A phase III study for the evaluation of the immunogenicity and reactogenicity of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 season Southern Hemisphere) in adults 18 years of age and above

Phase 3

• Conditions: Flu; C02.782.620.365

• Registration Number: RBR-4bfx9c
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-06
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Male and female subjects aged 18 years or above at the time of vaccination; healthy with well-controlled chronic diseases; will comply with the requirements of the protocol and give written informed consent. Female subjects of non-childbearing potential. Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test at screening and on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series

Exclusion Criteria

Use of any investigational or non-registered product, drug or vaccine, other than the study vaccine during the period starting 30 days before the dose of study vaccine or planned use during the study period; any medical condition that in the judgment of the investigator would make intramuscular injection unsafe; chronic administration, defined as more than 14 consecutive days, of immunosuppressants or other immune-modifying drugs within six months before study start or planned administration during the study; planned administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the study vaccination and during the entire study period; administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period; administration of an influenza vaccine within the 6 months preceding the study start or planned use of such vaccines during the study period; concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product; clinically or virologically confirmed influenza infection within the six months preceding the study vaccination; any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination; acute disease and/or fever at the time of enrollment; acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory testing performed at the screening visit; chronic underlying disease not stabilised or clinically serious;history of chronic alcohol consumption and/or drug abuse; history of Guillain-Barré syndrome; history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, including latex; history of severe adverse reaction to a previous influenza vaccination; anaphylaxis following the administration of vaccine(s); pregnant or breastfeeding female; subject planning to become pregnant or planning to discontinue contraceptive precautions during the study period.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Humoral immune response for each vaccine strain (1) in terms of antibodies in adults 18-60 years and in elderly above 60 years (2). The following aggregate variables will be calculated with confidence interval of 95% (3): Geometric mean titre for antibodies at Days 0 and 21; Seropositivity rate at Days 0 and 21; Seroprotection rate at Days 0 and 21; Seroconversion rate at Day 21; Seroprotection power at Day 21; Mean geometric increase also known as the<br>seroconversion factor at Day 21.