Impact of Introduction of PHiD-CV for Nunavik Children, Quebec, Canada (Nunavik2)
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|ClinicalTrials.gov Identifier: NCT01694329|
Recruitment Status : Unknown
Verified October 2015 by CHU de Quebec-Universite Laval.
Recruitment status was: Active, not recruiting
First Posted : September 27, 2012
Last Update Posted : March 3, 2017
|Condition or disease|
|Acute Upper Respiratory Infection Acute Lower Respiratory Tract Infection Otitis Media (OM) Invasive Pneumococcal Disease, Protection Against|
Around 1420 children born between 2006 and 2010 had been eligible to routine immunization program with pneumococcal vaccines.
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:
- the incidence of invasive pneumococcal disease(IPD), AURIs, ALRIs and OMs;
- the frequency of antibiotic treatments due to these diseases;
- the frequency of hospitalizations and transfers to the South on account of ALRIs;
- the frequency of tympanotomies and ventilation tube insertions;
- 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.
|Study Type :||Observational|
|Actual Enrollment :||1420 participants|
|Official Title:||Impact of Introduction of PHiD-CV (Pneumococcal Nontypeable H. Influenza Protein D-conjugate Vaccine) for Nunavik Children, Quebec, Canada|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||December 31, 2017|
|Estimated Study Completion Date :||December 31, 2017|
cohort of children born between 2006 and 2010, and living in Nunavik
- Prevalence of anatomical and functional lesions of the middle ear at the age of 5 years. [ Time Frame: at age of 5 years old ]
- Incidence of IPDs [ Time Frame: at age of 5 years old ]
- Frequency of antibiotic treatments due to diseases of interest [ Time Frame: at age of 5 years old ]
- Frequency of hospitalizations and transfers to the South on account of ALRIs [ Time Frame: at age of 5 years old ]
- Frequency of tympanotomies and ventilation tube insertions [ Time Frame: at age of 5 years old ]
- Incidence of AURIs [ Time Frame: at age of 5 years old ]
- Incidence of ALRIs [ Time Frame: at age of 5 years old ]
- Incidence of OMs [ Time Frame: at age of 5 years old ]
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): NCT01694329
|Centre de recherche du CHUQ|
|Quebec City, Quebec, Canada, G1R 3L5|
|Principal Investigator:||Philippe De Wals, MD PhD||Centre de recherche du CHUQ|