A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and Above
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- GlaxoSmithKline
- Enrollment
- 119
- Locations
- 1
- Primary Endpoint
- Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' trivalent influenza vaccine manufactured for the 2012/2013 influenza season administered in adults (18 to 60 years) and in elderly (over 60 years).
Investigators
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.
- •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
- •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
- •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 six months preceding the study vaccination.
- •Planned administration/ administration of a vaccine other than the study vaccine within 30 days before study vaccination and 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 enrolment.
- •Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Chronic underlying disease, not stabilized or clinically serious.
- •History of chronic alcohol consumption and/or drug abuse.
Outcomes
Primary Outcomes
Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains
Time Frame: At Day 0 and Day 21
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/10 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata).
Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
Time Frame: At Day 0 and Day 21
Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40.
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
Time Frame: At Day 21
MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0.
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
Time Frame: At Day 21
A seroconverted subjects was defined as a vaccinee with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value.
Time Frame: At Day 21
SPP was defined as the number of vaccinees with a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40.
Secondary Outcomes
- Duration of Solicited Local Symptoms.(During the 4-day follow-up period (Days 0-3) after vaccination)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.(During the 4-day (Day 0-Day 3) follow-up period after vaccination)
- Duration of Solicited General Symptoms.(During the 4-day follow-up period (Days 0-3) after vaccination)
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)(During the entire study period (Days 0-21))
- Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.(At Day 0 and Day 21)
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).(During the 21-day follow-up period (Days 0-20) after vaccination)
- Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.(At Day 0 and Day 21)
- Number of Subjects Who Seroconverted for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.(At Day 21)
- Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.(At Day 21)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.(During the 4-day follow-up period (Day 0-3) after vaccination)