Phase 4 N=3,054 Prevention

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

Influenza

Bottom Line

View on ClinicalTrials.gov: NCT00377611 ↗

Enrolled (actual)

3,054

Serious AEs

4.2%

Results posted

Oct 2018

Primary outcome: Primary: Number of Subjects With at Least One Influenza-like-infection (ILI) Episode — 133; 243; 376; 125 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Fluarix™ (Biological)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Jun 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With at Least One Influenza-like-infection (ILI) Episode	133; 243; 376; 125; 231; 356	—
PRIMARY Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B	13; 15; 28; 13; 15; 28	—
PRIMARY Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI	31; 51; 82; 31; 49; 80	—
PRIMARY Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza	2; 6; 8; 2; 6; 8	—
PRIMARY Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause	47; 124; 171; 43; 107; 150	—
PRIMARY Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications	4; 16; 20; 4; 14; 18	—
PRIMARY Number of Subjects With Influenza-related Complications	2; 9; 11; 2; 9; 11	—
PRIMARY Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection	0; 0; 0	—
PRIMARY Number of Subjects With Fatal Outcomes	0; 0; 0; 1; 6; 7	—
PRIMARY Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV)	16; 27; 43	—
PRIMARY Number of Subjects With Serious Adverse Events (SAEs)	23; 105; 128	—
PRIMARY Number of Seroconverted Subjects for Each Influenza Strain	171; 306; 477; 167; 304; 471	—
PRIMARY Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease	216.4; 142.9; 165.8; 156.7; 179.1; 170.8	—
PRIMARY Number of Seroprotected Subjects Against the 3 Influenza Strains	161; 294; 455; 144; 280; 424	—
PRIMARY Number of Seroprotected Subjects Against the 3 Influenza Strains	161; 294; 455; 144; 280; 424	—
PRIMARY Number of Seropositive Subjects for Each Influenza Strain	171; 306; 477; 167; 304; 471	—
PRIMARY Number of Seropositive Subjects for Each Influenza Strain	171; 306; 477; 167; 304; 471	—
PRIMARY Serum HI Antibody Titers for Each Influenza Strain	216.4; 142.9; 165.8; 156.7; 179.1; 170.8	—
PRIMARY Serum HI Antibody Titers for Each Influenza Strain	216.4; 142.9; 165.8; 156.7; 179.1; 170.8	—

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™

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00377611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.