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"}}},"trialDetailsJson":{"title":"Details Page","returnSearch":"Back to search results","description":"Study Description","identifier":"ViiV Study ID","clinicalID":"Clinicaltrials.gov Identifier","EudraCtID":"EudraCT Number","resultsAvailable":"Has Results Available Below","docAvailable":"Has Results Document Available","studyOverview":"Study Overview","overviewSection":{"conditionsDisplay":"Medical Conditions","product":"Product","collaborators":"Collaborators","dates":"Date","studyType":"Type","phase":"Phase","gender":"Gender","age":"Age","acceptVolunteers":"Accepts Healthy Volunteers"},"studyDocuments":"Study Documents","noDocuments":"No documents available","studyDocumentsAdditionalText":"If you wish to request for Full Study Report, please contact - ","studyDocumentsAdditionalEmail":"GSKClinicalSupportHD@gsk.com","isReleased":{"firstPart":"This study has Protocol and Result summary on ClinicalTrial.gov. Click","secondPart":"to learn more.","linkText":"here"},"mapLocations":"Locations","centralContact":"Central Contact","centralPhone":"Central Contact Phone","centralEmail":"Central Contact Email","mapSection":{"site":"GSK Investigational Site","condition":"Condition","id":"Study ID","city":"City","state":"State","zip":"Zip","country":"Country"},"studyDesign":"Study Design","designSection":{"purpose":"Primary Purpose","allocation":"Allocation","study_design":"Study Design","study_classification":"Study Classification","masking":"Masking","masked_subject":"Masked Subject","masked_caregiver":"Masked Caregiver","masked_investigator":"Masked Investigator","masked_assessor":"Masked Assessor","primary_outcomes":"Primary Outcomes","secondary_outcomes":"Secondary Outcomes","arms":"Arms","interventions":"Interventions","keyword":"Keyword","inclusionTitle":"Inclusion Criteria","exclusionTitle":"Exclusion Criteria","criteriaText":"Inclusion/Exclusion Criteria","criteria_button":"Click to view inclusion/exclusion criteria","enrollment":"Enrollment","clinicalPublications":"Clinical Publications"},"popoversText":{"studyId":{"childMarkdownRemark":{"html":"A unique number for a study given by ViiV.
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","IpdInfoTypeAnalyticCode":"","IpdInfoTypeIcf":"","IpdInfoTypeCsr":"","IpdInfoTypeProtocol":"","IpdInfoTypeSap":"","IpdTimeFrame":"","IpdUrl":"http://","IsFlexibleTrial":false,"IsReleasedToCtGov":"true","MaskingInfo":{"masked_assessor":"false","masked_caregiver":"false","masked_investigator":"false","masked_subject":"false","masking_description":"","no_masking":"true"},"PatientLevelData":"true","SharingIpd":"Yes","acronym":"","allocation":"Randomized","arm_groups":[{"arm_group_label":"GSK2202083A GROUP","arm_group_description":"Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.","arm_type":"Experimental"},{"arm_group_label":"INFANRIX + MENJUGATE GROUP","arm_group_description":"Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.","arm_type":"Active Comparator"}],"assignment":"Parallel Assignment","brief_summary":"This study will evaluate the safety and immunogenicity of GSK Biologicals’ GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Feasibility study of GlaxoSmithKline Biologicals’ GSK2202083A vaccine in healthy infants at 3, 5 and 11 months of age.","conditions":null,"created_date":"05/07/2021 12:30:29","criteria":"Inclusion Criteria:\n•\tA male or female infant between, and including, 8 and 16 weeks at the time of the first vaccination.\n•\tBorn after a gestation period of 36 to 42 weeks inclusive.\n•\tSubjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol.\n•\tWritten informed consent obtained from the parent or guardian of the subject.\n•\tHealthy subjects as established by medical history and clinical examination before entering into the study.\n\n\nExclusion Criteria:\n•\tUse of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. \n•\tChronic administration of immunosuppressants or other immune-modifying drugs since birth.\n•\tAdministration of immunoglobulins and/or any blood products since birth or planned administration during the study period. \n•\tAdministration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to study Visit 3, or from 30 days before to 30 days after study Visit 4, with the exception of influenza and human rotavirus vaccines. The administration of other vaccines, including conjugated pneumococcal vaccine, is allowed during the period from one day after study Visit 3 to 31 days before study Visit 4.\n•\tConcurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product\n•\tEvidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib and/or MenC vaccination or disease, including HBV vaccination at birth.\n•\tHistory of seizures or progressive neurological disease.\n•\tAny confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n•\tHistory of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).\n•\tMajor congenital defects or serious chronic illness.\nThe following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:\n•\tCurrent febrile illness or axillary temperature >= 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 2","display_phase_internal":"PHASE_2","display_status":"Completed","display_status_internal":"RECSTATUS_I_COMPLETED","endpoint":"","enrollment":"16","exclusion":"","gender":"All","gender_based":"","gender_description":"","healthy_volunteers":"Yes","id":"1b071a28-3c7c-5058-b191-de30446324fe","internal":{"content":null,"contentDigest":"3962692f6ae258c3c346813eefc5969f","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria:\n•\tA male or female infant between, and including, 8 and 16 weeks at the time of the first vaccination.\n•\tBorn after a gestation period of 36 to 42 weeks inclusive.\n•\tSubjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol.\n•\tWritten informed consent obtained from the parent or guardian of the subject.\n•\tHealthy subjects as established by medical history and clinical examination before entering into the study.\n\n\nExclusion Criteria:\n•\tUse of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. \n•\tChronic administration of immunosuppressants or other immune-modifying drugs since birth.\n•\tAdministration of immunoglobulins and/or any blood products since birth or planned administration during the study period. \n•\tAdministration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to study Visit 3, or from 30 days before to 30 days after study Visit 4, with the exception of influenza and human rotavirus vaccines. The administration of other vaccines, including conjugated pneumococcal vaccine, is allowed during the period from one day after study Visit 3 to 31 days before study Visit 4.\n•\tConcurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product\n•\tEvidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib and/or MenC vaccination or disease, including HBV vaccination at birth.\n•\tHistory of seizures or progressive neurological disease.\n•\tAny confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n•\tHistory of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).\n•\tMajor congenital defects or serious chronic illness.\nThe following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:\n•\tCurrent febrile illness or axillary temperature >= 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration","interventions":[{"arm_group_label":"GSK2202083A GROUP","intervention_description":"Intramuscular, three doses","intervention_name":"GSK2202083A vaccine","intervention_type":"Biological/Vaccine"},{"arm_group_label":"INFANRIX + MENJUGATE GROUP","intervention_description":"Intramuscular, three doses","intervention_name":"Infanrix hexa","intervention_type":"Biological/Vaccine"},{"arm_group_label":"INFANRIX + MENJUGATE GROUP","intervention_description":"Intramuscular, two doses","intervention_name":"Menjugate","intervention_type":"Biological/Vaccine"}],"interventional_subtype":"Prevention","is_fda_regulated":true,"is_high_value":false,"is_ind_study":false,"keywords":[],"last_follow_up_date":"06/25/2009 00:00:00","links":[{"description":"Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.","url":"https://www.clinicalstudydatarequest.com"}],"locations":[],"masking":"","maximum_age_raw":"16 weeks","maximum_age":"16","minimum_age":"8","minimum_age_raw":"8 weeks","modified_date":"05/10/2021 08:53:35","number_of_arms":"2","observational_design":{"biospecimen_description":"","biospecimen_retention":"","number_of_groups":"","observational_study_design":"","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":""},"official_title":"Feasibility study of GlaxoSmithKline Biologicals’ GSK2202083A vaccine in healthy infants at 3, 5 and 11 months of age.","org_study_id":"111761","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Completed - Interventional","oversight_info":{"exported_from_us":"","fda_regulated_device":"","fda_regulated_drug":"","ped_postmarket_surv":"","has_dmc":null,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"Phase 2","primary_compl_date":"06/25/2009 00:00:00","primary_outcomes":[{"outcome_description":"As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done.","outcome_measure":"Anti-PRP antibody concentrations ≥ 0.15 mg/mL","outcome_time_frame":"At Month 3","outcome_safety_issue":null}],"product_name":"Combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis, Haemophilus influenzae type b and Neisseria meningitidis conjugate vaccine (GSK2202083A) Combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis, Haemophilus influenzae type b and Neisseria meningitidis conjugate vaccine (GSK2202083A) Combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis, Haemophilus influenzae type b and Neisseria12345","product_name_OneLinkTx":"","secondary_ids":[{"id":"2008-006365-91","id_type":"EudraCT Number","id_domain":""}],"secondary_outcomes":[{"outcome_description":"The solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. Subjects from Control Group did not receive the second study vaccination dose due to study termination.","outcome_measure":"Number of subjects with any, grade 3 and related solicited local symptoms","outcome_time_frame":"During the 8-day (Days 0-7) post-vaccination period following each dose and across doses","outcome_safety_issue":null},{"outcome_description":"The solicited general symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = any general symptom irrespective of intensity grade and relationship to vaccination. Grade 3 Irritability = crying that could not be comforted/prevented normal activity. Grade 3 Drowsiness = drowsiness that prevented normal activity. Grade 3 Loss of Appetite = did not eat at all. Related = symptoms assessed by the investigator as causally related to vaccination. Subjects from Control Group did not receive the second study vaccination dose due to study termination.","outcome_measure":"Number of subjects with any, grade 3 and related solicited general symptoms","outcome_time_frame":"During the 8-day (Days 0-7) post-vaccination period following each dose and across doses","outcome_safety_issue":null},{"outcome_description":"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.","outcome_measure":"Number of subjects with unsolicited adverse events AE(s)","outcome_time_frame":"During the 31-day (Days 0-30) post-vaccination period","outcome_safety_issue":null},{"outcome_description":"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.","outcome_measure":"Number of subjects with serious adverse events (SAEs)","outcome_time_frame":"During the entire study period (from Month 0 to Month 9)","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":[]},"start_date":"04/06/2009 00:00:00","study_type":"Interventional","therapeutic_area":"Vaccines Prophylactic","citations":[],"is_section_801":true}},"pageContext":{"studyId":"111761"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}