 mths of age
Other Names:
  • NeisVac C vaccine (Baxter)
  • Meningococcal C congugate vaccine
Experimental: Group 2 NeiscVac C - 2 doses
2 priming doses of NeisVac C vaccine at 2 and 4 mths of age
 Biological: NeisVac C vaccine (12mth)
NeisVac C Meningococcal C Conjugate vaccine given IM 0.5mL in the deltoid muscle at 12 mths of age
Other Names:
  • NeisVac C vaccine (Baxter)
  • Meningococcal C congugate vaccine
Experimental: Group 3 NeiscVac C - 1 dose
1 priming dose of NeisVac C vaccine at 2 mths of age
 Biological: NeisVac C vaccine (12mth)
NeisVac C Meningococcal C Conjugate vaccine given IM 0.5mL in the deltoid muscle at 12 mths of age
Other Names:
  • NeisVac C vaccine (Baxter)
  • Meningococcal C congugate vaccine


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the longest lasting protection against Meningococcal C disease and to see if a booster vaccination is needed. [ Time Frame: 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   12 Months to 13 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 12-13 mths of age
  • over 34 weeks gestation
  • healthy children
  • having had all vaccinations of Meningococcal C vaccine per the recommended schedule for their respective province within a month of the recommended age - documented.
  • Communication in English

Exclusion Criteria:

  • No contraindication to receiving 12 mth dose of MenC vaccine
  • No other MenC vaccine or MenC disease
Contacts and Locations
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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): NCT00936962


Locations
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Canada, Alberta
Alberta Health Services (Alberta Children's Hospital)
Calgary, Alberta, Canada
Canada, British Columbia
Vaccine Evaluation Center (University of BC at Children's Hospital)
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Canadian Centre for Vaccinology (Dalhousie/IWK,)
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Julie Bettinger, Ph.D University of British Columbia
Study Director: David Scheifele, Ph.D University of British Columbia
Study Director: Scott Halperin, Ph.D Dalhousie University, Halifax
Study Director: James Kellner, Ph.D University of Calgary
More Information
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Additional Information:
click here for information on the trial  This link exits the ClinicalTrials.gov site Click here for interim analysis publication  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00936962    
Other Study ID Numbers: H07-02175
First Posted: July 10, 2009    Key Record Dates
Last Update Posted: July 15, 2015
Last Verified: July 2015
Keywords provided by University of British Columbia:
Meningococcal C vaccine
Meningitis study
Canadian vaccine schedule
Prevention of Meningococcal C disease
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs