Clinical trial NCT00936962: Evaluation of Meningococcal C Vaccine Programmes in Canadian Children
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meningococcal Sero-type C Infection
Keywords: Meningococcal C vaccine
Meningitis study
Canadian vaccine schedule
Prevention of Meningococcal C disease
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2009-07-10
Enrollment: 452
Sex: ALL
Minimum age (years): 12
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.

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 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

Primary outcomes:
measure: To evaluate the longest lasting protection against Meningococcal C disease and to see if a booster vaccination is needed.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Health Services (Alberta Children's Hospital)
state: Alberta
city: Vancouver
country: Canada
facility: Vaccine Evaluation Center (University of BC at Children's Hospital)
state: British Columbia
city: Halifax
country: Canada
facility: Canadian Centre for Vaccinology (Dalhousie/IWK,)
state: Nova Scotia
Study officials:
affiliation: University of British Columbia
name: Julie Bettinger, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: David Scheifele, Ph.D
role: STUDY_DIRECTOR
affiliation: Dalhousie University, Halifax
name: Scott Halperin, Ph.D
role: STUDY_DIRECTOR
affiliation: University of Calgary
name: James Kellner, Ph.D
role: STUDY_DIRECTOR
References:
citation: Bettinger JA, Scheifele DW, Halperin SA, Kellner JD, Vanderkooi OG, Schryvers A, De Serres G, Alcantara J. Evaluation of meningococcal serogroup C conjugate vaccine programs in Canadian children: interim analysis. Vaccine. 2012 Jun 8;30(27):4023-7. doi: 10.1016/j.vaccine.2012.04.034. Epub 2012 Apr 23.