Nctid:
NCT00000829
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-17"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000003141", "term"=>"Communicable Diseases"}, {"id"=>"D000011008", "term"=>"Pneumococcal Infections"}], "ancestors"=>[{"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000013290", "term"=>"Streptococcal Infections"}, {"id"=>"D000016908", "term"=>"Gram-Positive Bacterial Infections"}, {"id"=>"D000001424", "term"=>"Bacterial Infections"}, {"id"=>"D000001423", "term"=>"Bacterial Infections and Mycoses"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M13898", "name"=>"Pneumococcal Infections", "asFound"=>"Pneumococcal Infections", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M16080", "name"=>"Streptococcal Infections", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M19252", "name"=>"Gram-Positive Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000014612", "term"=>"Vaccines"}, {"id"=>"D000069443", "term"=>"Heptavalent Pneumococcal Conjugate Vaccine"}], "ancestors"=>[{"id"=>"D000007155", "term"=>"Immunologic Factors"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M17360", "name"=>"Vaccines", "asFound"=>"Other", "relevance"=>"HIGH"}, {"id"=>"M412", "name"=>"Heptavalent Pneumococcal Conjugate Vaccine", "asFound"=>"Previously Treated", "relevance"=>"HIGH"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"count"=>60}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1999-10", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-27", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-10-28", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Comparison of adverse reactions between PCV and placebo patients that occur within 48 hours after each injection", "timeFrame"=>"Throughout study"}, {"measure"=>"Comparison of seroconversion rates and changes in (IgG) ELISA antibody levels between PCV and placebo patients after the primary series", "timeFrame"=>"Throughout study"}], "secondaryOutcomes"=>[{"measure"=>"Comparison of booster rates in serum ELISA (IgG) antibody levels just before the 4th vaccination and one month after the 4th vaccination in children receiving PCV and placebo", "timeFrame"=>"Prior to 4th vaccination and at 1 month after 4th vaccination"}, {"measure"=>"Comparison of serum IgG1 and IgG2 subclass and IgA type specific seroconversion rates and changes in antibody levels in response to the primary immunization series and booster vaccination between PCV and placebo patients", "timeFrame"=>"Throughout study"}, {"measure"=>"To compare the decline of serum total IgG, IgG1, IgG2, and IgA pneumococcal type specific antibody after the 3rd and after the 4th vaccination in PCV versus placebo patients", "timeFrame"=>"At a time after the 3rd vaccination and at a time after the 4th vaccination"}, {"measure"=>"Modeling of the rates of seroconversion and changes in serum antibody levels in PCV patients, after the primary series and booster series, to clinical HIV staging and T-lymphocyte parameters, as well as B-lymphocyte parameters", "timeFrame"=>"Throughout study"}]}, "conditionsModule"=>{"keywords"=>["Vaccines, Synthetic", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Pneumococcal Infections", "Bacterial Vaccines"], "conditions"=>["HIV Infections", "Pneumococcal Infections"]}, "descriptionModule"=>{"briefSummary"=>"To assess whether HIV-infected infants who receive a heptavalent pneumococcal conjugate vaccine have more local reactions at the site of injection and systemic reactions than placebo subjects. To assess whether this vaccine is more immunogenic than placebo following the third vaccination.\n\nChildren with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein.", "detailedDescription"=>"Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein.\n\nInfants are randomized to receive either heptavalent pneumococcal conjugate vaccine or placebo by intramuscular injection at study months 0, 2, and 4, and then at 15 months of age. Additionally, patients receive PNU-IMUNE 23 ( pneumococcal polyvalent vaccine ) at 24 months of age."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"6 months", "minimumAge"=>"2 months", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Antipyretics for rectal temperature \\>= 100.4 F.\n* Antiretroviral therapy.\n\nPatients must have:\n\n* HIV positivity.\n* Birth weight at least 1800 g (3.75 lb).\n* Consent and compliance of parent or guardian.\n\nNOTE:\n\n* Coenrollment in other therapeutic protocols (except ACTG 218, 230, and 279) is permitted.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Enrollment in HIV vaccine trials.\n* Major congenital anomalies that are incapacitating, result in immunologic abnormalities, or require major surgical procedures.\n* Congenital immunoglobulin deficiency, SS or SC hemoglobinopathy, or asplenia.\n* Hypogammaglobulinemia.\n\nConcurrent Medication:\n\nExcluded:\n\n* Prophylactic antipyretics.\n\nPatients with the following prior conditions are excluded:\n\nAcute moderate to severe intercurrent illness or fever within 72 hours prior to study entry.\n\nPrior Medication:\n\nExcluded:\n\n* Any prior pneumococcal vaccine.\n* Measles vaccine within 1 month prior to study vaccination.\n* Any other routine vaccine within 1 week prior to study vaccination.\n* Any immunosuppressant agent, including prednisone, for more than 6 weeks.\n\nPrior Treatment:\n\nExcluded:\n\n* Blood products within 56 days prior to study vaccination."}, "identificationModule"=>{"nctId"=>"NCT00000829", "briefTitle"=>"A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants", "orgStudyIdInfo"=>{"id"=>"ACTG 292"}, "secondaryIdInfos"=>[{"id"=>"11268", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"1", "description"=>"Patients receiving intramuscular heptavalent pneumococcal conjugate vaccine", "interventionNames"=>["Biological: Pneumococcal Vaccine, Polyvalent (23-valent)", "Biological: Pneumococcal Conjugate Vaccine, Heptavalent"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"2", "description"=>"Patients receiving placebo vaccine", "interventionNames"=>["Biological: Pneumococcal Vaccine, Polyvalent (23-valent)", "Biological: Placebo"]}], "interventions"=>[{"name"=>"Pneumococcal Vaccine, Polyvalent (23-valent)", "type"=>"BIOLOGICAL", "description"=>"Administered as an injection at 24 months of age", "armGroupLabels"=>["1", "2"]}, {"name"=>"Pneumococcal Conjugate Vaccine, Heptavalent", "type"=>"BIOLOGICAL", "description"=>"Administered as an injection at 0, 2, 4, and 15 months of age", "armGroupLabels"=>["1"]}, {"name"=>"Placebo", "type"=>"BIOLOGICAL", "description"=>"Administered at 0, 2, 4, and 15 months of age", "armGroupLabels"=>["2"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90033", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Usc La Nichd Crs", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"946091809", "city"=>"Oakland", "state"=>"California", "country"=>"United States", "facility"=>"Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.", "geoPoint"=>{"lat"=>37.80437, "lon"=>-122.2708}}, {"zip"=>"920930672", "city"=>"San Diego", "state"=>"California", "country"=>"United States", "facility"=>"UCSD Maternal, Child, and Adolescent HIV CRS", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"94110", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"San Francisco Gen. Hosp.", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"941430105", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"UCSF Pediatric AIDS CRS", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"32209", "city"=>"Jacksonville", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ. of Florida Jacksonville NICHD CRS", "geoPoint"=>{"lat"=>30.33218, "lon"=>-81.65565}}, {"zip"=>"33161", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ. of Miami Ped. Perinatal HIV/AIDS CRS", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"30306", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Cook County Hosp.", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"606143394", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Chicago Children's CRS", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"606371470", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"701122699", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Tulane/LSU Maternal/Child CRS", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"21201", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Univ. of Maryland Med. 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IMPAACT CRS", "geoPoint"=>{"lat"=>40.84985, "lon"=>-73.86641}}, {"zip"=>"11021", "city"=>"Great Neck", "state"=>"New York", "country"=>"United States", "facility"=>"North Shore-Long Island Jewish Health System, Dept. of Peds.", "geoPoint"=>{"lat"=>40.80066, "lon"=>-73.72846}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"NYU Med. Ctr., Dept. of Medicine", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10032", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Columbia IMPAACT CRS", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10032", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Incarnation Children's Ctr.", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10037", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Harlem Hosp. Ctr. NY NICHD CRS", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"Strong Memorial Hospital Rochester NY NICHD CRS", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"zip"=>"117948111", "city"=>"Stony Brook", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY Stony Brook NICHD CRS", "geoPoint"=>{"lat"=>40.92565, "lon"=>-73.14094}}, {"zip"=>"13210", "city"=>"Syracuse", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY Upstate Med. Univ., Dept. of Peds.", "geoPoint"=>{"lat"=>43.04812, "lon"=>-76.14742}}, {"zip"=>"277103499", "city"=>"Durham", "state"=>"North Carolina", "country"=>"United States", "facility"=>"DUMC Ped. CRS", "geoPoint"=>{"lat"=>35.99403, "lon"=>-78.89862}}, {"zip"=>"191044318", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"The Children's Hosp. of Philadelphia IMPAACT CRS", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Texas Children's Hosp. CRS", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"981050371", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"UW School of Medicine - CHRMC", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}, {"zip"=>"009365067", "city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}, {"city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"San Juan City Hosp. PR NICHD CRS", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}], "overallOfficials"=>[{"name"=>"James King, Jr, M.D.", "role"=>"STUDY_CHAIR", "affiliation"=>"University of Maryland, College Park"}, {"name"=>"Sharon Nachman, M.D.", "role"=>"STUDY_CHAIR", "affiliation"=>"SUNY at Stony Brook"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Lederle-Praxis Biologicals", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
