Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years
9. května 2018 aktualizováno: GlaxoSmithKline
A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccination Regimen in Adults Aged ≥18 Years
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.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Intervenční
Zápis (Aktuální)
4561
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3K 6R8
- GSK Investigational Site
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Truro, Nova Scotia, Kanada, B2N 1L2
- GSK Investigational Site
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Ontario
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London, Ontario, Kanada, N5W 6A2
- GSK Investigational Site
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Sarnia, Ontario, Kanada, N7T 4X3
- GSK Investigational Site
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Sudbury, Ontario, Kanada, P3E 6C3
- GSK Investigational Site
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Woodstock, Ontario, Kanada, N4S 4G3
- GSK Investigational Site
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Quebec
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Pointe-Claire, Quebec, Kanada, H9R 4S3
- GSK Investigational Site
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Quebec City, Quebec, Kanada, G1E 7G9
- GSK Investigational Site
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Sherbrooke, Quebec, Kanada, J1H 4J6
- GSK Investigational Site
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St-Romuald, Quebec, Kanada, G6W 5M6
- GSK Investigational Site
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Alabama
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Huntsville, Alabama, Spojené státy, 35802
- GSK Investigational Site
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Arizona
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Phoenix, Arizona, Spojené státy, 85020
- GSK Investigational Site
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California
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Anaheim, California, Spojené státy, 92801
- GSK Investigational Site
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Florida
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Jacksonville, Florida, Spojené státy, 32216
- GSK Investigational Site
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Melbourne, Florida, Spojené státy, 32935
- GSK Investigational Site
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Miami, Florida, Spojené státy, 33143
- GSK Investigational Site
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Pembroke Pines, Florida, Spojené státy, 33024
- GSK Investigational Site
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Georgia
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Stockbridge, Georgia, Spojené státy, 30281
- GSK Investigational Site
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Illinois
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Chicago, Illinois, Spojené státy, 60610
- GSK Investigational Site
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Peoria, Illinois, Spojené státy, 61602
- GSK Investigational Site
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Indiana
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South Bend, Indiana, Spojené státy, 46601
- GSK Investigational Site
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Kansas
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Lenexa, Kansas, Spojené státy, 66219
- GSK Investigational Site
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Wichita, Kansas, Spojené státy, 67207
- GSK Investigational Site
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Louisiana
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Metairie, Louisiana, Spojené státy, 70006
- GSK Investigational Site
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Maryland
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Rockville, Maryland, Spojené státy, 20850
- GSK Investigational Site
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Missouri
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Saint Louis, Missouri, Spojené státy, 63141
- GSK Investigational Site
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Montana
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Missoula, Montana, Spojené státy, 59801
- GSK Investigational Site
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Nevada
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Las Vegas, Nevada, Spojené státy, 89104
- GSK Investigational Site
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New Jersey
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Edison, New Jersey, Spojené státy, 08817
- GSK Investigational Site
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New York
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Poughkeepsie, New York, Spojené státy, 12601
- GSK Investigational Site
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Rochester, New York, Spojené státy, 14609
- GSK Investigational Site
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North Carolina
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Raleigh, North Carolina, Spojené státy, 27612
- GSK Investigational Site
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Ohio
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Cleveland, Ohio, Spojené státy, 44122
- GSK Investigational Site
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Pennsylvania
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Erie, Pennsylvania, Spojené státy, 16506
- GSK Investigational Site
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Pittsburgh, Pennsylvania, Spojené státy, 15236
- GSK Investigational Site
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South Carolina
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Spartanburg, South Carolina, Spojené státy, 29303
- GSK Investigational Site
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Tennessee
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Nashville, Tennessee, Spojené státy, 37203
- GSK Investigational Site
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Texas
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Austin, Texas, Spojené státy, 78705
- GSK Investigational Site
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Fort Worth, Texas, Spojené státy, 76135
- GSK Investigational Site
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San Angelo, Texas, Spojené státy, 76904
- GSK Investigational Site
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
- Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to either vaccination.
- Lactating or nursing.
- Women of child bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments.
- Known use of an analgesic or antipyretic medication within 12 hours prior to first treatment.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Influenza A (H5N1) 18-64Y Group
Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
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Two intramuscular injections at Days 0 and 21.
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Komparátor placeba: Placebo 18-64Y Group
Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
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Two intramuscular injections at Days 0 and 21.
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Experimentální: Influenza A (H5N1) >64Y Group
Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
|
Two intramuscular injections at Days 0 and 21.
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Komparátor placeba: Placebo >64Y Group
Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
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Two intramuscular injections at Days 0 and 21.
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Experimentální: Influenza A (H5N1) Group
Pooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
|
Two intramuscular injections at Days 0 and 21.
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Komparátor placeba: Placebo Group
Pooled group of subjects aged >18 years, who received 2 doses of placebo at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
|
Two intramuscular injections at Days 0 and 21.
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Experimentální: Influenza A (H5N1) 18-60Y Group
Subjects aged 18-60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
|
Two intramuscular injections at Days 0 and 21.
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Komparátor placeba: Placebo 18-60Y Group
Subjects aged 18-60 years, who received 2 doses of placebo at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
|
Two intramuscular injections at Days 0 and 21.
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Experimentální: Influenza A (H5N1) >60Y Group
Subjects aged >60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
|
Two intramuscular injections at Days 0 and 21.
|
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Komparátor placeba: Placebo >60Y Group
Subjects aged > 60 years, who received 2 doses of placebo at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
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Two intramuscular injections at Days 0 and 21.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
Časové okno: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
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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.
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At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
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Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
Časové okno: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
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A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
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At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
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Number of Subjects With Any Solicited Local Symptoms.
Časové okno: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
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Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
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During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
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Number of Subjects With Any Solicited General Symptoms.
Časové okno: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
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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.
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During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
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Number of Subjects With Any Unsolicited Adverse Events (AEs).
Časové okno: During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)
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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.
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During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)
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Number of Subjects With Serious Adverse Events (SAEs)
Časové okno: From Day 0 through Day 182 and through Day 379.
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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.
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From Day 0 through Day 182 and through Day 379.
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Number of Subjects With Medically Attended Events (MAEs)
Časové okno: From Day 0 through Day 182 and through Day 364.
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From Day 0 through Day 182 and through Day 364.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10
Časové okno: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
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At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
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Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10
Časové okno: At Month 6 (Day 182) post Dose 1
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At Month 6 (Day 182) post Dose 1
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Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
Časové okno: At Month 6 (Day 182) after Dose 1
|
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.
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At Month 6 (Day 182) after Dose 1
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Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
Časové okno: At Month 6 (Day 182) after Dose 1
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At Month 6 (Day 182) after Dose 1
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Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1)
Časové okno: At Month 6 (Day 182) after Dose 1
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Titers are presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was ≥ 1:10.
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At Month 6 (Day 182) after Dose 1
|
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Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays.
Časové okno: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
|
Virus antibody response rates were defined as the number of subjects with antibody titers at Day 42 ≥ 4-fold the pre-vaccination antibody titers.
The 2 strains assessed were Flu A/Indonesia/5/05 and Flu A/Vietnam/1194/04.
|
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
Časové okno: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
|
Titers were expressed as Geometric Mean Titers (GMTs).
|
At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
23. ledna 2008
Primární dokončení (Aktuální)
15. října 2008
Dokončení studie (Aktuální)
19. března 2009
Termíny zápisu do studia
První předloženo
28. ledna 2008
První předloženo, které splnilo kritéria kontroly kvality
5. února 2008
První zveřejněno (Odhad)
15. února 2008
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
8. června 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. května 2018
Naposledy ověřeno
1. října 2016
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 110464
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studijní data/dokumenty
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Plán statistické analýzy
Identifikátor informace: 110464Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Zpráva o klinické studii
Identifikátor informace: 110464Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Formulář komentované zprávy o případu
Identifikátor informace: 110464Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Soubor dat jednotlivých účastníků
Identifikátor informace: 110464Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Specifikace datové sady
Identifikátor informace: 110464Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Formulář informovaného souhlasu
Identifikátor informace: 110464Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Protokol studie
Identifikátor informace: 110464Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .