Impact of Introduction of PHiD-CV for Nunavik Children, Quebec, Canada (Nunavik2)
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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 |
- 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 ]
- 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:
- the incidence of invasive pneumococcal disease(IPD), AURIs, ALRIs and OMs;
- the frequency of antibiotic treatments due to these diseases;
- the frequency of hospitalizations and transfers to the South on account of ALRIs;
- the frequency of tympanotomies and ventilation tube insertions;
- 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 |
Children of Nunavik born between 2006 and 2010, who have been exposed to PHiD-CV in combination with PCV-7 or PCV-13
Inclusion Criteria:
- Born between 2006 and 2010
- Resident in Nunavik (province of Quebec, Canada)
Exclusion Criteria:
• Not applicable
Contacts and 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 | |
| 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:
|
Common Cold Otitis Otitis Media Respiratory Tract Infections Ear Diseases Otorhinolaryngologic Diseases |
Infection Respiratory Tract Diseases Picornaviridae Infections RNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 19, 2013