Clinical trial NCT01694329: Impact of Introduction of PHiD-CV for Nunavik Children, Quebec, Canada
Official title: Impact of Introduction of PHiD-CV (Pneumococcal Nontypeable H. Influenza Protein D-conjugate Vaccine) for Nunavik Children, Quebec, Canada
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2012-09-27
Enrollment: 1420
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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).

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

• Not applicable

Primary outcomes:
measure: Prevalence of anatomical and functional lesions of the middle ear at the age of 5 years.
timeFrame: at age of 5 years old
Secondary outcomes:
measure: Incidence of IPDs
timeFrame: at age of 5 years old
measure: Frequency of antibiotic treatments due to diseases of interest
timeFrame: at age of 5 years old
measure: Frequency of hospitalizations and transfers to the South on account of ALRIs
timeFrame: at age of 5 years old
measure: Frequency of tympanotomies and ventilation tube insertions
timeFrame: at age of 5 years old
measure: Incidence of AURIs
timeFrame: at age of 5 years old
measure: Incidence of ALRIs
timeFrame: at age of 5 years old
measure: Incidence of OMs
timeFrame: at age of 5 years old
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Centre de recherche du CHUQ
state: Quebec
Study officials:
affiliation: Centre de recherche du CHUQ
name: Philippe De Wals, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.