Impact of Introduction of PHiD-CV for Nunavik Children, Q... | NCT01694329

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

NCT01694329

Sponsor

CHU de Quebec-Universite Laval

Status

Unknown status

Last Update Posted

Mar 3, 2017Actual

Enrollment

1,420Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Dec 31, 2017Estimated

Completion Date

Dec 31, 2017Estimated

First Submitted Date

Jun 8, 2012

First Submission Date that Met QC Criteria

Sep 25, 2012

First Posted Date

Sep 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2017

Last Update Posted Date

Mar 3, 2017Actual

Name	Class
GlaxoSmithKline	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,420Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2006-2010 cohort		cohort of children born between 2006 and 2010, and living in Nunavik

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of anatomical and functional lesions of the middle ear at the age of 5 years.		at age of 5 years old

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Not applicable

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

5 Years

Standard Ages

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe De Wals, MD PhD	Centre de recherche du CHUQ	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre de recherche du CHUQ		Québec	Quebec	G1R 3L5	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32730119	Derived	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.
30924406	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.

Type	Date	Date Unknown
Release	Sep 23, 2019
Reset	Oct 11, 2019

ID	Term
D010031	Otitis
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases