Evaluation of Meningococcal C Vaccine Programmes in Canadian Children

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00936962
First received: July 8, 2009
Last updated: July 14, 2015
Last verified: July 2015
  Purpose
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 Intervention Phase
Meningococcal Sero-type C Infection
Biological: NeisVac C vaccine (12mth)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • To evaluate the longest lasting protection against Meningococcal C disease and to see if a booster vaccination is needed. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 452
Study Start Date: July 2009
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Months to 13 Months
Genders Eligible for Study:   Both
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
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: NCT00936962

Locations
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
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00936962     History of Changes
Other Study ID Numbers: H07-02175 
Study First Received: July 8, 2009
Last Updated: July 14, 2015
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Meningococcal C vaccine
Meningitis study
Canadian vaccine schedule
Prevention of Meningococcal C disease

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016