Overview

This trial is active, not recruiting.

Conditions acute upper respiratory infection, acute lower respiratory tract infection, otitis media (om), invasive pneumococcal disease, protection against
Sponsor Centre Hospitalier Universitaire de Québec, CHU de Québec
Collaborator GlaxoSmithKline
Start date September 2012
End date September 2016
Trial size 1420 participants
Trial identifier NCT01694329, GSK114180

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
cohort of children born between 2006 and 2010, and living in Nunavik

Primary Outcomes

Measure
Prevalence of anatomical and functional lesions of the middle ear at the age of 5 years.
time frame: at age of 5 years old

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants up to 5 years old.

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

Additional Information

Official title Impact of Introduction of PHiD-CV (Pneumococcal Nontypeable H. Influenza Protein D-conjugate Vaccine) for Nunavik Children, Quebec, Canada
Principal investigator Philippe De Wals, MD PhD
Description 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: 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Québec, CHU de Québec.