Clinical trial NCT01878812: Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine, Fluarix/Influsplit Tetra® (2013/2014 Season), in Adults 18 Years of Age and Older
Official title: Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine (GSK2321138A) Fluarix/Influsplit Tetra® (2013/2014 Season) in Adults 18 Years of Age and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Immunogenicity
Influenza
Adults
Safety
Elderly
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-06-17
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess, in adults 18 years of age and above, the immunogenicity and reactogenicity of the seasonal influenza vaccine, Fluarix/Influsplit Tetra containing the four influenza strains (two A strains and two B strains) for the 2013/2014 season.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol.
* A male or female aged 18 years or above at the time of vaccination.
* Written informed consent obtained from the subject.
* Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering the study.
* Female subjects of non-childbearing potential may be enrolled in the study.

  * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
* 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 on the day of vaccination, and
  * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of vaccination.

Exclusion Criteria:

* Participation in previous year's Fluarix registration study (116663).
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
* Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
* Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
* Administration of an influenza vaccine within the twelve months preceding the study vaccination.
* Receipt of a vaccine other than the study vaccine within 30 days before study vaccination and/or plan to receive any vaccine other than the study vaccine during the entire study period.
* Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
* Acute disease and/or fever at the time of enrollment.

  * Fever is defined as temperature ≥ 37.5°C/99.5°F on oral, axillary or tympanic setting, or ≥ 38.0°C/100.4°F on rectal setting. The preferred route for recording temperature in this study will be axillary.
  * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
* Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insulin-dependent diabetes mellitus), not stabilized or clinically serious.
* History of chronic alcohol consumption and/or drug abuse.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of Guillain-Barré syndrome.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including latex.
* Anaphylaxis following the administration of vaccine(s).
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* Any condition which, in the opinion of the investigator, prevents the subject from participating in the study or would make intramuscular injection unsafe.

Primary outcomes:
measure: Anti-HI Antibody Titers Against 4 Strains of Influenza Disease
timeFrame: At Days 0 and 21
measure: Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
timeFrame: At Day 21
measure: Number of Seroconverted Subjects Against 4 Strains of Influenza Disease
timeFrame: At Day 21
measure: Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease
timeFrame: At Day 21
measure: Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease
timeFrame: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
Secondary outcomes:
measure: Number of Subjects With Solicited Local Symptoms
timeFrame: During a 21-day follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
measure: Number of Days of Solicited Local Symptoms
timeFrame: During the entire study period (Days 0 to 21)
measure: Number of Subjects With Solicited General Symptoms
timeFrame: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
measure: Number of Days of Solicited General Symptoms
timeFrame: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
timeFrame: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
measure: Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs).
timeFrame: At Days 0 and 21
measure: Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status
timeFrame: At Days 0 and 21
measure: Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status
timeFrame: At Day 21
measure: Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status
timeFrame: At Day 21
measure: Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status
timeFrame: At Day 21
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: