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

Acute Upper Respiratory Infection Clinical Trial

— Nunavik2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01694329
• Other study ID #: GSK114180
• Status: Active, not recruiting
• Phase: N/A
• First received: June 8, 2012
• Last updated: March 1, 2017
• Start date: September 2012
• Est. completion date: December 31, 2017

Study information

• Verified date: October 2015
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1420
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

• Born between 2006 and 2010

• Resident in Nunavik (province of Quebec, Canada)

Exclusion Criteria:

• Not applicable

Related Conditions & MeSH terms

• Acute Lower Respiratory Tract Infection
• Acute Upper Respiratory Infection
• Communicable Diseases
• Infection
• Invasive Pneumococcal Disease, Protection Against
• Otitis
• Otitis Media
• Otitis Media (OM)
• Pneumococcal Infections
• Respiratory Tract Infections

Locations

Country	Name	City	State
Canada	Centre de recherche du CHUQ	Quebec City	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec	GlaxoSmithKline

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of anatomical and functional lesions of the middle ear at the age of 5 years.		at age of 5 years old
Secondary	Incidence of IPDs		at age of 5 years old
Secondary	Frequency of antibiotic treatments due to diseases of interest		at age of 5 years old
Secondary	Frequency of hospitalizations and transfers to the South on account of ALRIs		at age of 5 years old
Secondary	Frequency of tympanotomies and ventilation tube insertions		at age of 5 years old
Secondary	Incidence of AURIs		at age of 5 years old
Secondary	Incidence of ALRIs		at age of 5 years old
Secondary	Incidence of OMs		at age of 5 years old