Impact of Introduction of PHiD-CV for Nunavik Children, Quebec, Canada
NCT ID: NCT01694329
Last Updated: 2017-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1420 participants
OBSERVATIONAL
2012-09-30
2017-12-31
Brief Summary
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Detailed Description
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The objective of this study is to document the residual burden of acute upper respiratory infections (AURIs), acute lower respiratory infections (ALRIs), otitis media (OMs) and auditory functional and anatomical abnormalities in children under the age of 5 years in Nunavik who will be exposed to PHiD-CV in combination with PCV-7 or PCV-13. The comparison groups will be the cohorts of children who received no PCV vaccine (those born in 1994-1996) and those exposed to PCV-7 exclusively (those born in 2003-2007).
The specific objectives are to measure in children under the age of 5 years in Nunavik and born in the period 2009 to 2010:
1. the incidence of invasive pneumococcal disease(IPD), AURIs, ALRIs and OMs;
2. the frequency of antibiotic treatments due to these diseases;
3. the frequency of hospitalizations and transfers to the South on account of ALRIs;
4. the frequency of tympanotomies and ventilation tube insertions;
5. the prevalence of anatomical and functional lesions of the middle ear at the age of 5 years (the main issue).
The main research hypothesis is that the incidence of AURIs, ALRIs and OMs and the prevalence of sequelae from OM decreased after the implementation of PHiD-CV in 2009, as compared with previous cohorts of children who were not exposed to this new vaccine.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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2006-2010 cohort
cohort of children born between 2006 and 2010, and living in Nunavik
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Resident in Nunavik (province of Quebec, Canada)
Exclusion Criteria
5 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
CHU de Quebec-Universite Laval
OTHER
Responsible Party
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Principal Investigators
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Philippe De Wals, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Centre de recherche du CHUQ
Locations
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Centre de recherche du CHUQ
Québec, Quebec, Canada
Countries
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References
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De Wals P, Zhou Z, LeMeur JB, Proulx JF. Burden of respiratory infections and otitis media in the Inuit population of Nunavik, Quebec, Canada. Int J Circumpolar Health. 2020 Dec;79(1):1799688. doi: 10.1080/22423982.2020.1799688.
De Wals P, Lemeur JB, Ayukawa H, Proulx JF. Middle ear abnormalities at age 5 years in relation with early onset otitis media and number of episodes, in the Inuit population of Nunavik, Quebec, Canada. Int J Circumpolar Health. 2019 Dec;78(1):1599269. doi: 10.1080/22423982.2019.1599269.
Le Meur JB, Ayukawa H, Proulx JF, De Wals P. Prevalence of middle ear abnormalities from otitis media in relation with pneumococcal vaccine use in the Inuit population of Nunavik, province of Quebec, Canada. Vaccine. 2018 Aug 16;36(34):5180-5186. doi: 10.1016/j.vaccine.2018.07.008. Epub 2018 Jul 17.
Other Identifiers
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GSK114180
Identifier Type: -
Identifier Source: org_study_id
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