Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-03 @ 12:31 AM
Study NCT ID:
NCT02177734
Status:
WITHDRAWN
Last Update Posted:
2016-06-20
First Post:
2014-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine(s) GSK3277510A and GSK3277509A in Adults 18 to 60 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study was cancelled for scientifically legitimate reasons not related to safety or efficacy of the vaccine.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-16', 'studyFirstSubmitDate': '2014-06-19', 'studyFirstSubmitQcDate': '2014-06-26', 'lastUpdatePostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers', 'timeFrame': 'At Day 42.'}, {'measure': 'Occurrence of each solicited local symptom', 'timeFrame': 'During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination.'}, {'measure': 'Occurrence of each solicited general symptom', 'timeFrame': 'During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination.'}, {'measure': 'Occurrence of clinical safety laboratory abnormalities reported for samples', 'timeFrame': 'At the Day 0, 7, 21, 28 and 42 visits.'}, {'measure': 'Occurrence of unsolicited adverse events (AEs)', 'timeFrame': '21 days after each dose.'}, {'measure': 'Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs)[Active Phase]', 'timeFrame': 'From Day 0 until Day 42.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of adjuvant effect as assessed by vaccine-homologous hemagglutination inhibition (HI) antibody titers', 'timeFrame': 'At Day 42.'}, {'measure': 'Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers for plain antigen vaccine group', 'timeFrame': 'At Day 42.'}, {'measure': 'Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers.', 'timeFrame': 'GMTs and Seropositivity rates at Days 0, 21, 42 and Months 6 and 12. SCR and MGI at Days 21, 42 (Placebo group only) and Months 6 and 12. SPR at Days 0, 21, 42 (Placebo group only) and Months 6 and 12.'}, {'measure': 'Humoral immune response in terms of vaccine-homologous (H7N9) neutralizing (MN) antibody titres.', 'timeFrame': 'GMTs and Seropositivity rates at the Days 0, 21, 42 and Month 6 visits. VRR at Days 21, 42 and Month 6 visits.'}, {'measure': 'Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers by age stratum.', 'timeFrame': 'GMTs, Seropositivity rates and SPR at Days 0, 21, 42 and Months 6 and 12. SCR and MGI at Days 21, 42 and Months 6 and 12.'}, {'measure': 'Humoral immune response in terms of vaccine homologous (H7N9) neutralizing (MN) antibody titers for each study group by age stratum (18-40 years; 41-60 years)', 'timeFrame': 'GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6. VRR at Days 21, 42 and Month 6.'}, {'measure': 'Occurrence of MAEs, pIMDs and SAEs', 'timeFrame': 'Until the Month 12 visit.'}]}, 'conditionsModule': {'keywords': ['Adjuvant', 'Safety', 'Influenza', 'H7N9', 'Immunogenicity', 'Adults'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 60 years of age."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female adults who are 18 to 60years of age (inclusive) at the time of first study vaccination.\n* Written informed consent obtained from subject.\n* Subjects who the investigator believes can and will comply with the requirements of the protocol.\n* Healthy subjects as established by medical history and physical examination.\n* Access to a consistent means of telephone contact.\n* For subjects who undergo a screening visit: Results of screening safety laboratory tests that figure in eligibility assessment must be within reference ranges before dosing.\n* Female subjects of non-childbearing potential may be enrolled in the study.\n* Female subjects of childbearing potential may be enrolled in the study, if they\n\n * have practiced adequate contraception for 30 days prior to vaccination, and\n * have a negative pregnancy test on the day of vaccination, and agree to continue to practice adequate contraception until 2 months after the last dose administered.\n\nExclusion Criteria:\n\n* Presence or evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.\n* Presence or evidence of substance abuse.\n* Diagnosed with cancer, or treatment for cancer within three years.\n* Diagnosed with excessive daytime sleepiness, or narcolepsy; or history of narcolepsy in a subject\'s parent, sibling or child.\n* Presence of a temperature ≥ 38.0ºC (≥100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.\n* Receipt of systemic glucocorticoids within 30 days prior to the first dose of study vaccine/placebo, or any other cytotoxic, immunosuppressive or immune-modifying drugs within 6 months of first study vaccine/ placebo dose.\n* Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.\n* An acute evolving neurological disorder or Guillain Barré Syndrome within 42 days of receipt of prior seasonal or pandemic influenza vaccine.\n* Administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before the first dose of study vaccine/placebo.\n* Planned administration of any vaccine other than the study vaccine/placebo before blood sampling at the Day 42 visit.\n* Previous administration of any H7 vaccine or physician-confirmed H7 disease.\n* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period.\n* Receipt of any immunoglobulins and/or any blood products within 90 days before the first dose of study vaccine/placebo, or planned administration of any of these products during the study period.\n* Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine including a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.\n* Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result before the first dose of study vaccine/placebo.\n* Lactating or nursing women.\n* Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.'}, 'identificationModule': {'nctId': 'NCT02177734', 'briefTitle': "Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine(s) GSK3277510A and GSK3277509A in Adults 18 to 60 Years of Age", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine(s) GSK3277510A and GSK3277509A Administered in Adults 18 to 60 Years of Age", 'orgStudyIdInfo': {'id': '201300'}, 'secondaryIdInfos': [{'id': '2014-000796-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Formulation 1 Group', 'description': 'Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 1 at a 21 day interval', 'interventionNames': ['Biological: Investigational H7N9 vaccine GSK3277510A']}, {'type': 'EXPERIMENTAL', 'label': 'Formulation 2 Group', 'description': 'Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 2 at a 21 day interval', 'interventionNames': ['Biological: Investigational H7N9 vaccine GSK3277510A']}, {'type': 'EXPERIMENTAL', 'label': 'Formulation 3 Group', 'description': 'Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 3 at a 21 day interval', 'interventionNames': ['Biological: Investigational H7N9 vaccine GSK3277510A']}, {'type': 'EXPERIMENTAL', 'label': 'Formulation 4 Group', 'description': 'Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 4 at a 21 day interval', 'interventionNames': ['Biological: Investigational H7N9 vaccine GSK3277510A']}, {'type': 'EXPERIMENTAL', 'label': 'Formulation 5 Group', 'description': 'Subjects in this group will receive two doses of GSK3277509A H7N9 vaccine formulation 5 at a 21 day interval', 'interventionNames': ['Biological: Investigational H7N9 vaccine GSK3277509A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Subjects in this group will receive two doses of placebo at a 21 day interval', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Investigational H7N9 vaccine GSK3277510A', 'type': 'BIOLOGICAL', 'description': 'One dose of GSK3277510A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277510A H7N9 vaccine administered IM in the deltoid region of dominant arm at Day 21', 'armGroupLabels': ['Formulation 1 Group', 'Formulation 2 Group', 'Formulation 3 Group', 'Formulation 4 Group']}, {'name': 'Investigational H7N9 vaccine GSK3277509A', 'type': 'BIOLOGICAL', 'description': 'One dose of GSK3277509A H7N9 vaccine administered IM at the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277509A H7N9 vaccine administered IM at the deltoid region of dominant arm at Day 21', 'armGroupLabels': ['Formulation 5 Group']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'One dose of placebo administered IM at the deltoid region of non-dominant arm at Day 0 and the second dose of placebo administered IM at the deltoid region of dominant arm at Day 21', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}