A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccination Regimen in Adults Aged ≥18 Years
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- GlaxoSmithKline
- Enrollment
- 4561
- Locations
- 1
- Primary Endpoint
- Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to characterize the immunogenicity & safety of the investigation vaccination regimen of GSK 1557484A vaccine given to adults aged ≥18 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A male or female 18 years of age or greater at the time of the first vaccination.
- •Written informed consent obtained from the subject.
- •Among 18 to 49 year old subjects, good general health as established by medical history and clinical examination before entering into the study.
- •Among subjects \> 49 years of age, stable health status within 1 month prior to enrollment.
- •Access to a consistent means of telephone contact.
- •Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
Exclusion Criteria
- •Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subjectunable/unlikely to provide accurate safety reports.
- •Diagnosed with cancer, or treatment for cancer, within 3 years.
- •An oral temperature ≥37.8º C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus infection.
- •Receipt of systemic glucocorticoids within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
- •Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
- •Administration of any vaccines within 30 days before study enrollment.
- •Previous administration of any H5N1 vaccine.
- •Use of any investigational or non-registered product or planned participation in another investigational study within 30 days prior to study enrollment, or during the 364 days following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.
- •Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
Outcomes
Primary Outcomes
Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
Time Frame: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer \< 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
Time Frame: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Number of Subjects With Any Solicited Local Symptoms.
Time Frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Solicited General Symptoms.
Time Frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Assessed solicited general symptoms were fatigue, headache, joint pain at other locations, muscle aches, shivering, sweating and temperature\[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Time Frame: During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
Time Frame: From Day 0 through Day 182 and through Day 379.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With Medically Attended Events (MAEs)
Time Frame: From Day 0 through Day 182 and through Day 364.
Secondary Outcomes
- Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)(At Month 6 (Day 182) after Dose 1)
- Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays.(At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2))
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays(At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2))
- Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10(At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2))
- Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10(At Month 6 (Day 182) post Dose 1)
- Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)(At Month 6 (Day 182) after Dose 1)
- Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1)(At Month 6 (Day 182) after Dose 1)