Clinical Trials Logo
  1. Home
  2. Influenza
  3. NCT00306982
  4. Details
NCT00306982 Clinical Trial

Incidence of Influenza, Downstream Complications of Influenza & Hospitalizations in Elderly Vaccinated With Fluarix™

Influenza Clinical Trial

Official title:
An Observational Study to Investigate the Incidence of Influenza, Downstream Complications of Influenza and Hospitalizations, in Elderly Subjects Vaccinated With GSK Biologicals' Influenza Vaccine (Fluarix™) Administered Intramuscularly.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00306982
Other study ID # 106622
Secondary ID
Status Completed
Phase N/A
First received February 27, 2006
Last updated October 11, 2016
Start date March 2006
Est. completion date December 2006

Study information
Verified date October 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Observational

Clinical Trial Summary

This study will investigate the incidence of influenza, disease and various possible downstream complications and hospitalizations or emergency room visits after routine annual vaccination of the elderly population with Fluarix™.

Description:

This study will investigate the incidence of influenza, disease and various possible downstream complications, such as pneumonia, ischemic HD (unstable angina or MI), congestive heart failure, acute cerebrovascular disease, COPD exacerbation and hospitalizations or emergency room visits, and will evaluate the feasibility of health outcome surveillance and the validity of using questionnaires instruments, after routine annual vaccination of the elderly population with Fluarix™.

Recruitment information / eligibility
Status Completed
Enrollment 1524
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria

All subjects must satisfy to the following criteria at study entry:

- (1) A male or female age 65 years at the time of the first vaccination,

- (2) Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., return for follow-up visits, disease reporting by phone, and completion of Questionnaires) should be enrolled in the study

- (3) Written informed consent obtained from the subject

- (4) Availability to follow up by phone during the study period

- (5) Subjects with residence status allowing free mixing with general community.

Exclusion Criteria

The subject must not be included in the study for:

- (1) history of hypersensitivity to a previous dose of influenza vaccine

- (2) history of allergy or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate or sodium deoxycholate,

- (3) use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Biological:
• Fluarix

Locations
Country Name City State
Australia GSK Investigational Site Auchenflower Queensland
Australia GSK Investigational Site Clayton Victoria
Australia GSK Investigational Site Garran Australian Capital Territory
Australia GSK Investigational Site Heidelberg Heights Victoria
Australia GSK Investigational Site Hobart Tasmania
Australia GSK Investigational Site Kippa Ring Queensland
Australia GSK Investigational Site Nedlands Western Australia
Australia GSK Investigational Site Parkville Victoria
Australia GSK Investigational Site South Brisbane Queensland
Australia GSK Investigational Site Umina New South Wales
Brazil GSK Investigational Site Curitiba/Paraná Paraná
Brazil GSK Investigational Site São Paulo

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Australia,  Brazil, 

See also
  Status Clinical Trial Phase
Completed NCT05523089 - The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults Phase 2
Completed NCT05009251 - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake N/A
Completed NCT03282240 - Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US Phase 3
Completed NCT00968539 - Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT00968526 - Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT00971425 - Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1) Phase 3
Completed NCT05525494 - Patient Portal Flu Vaccine Reminders (5) N/A
Completed NCT04074928 - Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects Phase 3
Completed NCT04695717 - This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam Phase 3
Completed NCT05012163 - Lottery Incentive Nudges to Increase Influenza Vaccinations N/A
Completed NCT04109222 - Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively Phase 4
Completed NCT03888989 - Response to Influenza Vaccine During Pregnancy Phase 1
Completed NCT02587221 - Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age Phase 3
Completed NCT03453801 - The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection Phase 1
Completed NCT01440387 - A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older Phase 3
Terminated NCT01195779 - Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children Phase 2
Completed NCT03321968 - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults Phase 3
Completed NCT00972517 - Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children Phase 3
Completed NCT04570904 - Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
Recruiting NCT03331991 - Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel N/A

External Links