Effectiveness of H1N1 Influenza Vaccines in Manitoba, Canada

NCT01622491 | Unknown

• 1 other identifier: ICID-2012-H1N1-01
• Study Type: observational
• Target: 1,860
• Locations: 1 country
• Sites: 1

Brief Summary

Excellent immune responses following 1 or 2 doses of the GSK monovalent AS03-adjuvanted pandemic H1N1 (pH1N1) vaccines (e.g., Arepanrix®) have been documented in several trials. Observational studies have found that these vaccines were effective in preventing laboratory confirmed influenza infections. However, it remains unclear whether vaccination during the pandemic was associated with reductions in more clinically meaningful outcomes, such as hospitalizations, severe illness, complications, and death. The investigators propose to evaluate the effectiveness of the GSK adjuvanted and non-adjuvanted pH1N1 vaccines used in Manitoba in preventing hospitalization and severe illness (defined as illness necessitating admission to intensive care or associated with major complications) due to influenza or pneumonia by means of a case-control study using data from Manitoba Health (MH) administrative databases and the database of the Cadham Provincial Laboratory. The primary outcome will be hospitalization with laboratory-confirmed influenza or pneumonia. A secondary outcome will be hospitalization with influenza or pneumonia. The investigators will also assess the effectiveness of the above vaccines for different age groups and among high-risk populations, e.g., immunocompromised individuals.

Conditions

Influenza; Pneumonia

Keywords

H1N1; pandemic; influenza; pneumonia; vaccine; effectiveness; Manitoba; Canada

Outcome Measures

Primary Outcomes (1)

• Hospitalization with laboratory-confirmed influenza or pneumonia

  Data records of hospitalization with laboratory-confirmed influenza or pneumonia

  Three months

Secondary Outcomes (1)

• Hospitalization with influenza or pneumonia

  14 weeks

Study Arms (1)

Case control

A case-control study with cases (individuals hospitalized with influenza or pneumonia during the second wave of the pandemic) and controls (non-hospitalized individuals) identified using the MH Hospital Separation Abstract Database and the MH Population Registry, respectively. Information on receipt of vaccines will be obtained by record linkage to the MIMS.

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any adult or child \> 6 months of age who normally resides in Manitoba and who has been continuously covered during the study period.

Sponsors & Collaborators

• International Centre for Infectious Diseases, Canada: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

International Centre for Infectious Diseases

Winnipeg, Manitoba, R3B 3P5, Canada

Location

MeSH Terms

Conditions

Influenza, Human; Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases

Study Officials

• Salah Mahmud, MD, PhD

  Assistant Professor, University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salah Mahmud, MD, PhD

CONTACT

(204)-940-3611; salah.mahmud@gmail.com

George J Wurtak, MEd

CONTACT

(204)-943-0038; gwurtak@icid.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 19, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: June 19, 2012

Record last verified: 2012-06

Locations

CA (1)