Evaluation of Meningococcal C Vaccine Programmes in Canadian Children

July 14, 2015 updated by: University of British Columbia

Evaluation of Meningococcal C Vaccine Programmes in Canadian (BC, NS, Alta.) Children During Peak Years of Risk (0-<5 Years of Age)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

452

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Alberta Health Services (Alberta Children's Hospital)
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vaccine Evaluation Center (University of BC at Children's Hospital)
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Canadian Centre for Vaccinology (Dalhousie/IWK,)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 8, 2009

First Submitted That Met QC Criteria

July 9, 2009

First Posted (Estimate)

July 10, 2009

Study Record Updates

Last Update Posted (Estimate)

July 15, 2015

Last Update Submitted That Met QC Criteria

July 14, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H07-02175

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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