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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- GlaxoSmithKline
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 Southern hemisphere) in adults (18 to 60 years of age) and in the elderly (over 60 years of age).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject prior to performing any study specific procedure.
- •A male or female aged 18 years or above at the time of vaccination.
- •Healthy subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering into the study.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •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 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 (Day -29 to Day 0), 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 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
- •Administration of long-acting immune-modifying drugs (e.g. rituximab, infliximab, etc.) within 6 months before study start, or planned administration during the study.
- •Planned administration/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 during the period starting 3 months before 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 vaccine/product (pharmaceutical product or device).
- •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 (no laboratory testing required).
Outcomes
Primary Outcomes
Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.
Time Frame: At Days 0 and 21.
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.
Time Frame: At Day 21
MGI also known as the seroconversion factor \[SCF\] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.
Time Frame: At Day 21
SPP was defined as the number of vaccinated subjects with a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
Time Frame: At Days 0 and 21
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cutoff value of 1:10. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Time Frame: At Days 0 and 21
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.
Time Frame: At Day 21.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination HI titer less than (\<) 1:10 and a post-vaccination HI titer ≥1:40 or pre-vaccination HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination HI titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Secondary Outcomes
- MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.(At Day 21)
- Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.(At Day 21)
- Duration of Solicited General Symptoms(During the 4-day (Days 0-3) post-vaccination period)
- Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies.(At Days 0 and 21)
- Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.(At Days 0 and 21)
- Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.(At Days 0 and 21)
- Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.(At Day 21.)
- Duration of Solicited Local Symptoms(During the 4-day (Days 0-3) post-vaccination period)
- Number of Subjects Reporting Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).(During the entire study period (approximately 21 days for each subject).)
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)(During the entire study period (approximately 21 days for each subject))
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.(During the 4-day (Days 0-3) post-vaccination period)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.(During the 4-day (Days 0-3) post-vaccination period)
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During the 21-day (Days 0-20) post-vaccination period.)