Impact of Introduction of PHiD-CV for Nunavik Children, Quebec, Canada (Nunavik2)

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

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).

Study Overview

• Status: Unknown
• Conditions: Acute Upper Respiratory Infection; Acute Lower Respiratory Tract Infection; Invasive Pneumococcal Disease, Protection Against; Otitis Media (OM)

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 1420

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Quebec City, Quebec, Canada, G1R 3L5
      • Centre de recherche du CHUQ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children of Nunavik born between 2006 and 2010, who have been exposed to PHiD-CV in combination with PCV-7 or PCV-13

Description

Inclusion Criteria:

• Born between 2006 and 2010
• Resident in Nunavik (province of Quebec, Canada)

Exclusion Criteria:

• Not applicable

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
2006-2010 cohort; cohort of children born between 2006 and 2010, and living in Nunavik

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Philippe De Wals, MD PhD, Centre de recherche du CHUQ

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): December 31, 2017

Study Registration Dates

• First Submitted: June 8, 2012
• First Submitted That Met QC Criteria: September 25, 2012
• First Posted (Estimate): September 27, 2012

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: March 1, 2017
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Immunization; Streptococcus pneumoniae; Otitis media; Pneumococcal Conjugate Vaccines
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Otorhinolaryngologic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Ear Diseases; Infections; Communicable Diseases; Pneumococcal Infections; Otitis; Otitis Media; Respiratory Tract Infections
• Other Study ID Numbers: GSK114180