Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years
keskiviikko 9. toukokuuta 2018 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
4561
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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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, Yhdysvallat, 35802
- GSK Investigational Site
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Arizona
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Phoenix, Arizona, Yhdysvallat, 85020
- GSK Investigational Site
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California
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Anaheim, California, Yhdysvallat, 92801
- GSK Investigational Site
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Florida
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Jacksonville, Florida, Yhdysvallat, 32216
- GSK Investigational Site
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Melbourne, Florida, Yhdysvallat, 32935
- GSK Investigational Site
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Miami, Florida, Yhdysvallat, 33143
- GSK Investigational Site
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Pembroke Pines, Florida, Yhdysvallat, 33024
- GSK Investigational Site
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Georgia
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Stockbridge, Georgia, Yhdysvallat, 30281
- GSK Investigational Site
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Illinois
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Chicago, Illinois, Yhdysvallat, 60610
- GSK Investigational Site
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Peoria, Illinois, Yhdysvallat, 61602
- GSK Investigational Site
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Indiana
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South Bend, Indiana, Yhdysvallat, 46601
- GSK Investigational Site
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Kansas
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Lenexa, Kansas, Yhdysvallat, 66219
- GSK Investigational Site
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Wichita, Kansas, Yhdysvallat, 67207
- GSK Investigational Site
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Louisiana
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Metairie, Louisiana, Yhdysvallat, 70006
- GSK Investigational Site
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Maryland
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Rockville, Maryland, Yhdysvallat, 20850
- GSK Investigational Site
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Missouri
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Saint Louis, Missouri, Yhdysvallat, 63141
- GSK Investigational Site
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Montana
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Missoula, Montana, Yhdysvallat, 59801
- GSK Investigational Site
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Nevada
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Las Vegas, Nevada, Yhdysvallat, 89104
- GSK Investigational Site
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New Jersey
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Edison, New Jersey, Yhdysvallat, 08817
- GSK Investigational Site
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New York
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Poughkeepsie, New York, Yhdysvallat, 12601
- GSK Investigational Site
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Rochester, New York, Yhdysvallat, 14609
- GSK Investigational Site
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North Carolina
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Raleigh, North Carolina, Yhdysvallat, 27612
- GSK Investigational Site
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Ohio
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Cleveland, Ohio, Yhdysvallat, 44122
- GSK Investigational Site
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Pennsylvania
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Erie, Pennsylvania, Yhdysvallat, 16506
- GSK Investigational Site
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Pittsburgh, Pennsylvania, Yhdysvallat, 15236
- GSK Investigational Site
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South Carolina
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Spartanburg, South Carolina, Yhdysvallat, 29303
- GSK Investigational Site
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Tennessee
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Nashville, Tennessee, Yhdysvallat, 37203
- GSK Investigational Site
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Texas
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Austin, Texas, Yhdysvallat, 78705
- GSK Investigational Site
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Fort Worth, Texas, Yhdysvallat, 76135
- GSK Investigational Site
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San Angelo, Texas, Yhdysvallat, 76904
- GSK Investigational Site
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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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Placebo Comparator: 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.
|
Two intramuscular injections at Days 0 and 21.
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Kokeellinen: 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.
|
|
Placebo Comparator: 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.
|
Two intramuscular injections at Days 0 and 21.
|
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Kokeellinen: 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.
|
|
Placebo Comparator: 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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Kokeellinen: 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.
|
|
Placebo Comparator: 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.
|
|
Kokeellinen: 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.
|
|
Placebo Comparator: 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.
|
Two intramuscular injections at Days 0 and 21.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
Aikaikkuna: 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)
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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).
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: At Month 6 (Day 182) after Dose 1
|
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.
Aikaikkuna: 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)
|
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays
Aikaikkuna: 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)
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Keskiviikko 23. tammikuuta 2008
Ensisijainen valmistuminen (Todellinen)
Keskiviikko 15. lokakuuta 2008
Opintojen valmistuminen (Todellinen)
Torstai 19. maaliskuuta 2009
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 28. tammikuuta 2008
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 5. helmikuuta 2008
Ensimmäinen Lähetetty (Arvio)
Perjantai 15. helmikuuta 2008
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Perjantai 8. kesäkuuta 2018
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 9. toukokuuta 2018
Viimeksi vahvistettu
Lauantai 1. lokakuuta 2016
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 110464
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Tutkimustiedot/asiakirjat
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Tilastollinen analyysisuunnitelma
Tiedon tunniste: 110464Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Kliinisen tutkimuksen raportti
Tiedon tunniste: 110464Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Selosteilla varustettu tapausraporttilomake
Tiedon tunniste: 110464Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Yksittäisen osallistujan tietojoukko
Tiedon tunniste: 110464Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
-
Tietojoukon määritys
Tiedon tunniste: 110464Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
-
Ilmoitettu suostumuslomake
Tiedon tunniste: 110464Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Tutkimuspöytäkirja
Tiedon tunniste: 110464Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
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National Institute of Allergy and Infectious Diseases...Valmis
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Cyclacel Pharmaceuticals, Inc.LopetettuEi-pienisoluinen keuhkosyöpäYhdysvallat