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

NCT01694329 | Unknown

• 1 other identifier: GSK114180
• Study Type: observational
• Target: 1,420
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

Streptococcus pneumoniae; Pneumococcal Conjugate Vaccines; Immunization; Otitis media

Outcome Measures

Primary Outcomes (1)

• Prevalence of anatomical and functional lesions of the middle ear at the age of 5 years.

  at age of 5 years old

Secondary Outcomes (7)

• 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

Study Arms (1)

2006-2010 cohort

cohort of children born between 2006 and 2010, and living in Nunavik

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Centre de recherche du CHUQ

Québec, Quebec, G1R 3L5, Canada

Location

Related Publications (3)

• 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.

  PMID: 32730119 DERIVED

• 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.

  PMID: 30924406 DERIVED

• 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.

  PMID: 30026032 DERIVED

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Philippe De Wals, MD PhD

  Centre de recherche du CHUQ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2012
• First Posted: September 27, 2012
• Study Start: September 1, 2012
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 3, 2017

Record last verified: 2015-10

Locations

CA (1)