Impact of Introduction of PHiD-CV for Nunavik Children, Quebec, Canada

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Impact of Introduction of PHiD-CV (Pneumococcal Nontypeable H. Influenza Protein D-conjugate Vaccine) for Nunavik Children, Quebec, Canada

Conditions
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Acute Upper Respiratory Infection, Acute Lower Respiratory Tract Infection, Otitis Media (OM), Invasive Pneumococcal Disease, Protection Against

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Born between 2006 and 2010 Resident in Nunavik (province of Quebec, Canada) Exclusion Criteria: • Not applicable

Ages Eligible for Study
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Maximum Age: 5 Years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 2006-2010 cohort<br>cohort of children born between 2006 and 2010, and living in Nunavik | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of anatomical and functional lesions of the middle ear at the age of 5 years. |  | at age of 5 years old | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of IPDs |  | at age of 5 years old | 
| Frequency of antibiotic treatments due to diseases of interest |  | at age of 5 years old | 
| Frequency of hospitalizations and transfers to the South on account of ALRIs |  | at age of 5 years old | 
| Frequency of tympanotomies and ventilation tube insertions |  | at age of 5 years old | 
| Incidence of AURIs |  | at age of 5 years old | 
| Incidence of ALRIs |  | at age of 5 years old | 
| Incidence of OMs |  | at age of 5 years old | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Streptococcus pneumoniae, Pneumococcal Conjugate Vaccines, Immunization, Otitis media