Evaluation of Meningococcal C Vaccine Programmes in Canadian Children
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningococcal C Disease |
Biological: Neisvac-C (Meningococcal C Conjugate Vaccine) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Evaluation of Meningococcal C Vaccine Programmes in Canadian (BC, NS, Alta.) Children During Peak Years of Risk (0-<5 Years of Age) |
- To evaluate the longest lasting protection against Meningococcal C disease and to see if a booster vaccination is needed. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 465 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Group 1 will have had no Meningococcal C vaccine <1 year pf age
|
|
|
Experimental: 2
Group 2 will have had 2 priming doses of Meningococcal C vaccine (2 and 4 mths of age)
|
Biological: Neisvac-C (Meningococcal C Conjugate Vaccine)
Doses of NeisVac C Meningococcal C Conjugate vaccine given IM 0.5mL in the deltoid
Other Name: NeisVac C vaccine (Baxter)
|
|
Experimental: 3
Group 3 will have had 1 priming dose of Meningococcal C vaccine (2 mths of age)
|
Biological: Neisvac-C (Meningococcal C Conjugate Vaccine)
Doses of NeisVac C Meningococcal C Conjugate vaccine given IM 0.5mL in the deltoid
Other Name: NeisVac C vaccine (Baxter)
|
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 programes 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| Ages Eligible for Study: | 12 Months to 13 Months |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Canada, Alberta | |
| Alberta Health Services (Alberta Children's Hospital) | |
| Calgary, Alberta, Canada | |
| Canada, British Columbia | |
| Vaccine Evaluation Center (University of BC at Children's Hospital) | |
| Vancouver, British Columbia, Canada | |
| Canada, Nova Scotia | |
| Canadian Centre for Vaccinology (Dalhousie/IWK,) | |
| Halifax, Nova Scotia, Canada | |
| 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 |
More Information
Additional Information:
No publications provided by University of British Columbia
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00936962 History of Changes |
| Other Study ID Numbers: | H07-02175 |
| Study First Received: | July 8, 2009 |
| Last Updated: | March 9, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
Meningococcal C vaccine Meningitis study Canadian vaccine schedule Prevention of Meningococcal C disease |
ClinicalTrials.gov processed this record on May 16, 2013