Immunogenicity and Safety of GSK Biologicals' Pandemic Influenza Candidate Vaccine GSK2340272A
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- GlaxoSmithKline
- Enrollment
- 145
- Locations
- 1
- Primary Endpoint
- Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects 61 years of age or older at the time of the first vaccination.
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject.
- •Satisfactory baseline medical assessment by history and physical examination (stable health status with no exclusionary medical or psychiatric conditions). Stable health status is defined as the absence of health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrolment.
Exclusion Criteria
- •Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern Hemisphere influenza vaccine.
- •Previous administration of a pandemic influenza vaccine.
- •Administration of any vaccine within 30 days before first vaccination.
- •Planned administration of a vaccine not foreseen by the study protocol one month (minimum 30 days) after the second vaccination with the GSK2340272A candidate vaccine.
- •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccines or planned use during the study period. Potential subjects in the follow-up phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
- •Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- •Presence of an axillary temperature \>= 37.5°C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
- •Diagnosed with cancer, or treatment for cancer, within 3 years.
- •Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
- •Persons with a history of histological-confirmed basal cell carcinoma of the skin successfully treated with local excisions only are eligible and may be enrolled within 3 years of diagnosis, but other histological types of skin cancer require a 3-year untreated and disease-free window as above.
Outcomes
Primary Outcomes
Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain
Time Frame: At Day 42
The Pandemrix vaccine strain was A/Cal/7/09. A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain
Time Frame: At Day 42
The Pandemrix vaccine strain was A/Cal/7/09. The cut-off was a titer of 1:10 and this titer was considered as seropositivity.
Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain
Time Frame: At Day 42
Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination compared to prevaccination (Day 0). The Pandemrix vaccine strain was A/Cal/7/09.
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain
Time Frame: At Day 42
The Pandemrix vaccine strain was A/Cal/7/09. A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40.
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain
Time Frame: At Day 42
Titers were expressed as GMTs. The Pandemrix vaccine strain was A/Cal/7/09.
Secondary Outcomes
- Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains(At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.)
- Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains(At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.)
- Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains(Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12)
- Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains(Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12)
- Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains(At Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During 21 days (Day 0-20) after each vaccination)
- Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix(During a 7-Day (Day 0-6) follow-up period after each administration of Pandemrix)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (Day 0-364))
- Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix(During a 7-Day (Day 0-6) follow-up period after each administration of (at Day -21 and at Day 42) placebo or Fluarix)
- Number of Subjects With AEs of Specific Interest(During the entire study period (Day 0-364))