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

Impact of Introduction of PHiD-CV (Pneumococcal Nontypeable H. Influenza Protein D-conjugate Vaccine) for Nunavik Children, Quebec, Canada

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01694329

Acronym

Nunavik2

Enrollment

1420

Registered

2012-09-27

Start date

2012-09-30

Completion date

2017-12-31

Last updated

2017-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Streptococcus pneumoniae, Pneumococcal Conjugate Vaccines, Immunization, Otitis media

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 5 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

• Not applicable

Design outcomes

Primary

Measure	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

Measure	Time frame
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	at age of 5 years old
Frequency of tympanotomies and ventilation tube insertions	at age of 5 years old
Incidence of IPDs	at age of 5 years old
Incidence of ALRIs	at age of 5 years old
Incidence of OMs	at age of 5 years old
Incidence of AURIs	at age of 5 years old

Countries

Canada

Outcome results