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Completed

NCT Number: NCT00936962

Evaluation of Meningococcal C Vaccine Programmes in Canadian Children

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.

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Key information

Age range

12 month–13 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alberta Health Services (Alberta Children's Hospital), Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeisVac C vaccine (12mth)

Biological

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

Primary outcomes

  1. To evaluate the longest lasting protection against Meningococcal C disease and to see if a booster vaccination is needed.

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2009
Registry last updated
Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.