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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by Centre Hospitalier Universitaire de Québec, CHU de Québec
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT01694329
First received: June 8, 2012
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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).


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Introduction of PHiD-CV (Pneumococcal Nontypeable H. Influenza Protein D-conjugate Vaccine) for Nunavik Children, Quebec, Canada

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • Prevalence of anatomical and functional lesions of the middle ear at the age of 5 years. [ Time Frame: at age of 5 years old ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of IPDs [ Time Frame: at age of 5 years old ] [ Designated as safety issue: No ]
  • Frequency of antibiotic treatments due to diseases of interest [ Time Frame: at age of 5 years old ] [ Designated as safety issue: No ]
  • Frequency of hospitalizations and transfers to the South on account of ALRIs [ Time Frame: at age of 5 years old ] [ Designated as safety issue: No ]
  • Frequency of tympanotomies and ventilation tube insertions [ Time Frame: at age of 5 years old ] [ Designated as safety issue: No ]
  • Incidence of AURIs [ Time Frame: at age of 5 years old ] [ Designated as safety issue: No ]
  • Incidence of ALRIs [ Time Frame: at age of 5 years old ] [ Designated as safety issue: No ]
  • Incidence of OMs [ Time Frame: at age of 5 years old ] [ Designated as safety issue: No ]

Estimated Enrollment: 1420
Study Start Date: September 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
2006-2010 cohort
cohort of children born between 2006 and 2010, and living in Nunavik

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.

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Not applicable

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694329

Locations
Canada, Quebec
Centre de recherche du CHUQ Not yet recruiting
Quebec City, Quebec, Canada, G1R 3L5
Contact: Philippe De Wals, MD PhD    418-666-7000 ext 363    martine.six@ssss.gouv.qc.ca   
Principal Investigator: Philippe De Wals, MD PhD         
Sub-Investigator: Jean-François Proulx, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
GlaxoSmithKline
Investigators
Principal Investigator: Philippe De Wals, MD PhD Centre de recherche du CHUQ
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier: NCT01694329     History of Changes
Other Study ID Numbers: GSK114180
Study First Received: June 8, 2012
Last Updated: September 25, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
Streptococcus pneumoniae
Pneumococcal Conjugate Vaccines
Immunization
Otitis media

Additional relevant MeSH terms:
Communicable Diseases
Infection
Otitis Media
Respiratory Tract Infections
Ear Diseases
Otitis
Otorhinolaryngologic Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 22, 2014