Study on the Incidence of Influenza and Its Complications, in Subjects Aged 50 Years and Over Vaccinated With Fluarix™

Influenza Clinical Trial

Official title:

A Study to Investigate the Incidence of Influenza and Influenza-related Complications, in Adults Between 50-64 Years and Elderly Adults 65 Years and Over Vaccinated With Fluarix™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00377611
• Other study ID #: 107564
• Status: Completed
• Phase: Phase 4
• Start date: October 5, 2006
• Est. completion date: June 20, 2007

Study information

• Verified date: June 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to investigate the incidence of influenza and influenza-related complications, in adults between 50-64 years and elderly adults 65 years and over vaccinated with Fluarix™

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3054
• Est. completion date: June 20, 2007
• Est. primary completion date: June 20, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• A male or female age 50 years or older at the time of the first vaccination.

• non-childbearing female

• Availability to follow up by phone

• Subjects with residence status allowing free mixing with general community

Exclusion Criteria:

• Use of non-registered products

• Pregnancy

• Hypersensitivity to a previous dose of influenza vaccine

• Acute disease at the time of enrolment/vaccination.

• History of allergy or reactions likely to be exacerbated by any component of the vaccine

• Any contra-indication to intramuscular administration of Fluarix™

• For subjects enrolled in the immunogenicity subset only: administration of immune-modifying drugs within 7 days prior to the vaccination

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Fluarix™

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankfurt/Main	Hessen
Germany	GSK Investigational Site	Gueglingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Leipzg	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Potsdam	Brandenburg
Germany	GSK Investigational Site	Rhaunen	Rheinland-Pfalz
Germany	GSK Investigational Site	Rudersberg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Weinheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Witten	Nordrhein-Westfalen
Netherlands	GSK Investigational Site	Utrecht
Poland	GSK Investigational Site	Debica
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Mielec
Poland	GSK Investigational Site	Porabka
Poland	GSK Investigational Site	Siemianowice Slaskie
Poland	GSK Investigational Site	Wroclaw
United States	GSK Investigational Site	Camillus	New York
United States	GSK Investigational Site	Delray Beach	Florida
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Pembroke Pines	Florida
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Somers Point	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Germany,  Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With at Least One Influenza-like-infection (ILI) Episode	Analysis included all non-confirmed or lab confirmed ILI episodes (at least 1 episode, 1 episode, 2 episodes or more than (>) 2 episodes) reported.	From Month 0 to Month 6
Primary	Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B	Lab confirmed ILI episodes were assessed by means of viral culture (VC) infection (nasal and throat swabs) determination and/or using the Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay.	From Month 0 to Month 6
Primary	Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI	ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance.	From Month 0 to Month 6
Primary	Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza	Laboratory confirmed (LC) ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance.	From Month 0 to Month 6
Primary	Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause	As part of ILI surveillance any reasons, or other reasons than those mentioned which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1).	From Month 0 to Month 6
Primary	Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications	ILI complications which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1) as part of the ILI surveillance, which included: pneumonia, ischemic heart disease, congestive failure, acute cerebrovascular disease chronic obstructive pulmonary disease (COPD) exacerbation.	From Month 0 to Month 6
Primary	Number of Subjects With Influenza-related Complications	ILI complications refer to episodes of pneumonia, ischemic heart disease [HD] (unstable angina or myocardial infarction), congestive heart failure [HF], acute cerebrovascular disease [ACD] (stroke or transient ischemic attack [IA]), COPD exacerbation and all illnesses (pooled episode of each illness). ILI complications were recorded by number of episodes (at least 1 episode, 1 episode and above 1 episode).	From Month 0 to Month 6
Primary	Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection	Death due to lab confirmed influenza infection was recorded during the influeza period only.	From Month 0 to Month 6
Primary	Number of Subjects With Fatal Outcomes	Number of deaths caused by laboratory non-confirmed ILI or other reasons were recorded during the influenza	From Month 0 to Month 6
Primary	Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV)	RSV infection was determined by the RT-PCR assay.	From Month 0 to Month 6
Primary	Number of Subjects With Serious Adverse Events (SAEs)	SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.	From Month 0 to Month 6
Primary	Number of Seroconverted Subjects for Each Influenza Strain	A seroconverted subject was defined as a subject having either a pre-vaccination hemagglutinin inhibition (HI) titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (=) 1:40, or a pre-vaccination titer =1:10 and a minimum four-fold increase in the post-vaccination titer. Assessed influenza strains were A/New Caledonia, A/Wisconsin and B/Malaysia.	At Day 21
Primary	Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease	The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titer (GMT) post vaccination on Day 21 compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.	At Day 21
Primary	Number of Seroprotected Subjects Against the 3 Influenza Strains	A seroprotected subject was defined as a vaccinated subject with a serum HI titer =1:40.	At Day 0 (PRE)
Primary	Number of Seroprotected Subjects Against the 3 Influenza Strains	A seroprotected subject was defined as a vaccinated subject with a serum HI titer =1:40.	At Day 21
Primary	Number of Seropositive Subjects for Each Influenza Strain	A seropositive subject was defined as a vaccinated subject with antibody titer =1:10.	At Day 0 (PRE)
Primary	Number of Seropositive Subjects for Each Influenza Strain	A seropositive subject was defined as a vaccinated subject with an antibody titer =1:10.	At Day 21
Primary	Serum HI Antibody Titers for Each Influenza Strain	Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).	At Day 0 (PRE)
Primary	Serum HI Antibody Titers for Each Influenza Strain	Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).	At Day 21

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