Evaluation of Meningococcal C Vaccine Programmes in Canadian Children

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Meningococcal Sero-type C Infection

Intervention / Treatment
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* Biological: NeisVac C vaccine (12mth)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 13 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 NeisVac C vaccine - 0 doses<br>NeisVac C (Meningococcal C) vaccine - 0 doses | Biological: NeisVac C vaccine (12mth)<br>* NeisVac C Meningococcal C Conjugate vaccine given IM 0.5mL in the deltoid muscle at 12 mths of age<br>* Other names: Meningococcal C congugate vaccine;|
| Experimental: Group 2 NeiscVac C - 2 doses<br>2 priming doses of NeisVac C vaccine at 2 and 4 mths of age | Biological: NeisVac C vaccine (12mth)<br>* NeisVac C Meningococcal C Conjugate vaccine given IM 0.5mL in the deltoid muscle at 12 mths of age<br>* Other names: Meningococcal C congugate vaccine;|
| Experimental: Group 3 NeiscVac C - 1 dose<br>1 priming dose of NeisVac C vaccine at 2 mths of age | Biological: NeisVac C vaccine (12mth)<br>* NeisVac C Meningococcal C Conjugate vaccine given IM 0.5mL in the deltoid muscle at 12 mths of age<br>* Other names: Meningococcal C congugate vaccine;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningococcal C vaccine, Meningitis study, Canadian vaccine schedule, Prevention of Meningococcal C disease