Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years
9 mai 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
4561
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- GSK Investigational Site
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Truro, Nova Scotia, Canada, B2N 1L2
- GSK Investigational Site
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Ontario
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London, Ontario, Canada, N5W 6A2
- GSK Investigational Site
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Sarnia, Ontario, Canada, N7T 4X3
- GSK Investigational Site
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Sudbury, Ontario, Canada, P3E 6C3
- GSK Investigational Site
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Woodstock, Ontario, Canada, N4S 4G3
- GSK Investigational Site
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Quebec
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Pointe-Claire, Quebec, Canada, H9R 4S3
- GSK Investigational Site
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Quebec City, Quebec, Canada, G1E 7G9
- GSK Investigational Site
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Sherbrooke, Quebec, Canada, J1H 4J6
- GSK Investigational Site
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St-Romuald, Quebec, Canada, G6W 5M6
- GSK Investigational Site
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Alabama
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Huntsville, Alabama, États-Unis, 35802
- GSK Investigational Site
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Arizona
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Phoenix, Arizona, États-Unis, 85020
- GSK Investigational Site
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California
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Anaheim, California, États-Unis, 92801
- GSK Investigational Site
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Florida
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Jacksonville, Florida, États-Unis, 32216
- GSK Investigational Site
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Melbourne, Florida, États-Unis, 32935
- GSK Investigational Site
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Miami, Florida, États-Unis, 33143
- GSK Investigational Site
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Pembroke Pines, Florida, États-Unis, 33024
- GSK Investigational Site
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Georgia
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Stockbridge, Georgia, États-Unis, 30281
- GSK Investigational Site
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Illinois
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Chicago, Illinois, États-Unis, 60610
- GSK Investigational Site
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Peoria, Illinois, États-Unis, 61602
- GSK Investigational Site
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Indiana
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South Bend, Indiana, États-Unis, 46601
- GSK Investigational Site
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Kansas
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Lenexa, Kansas, États-Unis, 66219
- GSK Investigational Site
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Wichita, Kansas, États-Unis, 67207
- GSK Investigational Site
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Louisiana
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Metairie, Louisiana, États-Unis, 70006
- GSK Investigational Site
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Maryland
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Rockville, Maryland, États-Unis, 20850
- GSK Investigational Site
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Missouri
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Saint Louis, Missouri, États-Unis, 63141
- GSK Investigational Site
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Montana
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Missoula, Montana, États-Unis, 59801
- GSK Investigational Site
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Nevada
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Las Vegas, Nevada, États-Unis, 89104
- GSK Investigational Site
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New Jersey
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Edison, New Jersey, États-Unis, 08817
- GSK Investigational Site
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New York
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Poughkeepsie, New York, États-Unis, 12601
- GSK Investigational Site
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Rochester, New York, États-Unis, 14609
- GSK Investigational Site
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North Carolina
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Raleigh, North Carolina, États-Unis, 27612
- GSK Investigational Site
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Ohio
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Cleveland, Ohio, États-Unis, 44122
- GSK Investigational Site
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Pennsylvania
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Erie, Pennsylvania, États-Unis, 16506
- GSK Investigational Site
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Pittsburgh, Pennsylvania, États-Unis, 15236
- GSK Investigational Site
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South Carolina
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Spartanburg, South Carolina, États-Unis, 29303
- GSK Investigational Site
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Tennessee
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Nashville, Tennessee, États-Unis, 37203
- GSK Investigational Site
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Texas
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Austin, Texas, États-Unis, 78705
- GSK Investigational Site
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Fort Worth, Texas, États-Unis, 76135
- GSK Investigational Site
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San Angelo, Texas, États-Unis, 76904
- GSK Investigational Site
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Comparateur placebo: 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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Expérimental: 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.
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Two intramuscular injections at Days 0 and 21.
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Comparateur placebo: 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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Expérimental: 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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Comparateur placebo: 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.
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Two intramuscular injections at Days 0 and 21.
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Expérimental: 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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Comparateur placebo: 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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Expérimental: 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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Comparateur placebo: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
Délai: 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)
Délai: 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.
Délai: 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.
Délai: 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).
Délai: 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)
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10
Délai: 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
Délai: 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)
Délai: At Month 6 (Day 182) after Dose 1
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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 Month 6 (Day 182) after Dose 1
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Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
Délai: 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)
Délai: 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.
Délai: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
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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.
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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
Délai: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
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Titers were expressed as Geometric Mean Titers (GMTs).
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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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
23 janvier 2008
Achèvement primaire (Réel)
15 octobre 2008
Achèvement de l'étude (Réel)
19 mars 2009
Dates d'inscription aux études
Première soumission
28 janvier 2008
Première soumission répondant aux critères de contrôle qualité
5 février 2008
Première publication (Estimation)
15 février 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 juin 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 mai 2018
Dernière vérification
1 octobre 2016
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 110464
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Données/documents d'étude
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Plan d'analyse statistique
Identifiant des informations: 110464Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Rapport d'étude clinique
Identifiant des informations: 110464Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Formulaire de rapport de cas annoté
Identifiant des informations: 110464Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Ensemble de données de participant individuel
Identifiant des informations: 110464Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Spécification du jeu de données
Identifiant des informations: 110464Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Formulaire de consentement éclairé
Identifiant des informations: 110464Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Protocole d'étude
Identifiant des informations: 110464Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .