Nctid:
NCT06614725
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000018357", "term"=>"Respiratory Syncytial Virus Infections"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}], "ancestors"=>[{"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000018186", "term"=>"Pneumovirus Infections"}, {"id"=>"D000018184", "term"=>"Paramyxoviridae Infections"}, {"id"=>"D000018701", "term"=>"Mononegavirales Infections"}, {"id"=>"D000012327", "term"=>"RNA Virus Infections"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M20494", "name"=>"Respiratory Syncytial Virus Infections", "asFound"=>"Respiratory Syncytial Virus Infections", "relevance"=>"HIGH"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "asFound"=>"Respiratory Tract Diseases", "relevance"=>"HIGH"}, {"id"=>"M20330", "name"=>"Paramyxoviridae Infections", "relevance"=>"LOW"}, {"id"=>"M20778", "name"=>"Mononegavirales Infections", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M21860", "name"=>"Pharmaceutical Solutions", "relevance"=>"LOW"}, {"id"=>"M17360", "name"=>"Vaccines", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Pharmaceutical Solutions", "abbrev"=>"PhSol"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"Click here to enter text."}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>750}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-10-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-10", "completionDateStruct"=>{"date"=>"2025-10-28", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-10-03", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-05-13", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"RSV-A neutralizing titers", "timeFrame"=>"At baseline (Day 1), pre-study intervention administration"}, {"measure"=>"RSV-A neutralizing titers", "timeFrame"=>"At 1 month (Day 31) post-study intervention administration"}, {"measure"=>"RSV-B neutralizing titers", "timeFrame"=>"At baseline (Day 1), pre-study intervention administration"}, {"measure"=>"RSV-B neutralizing titers", "timeFrame"=>"At 1 month (Day 31) post-study intervention administration"}], "secondaryOutcomes"=>[{"measure"=>"Percentage of participants reporting each solicited administration site event", "timeFrame"=>"Within 4 days post-study intervention administration (i.e. the day of study intervention administration [Day 1] and 3 subsequent days)", "description"=>"The assessed solicited administration site events are pain, erythema (redness) and swelling at administration site."}, {"measure"=>"Percentage of participants reporting each solicited systematic event", "timeFrame"=>"Within 4 days post-study intervention administration (i.e. the day of study intervention administration [Day 1] and 3 subsequent days)", "description"=>"The assessed solicited systemic events are fever, headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness). Fever is defined as temperature \\>= 38.0 degrees Celsius (°C) /100.4 degrees Fahrenheit (°F), regardless of the location of . measurement."}, {"measure"=>"Percentage of participants reporting unsolicited adverse events (AEs)", "timeFrame"=>"Within 30 days post-study intervention administration (i.e. the day of study intervention administration [Day 1] and 29 subsequent days)", "description"=>"An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs."}, {"measure"=>"Percentage of participants reporting serious adverse events (SAEs)", "timeFrame"=>"From study intervention administration (Day 1) up to study end (Month 6 after study intervention administration)", "description"=>"An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes."}, {"measure"=>"Percentage of participants reporting potential immune-mediated diseases (pIMDs)", "timeFrame"=>"From study intervention administration (Day 1) up to study end (Month 6 after study intervention administration)", "description"=>"pIMDs are a subset of adverse events of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["RSV", "Respiratory Syncytial Virus", "RSVPreF3 OA vaccine", "Immunogenicity", "Safety", "Reactogenicity", "At increased risk (AIR)", "Older Adults", "Respiratory syncytial virus lower respiratory tract disease (RSV-LRTD)"], "conditions"=>["Respiratory Syncytial Virus Infections"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of the study is to evaluate the immunogenicity and safety of a single dose of investigational RSVPreF3 OA vaccine in Indian older adults 60 years of age (YOA) and above and Indian adults 50-59 YOA at increased risk of RSV-LRTD."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"50 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\nParticipants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n\n• Written or witnessed informed consent obtained from the participant (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.\n\nSpecific inclusion criteria for all participants in Cohort 1 (Older adults)\n\n* Male or female, \\>= 60 YOA at the time of the study intervention administration.\n* Participants who are medically stable in the opinion of the investigator at the time of study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.\n* Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living.\n\nSpecific inclusion criteria for all participants in Cohort 2 (Adults-AIR)\n\n* Male or female, 50-59 YOA at the time of the study intervention administration.\n* Participants should be diagnosed with at least 1 of the following medical conditions and considered medically stable by the investigator:\n* Chronic pulmonary disease resulting in activity restricting symptoms or use of long term medication:\n\n * Chronic obstructive pulmonary disease (COPD)\n * Asthma\n * Cystic fibrosis\n * Other chronic respiratory diseases: lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema, or bronchiectasis\n* Chronic cardiovascular disease:\n\n * Chronic heart failure (CHF)\n * Pre-existing coronary artery disease (CAD not otherwise specified)\n * Cardiac arrhythmia\n* Diabetes mellitus: type 1 or type 2\n\nOther diseases at increased risk for RSV-LRTD disease:\n\n* Chronic kidney disease\n* Chronic liver disease\n\n * Female participants of non-childbearing potential may be enrolled in the study. Non childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or post-menopause.\n * Female participants of childbearing potential may be enrolled in the study if the participant\n* has practiced adequate contraception from 1 month prior to study intervention administration, and\n* has a negative pregnancy test on the day of and prior to study intervention administration, and\n* has agreed to continue adequate contraception for at least 1 month after the study intervention administration.\n\nExclusion Criteria:\n\nMedical Conditions\n\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, resulting from disease (e.g. current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).\n* Unstable chronic illness.\n* Recurrent history or uncontrolled neurological disorders or seizures. Participants with medically-controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol (e.g. completion of the eDiary, attend phone call/study site visits).\n* Any history of dementia or any medical condition that moderately or severely impairs cognition.\n* Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease).\n* Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.\n* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.\n\nPrior/Concomitant Therapy\n\n* Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days (Day -29 to Day 1) before the dose of study interventions or their planned use during the study period (Day 1 up to Month 6).\n* Previous vaccination with licensed or investigational RSV vaccine. Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines (fully licensed or with emergency use authorization \\[EUA\\]) which can be administered up to 14 days before or from 14 days after the study intervention administration.\n* Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.\n\n * Up to 3 months prior to the study intervention administration:\n * For corticosteroids, this will mean prednisone equivalent \\>= 20 mg/day for adult participants. Inhaled and topical steroids are allowed.\n * Administration of immunoglobulins and/or any blood products or plasma derivatives.\n * Up to 6 months prior to study intervention administration: long-acting immune modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.\n\nPrior/Concurrent Clinical Study Experience\n\n• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).\n\nOther Exclusion Criteria for all participants\n\n* History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.\n* Participation of any study personnel or their immediate dependents, family, or household members.\n* Planned move during the study conduct that prohibits participation until study end.\n* Bedridden participants.\n\nOther Exclusion Criteria for cohort 2 (Adults-AIR)\n\n* Pregnant or lactating female participant.\n* Female participant planning to become pregnant or planning to discontinue contraceptive precautions."}, "identificationModule"=>{"nctId"=>"NCT06614725", "briefTitle"=>"A Study in India on the Immune Response and Safety of a Respiratory Syncytial Virus (RSV) Older Adults (OA) Vaccine When Given to Older Adults 60 Years of Age and Above and Adults 50-59 Years of Age at Increased Risk (AIR) of Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV-LRTD)", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"GlaxoSmithKline"}, "officialTitle"=>"A Phase 3, Randomized, Placebo-controlled, Observer-blind Study in India to Evaluate Immune Response, Reactogenicity and Safety of a Single Intramuscular Dose of RSVPreF3 OA Investigational Vaccine When Administered to Older Adults >=60 Years of Age and Adults 50-59 Years of Age at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease", "orgStudyIdInfo"=>{"id"=>"221265"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"OA-RSV Group", "description"=>"Older adults (OA) participants, 60 YOA and above, will receive a single dose of RSVPreF3 OA investigational vaccine at Day 1 and will be followed up until end of study (6 months post vaccine dose administration).", "interventionNames"=>["Biological: RSVPreF3 OA investigational vaccine"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"OA-Placebo Group", "description"=>"OA participants will receive a single dose of placebo at Day 1 and will be followed up until end of study (6 months post vaccine dose administration).", "interventionNames"=>["Combination Product: Placebo"]}, {"type"=>"EXPERIMENTAL", "label"=>"Adults-AIR-RSV Group", "description"=>"Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, will receive a single dose of RSVPreF3 OA investigational vaccine at Day 1 and will be followed up until end of study (6 months post vaccine dose administration).", "interventionNames"=>["Biological: RSVPreF3 OA investigational vaccine"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Adults-AIR-Placebo Group", "description"=>"Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, will receive a single dose of placebo at Day 1 and will be followed up until end of study (6 months post vaccine dose administration).", "interventionNames"=>["Combination Product: Placebo"]}], "interventions"=>[{"name"=>"RSVPreF3 OA investigational vaccine", "type"=>"BIOLOGICAL", "description"=>"1 dose of RSVPreF3 OA investigational vaccine administered intramuscularly on Day 1 to participants in OA-RSV and Adults-AIR-RSV groups.", "armGroupLabels"=>["Adults-AIR-RSV Group", "OA-RSV Group"]}, {"name"=>"Placebo", "type"=>"COMBINATION_PRODUCT", "description"=>"1 dose of placebo (saline solution) administered intramuscularly on Day 1 to participants in OA-Placebo and Adults-AIR-Placebo groups.", "armGroupLabels"=>["Adults-AIR-Placebo Group", "OA-Placebo Group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"380015", "city"=>"Ahmedabad", "status"=>"RECRUITING", "country"=>"India", "contacts"=>[{"name"=>"US GSK Clinical Trials Call Center", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"877-379-3718"}, {"name"=>"EU GSK Clinical Trials Call Centre", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"+44 (0) 20 8990 4466"}, {"name"=>"Vinay Bhomia", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"GSK Investigational Site", "geoPoint"=>{"lat"=>23.02579, "lon"=>72.58727}}, {"zip"=>"380061", "city"=>"Ahmedabad", "status"=>"RECRUITING", "country"=>"India", "contacts"=>[{"name"=>"US GSK Clinical Trials Call Center", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"877-379-3718"}, {"name"=>"EU GSK Clinical Trials Call Centre", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"+44 (0) 20 8990 4466"}, {"name"=>"Kiran Rami", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"GSK Investigational Site", "geoPoint"=>{"lat"=>23.02579, "lon"=>72.58727}}, {"zip"=>"202002", "city"=>"Aligarh", "status"=>"RECRUITING", "country"=>"India", "contacts"=>[{"name"=>"US GSK Clinical Trials Call Center", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"877-379-3718"}, {"name"=>"EU GSK Clinical Trials Call Centre", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"+44 (0) 20 8990 4466"}, {"name"=>"Mohammad Shameem", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"GSK Investigational Site", "geoPoint"=>{"lat"=>27.88145, "lon"=>78.07464}}, {"zip"=>"560002", "city"=>"Bangalore", "status"=>"RECRUITING", "country"=>"India", "contacts"=>[{"name"=>"US GSK Clinical Trials Call Center", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"877-379-3718"}, {"name"=>"EU GSK Clinical Trials Call Centre", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"+44 (0) 20 8990 4466"}, {"name"=>"Aravind G N", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"GSK Investigational Site", "geoPoint"=>{"lat"=>12.97194, "lon"=>77.59369}}, {"zip"=>"590019", "city"=>"Belagavi", "status"=>"RECRUITING", "country"=>"India", "contacts"=>[{"name"=>"US GSK Clinical Trials Call Center", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"877-379-3718"}, {"name"=>"EU GSK Clinical Trials Call Centre", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"+44 (0) 20 8990 4466"}, {"name"=>"R G Viveki", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"GSK Investigational Site"}, {"zip"=>"734012", "city"=>"Darjeeling", "status"=>"RECRUITING", "country"=>"India", "contacts"=>[{"name"=>"US GSK Clinical Trials Call Center", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"877-379-3718"}, {"name"=>"EU GSK Clinical Trials Call Centre", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"+44 (0) 20 8990 4466"}, {"name"=>"Dipanjan Bandyopadhyay", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"GSK Investigational Site", "geoPoint"=>{"lat"=>27.03333, "lon"=>88.26667}}, {"zip"=>"110060", "city"=>"Delhi", "status"=>"RECRUITING", "country"=>"India", "contacts"=>[{"name"=>"US GSK Clinical Trials Call Center", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"877-379-3718"}, {"name"=>"EU GSK Clinical Trials Call Centre", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"+44 (0) 20 8990 4466"}, {"name"=>"Subhash Chandra Bharija", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"GSK Investigational Site", "geoPoint"=>{"lat"=>28.65195, "lon"=>77.23149}}, {"zip"=>"208002", "city"=>"Kanpur", "status"=>"RECRUITING", "country"=>"India", "contacts"=>[{"name"=>"US GSK Clinical Trials Call Center", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"877-379-3718"}, {"name"=>"EU GSK Clinical Trials Call Centre", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"+44 (0) 20 8990 4466"}, {"name"=>"Saurabh Agarwal", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"GSK Investigational Site", "geoPoint"=>{"lat"=>26.46523, "lon"=>80.34975}}, {"zip"=>"603103", "city"=>"Kelambakkam", "status"=>"RECRUITING", "country"=>"India", "contacts"=>[{"name"=>"US GSK Clinical Trials Call Center", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"877-379-3718"}, {"name"=>"EU GSK Clinical Trials Call Centre", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"+44 (0) 20 8990 4466"}, {"name"=>"Durga Krishnan", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"GSK Investigational Site", "geoPoint"=>{"lat"=>12.78725, "lon"=>80.22161}}, {"zip"=>"682026", "city"=>"Kochi", "status"=>"RECRUITING", "country"=>"India", "contacts"=>[{"name"=>"US GSK Clinical Trials Call Center", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"877-379-3718"}, {"name"=>"EU GSK Clinical Trials Call Centre", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"+44 (0) 20 8990 4466"}, {"name"=>"Dipu Sathyapalan", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"GSK Investigational Site", "geoPoint"=>{"lat"=>9.93988, "lon"=>76.26022}}, {"zip"=>"700073", "city"=>"Kolkata", "status"=>"RECRUITING", "country"=>"India", "contacts"=>[{"name"=>"US GSK Clinical Trials Call Center", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"877-379-3718"}, {"name"=>"EU GSK Clinical Trials Call Centre", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"+44 (0) 20 8990 4466"}, {"name"=>"Santanu Munshi", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"GSK Investigational Site", "geoPoint"=>{"lat"=>22.56263, "lon"=>88.36304}}, {"zip"=>"411043", "city"=>"Pune-411 043", "status"=>"RECRUITING", "country"=>"India", "contacts"=>[{"name"=>"US GSK Clinical Trials Call Center", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"877-379-3718"}, {"name"=>"EU GSK Clinical Trials Call Centre", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"+44 (0) 20 8990 4466"}, {"name"=>"Sonali Palkar", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"GSK Investigational Site", "geoPoint"=>{"lat"=>18.51957, "lon"=>73.85535}}, {"city"=>"Raipur", "status"=>"RECRUITING", "country"=>"India", "contacts"=>[{"name"=>"US GSK Clinical Trials Call Center", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"877-379-3718"}, {"name"=>"EU GSK Clinical Trials Call Centre", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"+44 (0) 20 8990 4466"}, {"name"=>"Manoj Lahoti", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"GSK Investigational Site", "geoPoint"=>{"lat"=>21.23333, "lon"=>81.63333}}, {"zip"=>"532001", "city"=>"Srikakulam", "status"=>"RECRUITING", "country"=>"India", "contacts"=>[{"name"=>"US GSK Clinical Trials Call Center", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"877-379-3718"}, {"name"=>"EU GSK Clinical Trials Call Centre", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"+44 (0) 20 8990 4466"}, {"name"=>"K Sunil Naik", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"GSK Investigational Site", "geoPoint"=>{"lat"=>16.19645, "lon"=>80.84671}}, {"zip"=>"412216", "city"=>"Vadu Budruk Pune", "status"=>"RECRUITING", "country"=>"India", "contacts"=>[{"name"=>"US GSK Clinical Trials Call Center", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"877-379-3718"}, {"name"=>"EU GSK Clinical Trials Call Centre", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"+44 (0) 20 8990 4466"}, {"name"=>"Dr. Anand S Kawade", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"GSK Investigational Site"}], "centralContacts"=>[{"name"=>"US GSK Clinical Trials Call Center", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"877-379-3718"}, {"name"=>"EU GSK Clinical Trials Call Center", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"+44 (0) 20 89904466"}]}, "ipdSharingStatementModule"=>{"url"=>"https://www.gsk.com/en-gb/innovation/trials/data-transparency/", "infoTypes"=>["STUDY_PROTOCOL", "SAP", "ICF", "CSR"], "timeFrame"=>"Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.", "ipdSharing"=>"YES", "description"=>"Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/", "accessCriteria"=>"Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"GlaxoSmithKline", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}