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Evaluation of Meningococcal C Vaccine Programmes in Canadian Children

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00936962
Enrollment
452
Registered
2009-07-10
Start date
2009-07-31
Completion date
2015-06-30
Last updated
2015-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningococcal Sero-type C Infection

Keywords

Meningococcal C vaccine, Meningitis study, Canadian vaccine schedule, Prevention of Meningococcal C disease

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.

Interventions

BIOLOGICALNeisVac C vaccine (12mth)

NeisVac C Meningococcal C Conjugate vaccine given IM 0.5mL in the deltoid muscle at 12 mths of age

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Months to 13 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
To evaluate the longest lasting protection against Meningococcal C disease and to see if a booster vaccination is needed.4 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026