Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years
2018년 5월 9일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
4561
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Huntsville, Alabama, 미국, 35802
- GSK Investigational Site
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Arizona
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Phoenix, Arizona, 미국, 85020
- GSK Investigational Site
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California
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Anaheim, California, 미국, 92801
- GSK Investigational Site
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Florida
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Jacksonville, Florida, 미국, 32216
- GSK Investigational Site
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Melbourne, Florida, 미국, 32935
- GSK Investigational Site
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Miami, Florida, 미국, 33143
- GSK Investigational Site
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Pembroke Pines, Florida, 미국, 33024
- GSK Investigational Site
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Georgia
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Stockbridge, Georgia, 미국, 30281
- GSK Investigational Site
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Illinois
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Chicago, Illinois, 미국, 60610
- GSK Investigational Site
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Peoria, Illinois, 미국, 61602
- GSK Investigational Site
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Indiana
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South Bend, Indiana, 미국, 46601
- GSK Investigational Site
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Kansas
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Lenexa, Kansas, 미국, 66219
- GSK Investigational Site
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Wichita, Kansas, 미국, 67207
- GSK Investigational Site
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Louisiana
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Metairie, Louisiana, 미국, 70006
- GSK Investigational Site
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Maryland
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Rockville, Maryland, 미국, 20850
- GSK Investigational Site
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Missouri
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Saint Louis, Missouri, 미국, 63141
- GSK Investigational Site
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Montana
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Missoula, Montana, 미국, 59801
- GSK Investigational Site
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Nevada
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Las Vegas, Nevada, 미국, 89104
- GSK Investigational Site
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New Jersey
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Edison, New Jersey, 미국, 08817
- GSK Investigational Site
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New York
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Poughkeepsie, New York, 미국, 12601
- GSK Investigational Site
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Rochester, New York, 미국, 14609
- GSK Investigational Site
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North Carolina
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Raleigh, North Carolina, 미국, 27612
- GSK Investigational Site
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Ohio
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Cleveland, Ohio, 미국, 44122
- GSK Investigational Site
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Pennsylvania
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Erie, Pennsylvania, 미국, 16506
- GSK Investigational Site
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Pittsburgh, Pennsylvania, 미국, 15236
- GSK Investigational Site
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South Carolina
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Spartanburg, South Carolina, 미국, 29303
- GSK Investigational Site
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Tennessee
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Nashville, Tennessee, 미국, 37203
- GSK Investigational Site
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Texas
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Austin, Texas, 미국, 78705
- GSK Investigational Site
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Fort Worth, Texas, 미국, 76135
- GSK Investigational Site
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San Angelo, Texas, 미국, 76904
- GSK Investigational Site
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3K 6R8
- GSK Investigational Site
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Truro, Nova Scotia, 캐나다, B2N 1L2
- GSK Investigational Site
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Ontario
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London, Ontario, 캐나다, N5W 6A2
- GSK Investigational Site
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Sarnia, Ontario, 캐나다, N7T 4X3
- GSK Investigational Site
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Sudbury, Ontario, 캐나다, P3E 6C3
- GSK Investigational Site
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Woodstock, Ontario, 캐나다, N4S 4G3
- GSK Investigational Site
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Quebec
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Pointe-Claire, Quebec, 캐나다, H9R 4S3
- GSK Investigational Site
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Quebec City, Quebec, 캐나다, G1E 7G9
- GSK Investigational Site
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Sherbrooke, Quebec, 캐나다, J1H 4J6
- GSK Investigational Site
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St-Romuald, Quebec, 캐나다, G6W 5M6
- GSK Investigational Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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위약 비교기: 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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실험적: 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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위약 비교기: 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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실험적: 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.
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Two intramuscular injections at Days 0 and 21.
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위약 비교기: 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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실험적: 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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위약 비교기: 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.
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Two intramuscular injections at Days 0 and 21.
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실험적: 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.
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Two intramuscular injections at Days 0 and 21.
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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
기간: 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)
기간: 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.
기간: 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.
기간: 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).
기간: 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)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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.
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 1월 23일
기본 완료 (실제)
2008년 10월 15일
연구 완료 (실제)
2009년 3월 19일
연구 등록 날짜
최초 제출
2008년 1월 28일
QC 기준을 충족하는 최초 제출
2008년 2월 5일
처음 게시됨 (추정)
2008년 2월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 6월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 5월 9일
마지막으로 확인됨
2016년 10월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 110464
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
연구 데이터/문서
-
통계 분석 계획
정보 식별자: 110464정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
임상 연구 보고서
정보 식별자: 110464정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
주석이 달린 사례 보고서 양식
정보 식별자: 110464정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
개별 참가자 데이터 세트
정보 식별자: 110464정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
데이터 세트 사양
정보 식별자: 110464정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
정보에 입각한 동의서
정보 식별자: 110464정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
연구 프로토콜
정보 식별자: 110464정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .