Acute Upper Respiratory InfectionNunavik2NCT01694329
Impact of Introduction of PHiD-CV for Nunavik Children, Quebec, Canada
An observational study of Acute Upper Respiratory Infection and Acute Lower Respiratory Tract Infection, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Upper Respiratory Infection, Acute Lower Respiratory Tract Infection, Otitis Media (OM)
- How many people
- 1,420 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- Born between 2006 and 2010
- Resident in Nunavik (province of Quebec, Canada)
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- 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
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 2006-2010 cohort | cohort of children born between 2006 and 2010, and living in Nunavik |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anatomical and functional lesions of the middle ear at the age of 5 years.
Measured: at age of 5 years old
Secondary outcomes (7)
Incidence of IPDs
Measured: at age of 5 years old
Frequency of antibiotic treatments due to diseases of interest
Measured: at age of 5 years old
Frequency of hospitalizations and transfers to the South on account of ALRIs
Measured: at age of 5 years old
Frequency of tympanotomies and ventilation tube insertions
Measured: at age of 5 years old
Incidence of AURIs
Measured: at age of 5 years old
Incidence of ALRIs
Measured: at age of 5 years old
Incidence of OMs
Measured: at age of 5 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startSep 2012
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Upper Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,420 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Philippe De Wals, MD PhD, Principal investigator, Centre de recherche du CHUQ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694329
- Sponsor's protocol ID
- GSK114180
- Acronym
- Nunavik2
- Status last verified
- Oct 2015
- First submitted
- 8 Jun 2012
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32730119De 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.
PubMed 30924406Le 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.
PubMed 30026032
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Introduction of PHiD-CV (Pneumococcal Nontypeable H. Influenza Protein D-conjugate Vaccine) for Nunavik Children, Quebec, Canada
- ClinicalTrials.gov ID
- NCT01694329
- Acronym / sponsor ID
- Nunavik2 / GSK114180
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,420 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 2012
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2006-2010 cohort | – | –cohort of children born between 2006 and 2010, and living in Nunavik |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- Born between 2006 and 2010
- Resident in Nunavik (province of Quebec, Canada)
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of anatomical and functional lesions of the middle ear at the age of 5 years.
Time frame: at age of 5 years old
7 secondary outcomes
Incidence of IPDs
Time frame: at age of 5 years old
Frequency of antibiotic treatments due to diseases of interest
Time frame: at age of 5 years old
Frequency of hospitalizations and transfers to the South on account of ALRIs
Time frame: at age of 5 years old
Frequency of tympanotomies and ventilation tube insertions
Time frame: at age of 5 years old
Incidence of AURIs
Time frame: at age of 5 years old
Incidence of ALRIs
Time frame: at age of 5 years old
Incidence of OMs
Time frame: at age of 5 years old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Derived from this study: PubMed 32730119De 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.
- Derived from this study: PubMed 30924406De 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.
- Derived from this study: PubMed 30026032Le 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe De Wals, MD PhD principal investigator
Centre de recherche du CHUQ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Upper Respiratory Infection and Acute Lower Respiratory Tract Infection, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anatomical and functional lesions of the middle ear at the age of 5 years. (time frame: at age of 5 years old). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01694329, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.