Adjuvanted Influenza Vaccine Effectiveness in the Elderly (65+Yrs)

Fraser Health

Status: Unknown

Conditions: Influenza

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01424371

2011-071

Details and patient eligibility

About

This study explores the hypothesis that the use of an adjuvanted influenza vaccine in the elderly will produce greater vaccine effectiveness in their group.

Full description

To evaluate the effectiveness of adjuvanted trivalent inactivated influenza vaccine in the elderly (aged ≥ 65 years) through the reduction in relative risk of microbiologically confirmed influenza illness

Enrollment: 1,000 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1.Elderly tested for influenza as part of routine clinical care in the Lower Mainland and on Vancouver Island during the influenza season.

Cases: Proven influenza diagnosed on naso-pharyngeal swab via PCR Controls: Elderly with influenza-like-illness testing negative for influenza during the influenza season.

Exclusion criteria

1. Known immunodeficiency disorders (including HIV)
2. Current or recent (within 90 days prior to first dose of influenza vaccine) immunosuppressive treatment including chronic oral steroids (1mg/kg for > 4 weeks), cytotoxic chemotherapy, radiation therapy, other immunosuppressive drug and biologic agents Note: Use of topical or inhalant corticosteroids is acceptable.
3. Administration of immunoglobulins during the study period;

Trial design

1,000 participants in 3 patient groups

Adjuvanted Vaccine Group

Unadjuvanted Vaccine Group

Unvaccinated Elderly