Evaluation of Meningococcal C Vaccine Programmes in Canadian Children
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| ClinicalTrials.gov Identifier: NCT00936962 |
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Recruitment Status
:
Completed
First Posted
: July 10, 2009
Last Update Posted
: July 15, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Meningococcal Sero-type C Infection | Biological: NeisVac C vaccine (12mth) | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 452 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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) |
| Study Start Date : | July 2009 |
| Actual Primary Completion Date : | June 2015 |
| Actual Study Completion Date : | June 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group 1 NeisVac C vaccine - 0 doses
NeisVac C (Meningococcal C) vaccine - 0 doses
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Biological: NeisVac C vaccine (12mth)
NeisVac C Meningococcal C Conjugate vaccine given IM 0.5mL in the deltoid muscle at 12 mths of age
Other Names:
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Experimental: Group 2 NeiscVac C - 2 doses
2 priming doses of NeisVac C vaccine at 2 and 4 mths of age
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Biological: NeisVac C vaccine (12mth)
NeisVac C Meningococcal C Conjugate vaccine given IM 0.5mL in the deltoid muscle at 12 mths of age
Other Names:
|
|
Experimental: Group 3 NeiscVac C - 1 dose
1 priming dose of NeisVac C vaccine at 2 mths of age
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Biological: NeisVac C vaccine (12mth)
NeisVac C Meningococcal C Conjugate vaccine given IM 0.5mL in the deltoid muscle at 12 mths of age
Other Names:
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- To evaluate the longest lasting protection against Meningococcal C disease and to see if a booster vaccination is needed. [ Time Frame: 4 years ]
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| Ages Eligible for Study: | 12 Months to 13 Months (Child) |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936962
| 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 |
Additional Information:
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 |
| First Posted: | July 10, 2009 Key Record Dates |
| Last Update Posted: | July 15, 2015 |
| Last Verified: | July 2015 |
Keywords provided by University of British Columbia:
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Meningococcal C vaccine Meningitis study Canadian vaccine schedule Prevention of Meningococcal C disease |
Additional relevant MeSH terms:
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Vaccines Immunologic Factors Physiological Effects of Drugs |