[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100241994":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":28,"locations":29,"responsibleParty":41,"collaborators":28,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":28,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":28,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":68,"overallStatus":70,"whyStopped":28,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"DTaP-IPV-HB-PRP~T Vaccine","EXPERIMENTAL","All participants will receive 3 doses of 0.5 mL DTaP-IPV-HB-PRP\\~T combined vaccine, intramuscularly, at 2, 3 and 4 months of age (primary series), followed by a booster dose approximately 12 months after the completion of the primary series (at 16 to 17 months of age).",[13],"Biological: Hexaxim®",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Hexaxim®","DTaP-IPV-Hep B-PRP-T combined vaccine, 0.5 mL, Intramuscular",[9],[21,22],"Hexyon®","Hexacima®",[24],{"name":25,"affiliation":26,"role":27},"Medical Director","Sanofi Pasteur SA","STUDY_DIRECTOR",null,[30],{"facility":31,"status":28,"city":32,"state":28,"zip":28,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":28},"Preventive Medicine Centre of Thai Binh Province","Thái Bình","Vietnam","VN",{"type":36,"coordinates":37},"Point",[38,39],106.34002,20.45,{"lat":39,"lon":38},{"type":42,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100241994","phase-3-immunogenicity-and-safety-of-sanofi-pasteurs-combined-vaccine-given-as-a-three-dose-primary-series-at-2-34-months-of-age-and-followed-by-a-booster-dose-given-at-16-to-17-months-of-age-in-vietnamese-infants-who-previously-received-a-dose-of-hepatitis-b-vaccine-at-birth-or-within-1-week-after-birth-100241994",false,"NCT02428491","Immunogenicity and Safety of Sanofi Pasteur's Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth","Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T Combined Vaccine Given as a Three-Dose Primary Series at 2, 3, and 4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth","Inclusion Criteria:\n\n* Aged 61 to 91 days on the day of the first study visit\n* Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥2.5 kg\n* Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)\n* Subject and parent\u002Flegally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures\n* Have received one dose of Hep B vaccine at birth or within 1 week after birth (documented according to the national recommendations).\n\nExclusion Criteria:\n\n* Participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure\n* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any other vaccine within the period from 8 days before to 8 days after each subsequent trial vaccination except for Bacille Calmette Guerin (BCG) vaccination (any administration of oral poliovirus vaccine (OPV) in the context of oral poliovirus vaccine-national immunization days (NIDs) does not fall within the scope of this exclusion criterion)\n* Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (except the dose of Hep B vaccine given at birth or within 1 week after birth) diseases or Haemophilus influenzae type b infection with either the trial vaccine or another vaccine (any administration of OPV in the context of OPV-NIDs does not fall within the scope of this exclusion criterion)\n* Past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)\n* History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections (confirmed either clinically, serologically or microbiologically)\n* Known personal or maternal history of Human Immunodeficiency Virus (HIV), or hepatitis C seropositivity\n* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances\n* Known thrombocytopenia, as reported by the parent\u002Flegally acceptable representative\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination\n* History of seizures\n* In an emergency setting, or hospitalized involuntarily\n* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion\n* Moderate or severe acute illness\u002Finfection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided\n* Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study.",true,"ALL","61 Days","91 Days",{"count":55,"type":56},354,"ACTUAL","INTERVENTIONAL",[59],"PHASE3","The purpose of this study is to describe the immunogenicity and safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T fully liquid combined hexavalent vaccine (Hexaxim®) administered at 2, 3, and 4 months of age and at 16 to 17 months of age in infants and toddlers who received a dose of Hep B vaccine at birth or within 1 week after birth.\n\nPrimary Objective:\n\n* To describe the safety profile after each and all doses of Sanofi-Pasteur's DTaP-IPV-Hep B-PRP-T combined vaccine in Vietnamese infants and toddlers.\n\nSecondary Objective:\n\n* To demonstrate the non-inferiority of the immune response to all antigens induced by the study vaccine in Vietnamese infants one month after the third dose in a 3-dose primary series with the immune response to all antigens induced by the same study vaccine outside Vietnam.\n* To evaluate the immunogenicity of the study vaccine one month after the 3-dose primary series.\n* To describe the persistence of all antibodies before receipt of the booster vaccination.\n* To evaluate the immunogenicity of the study vaccine one month after the booster.",[62,63,64,65,66,67],"Diphtheria","Tetanus","Pertussis","Poliomyelitis","Hepatitis B","Haemophilus Influenzae Type b",[62,63,64,65,66,67,69],"DTaP-IPV-Hep B-PRP-T Combined Vaccine (Hexaxim®)","COMPLETED","2022-03-24",{"date":73,"type":56},"2022-04-05",{"date":75,"type":56},"2015-04-20",{"date":77,"type":56},"2017-01-11",{"name":79,"class":6},"Sanofi Pasteur, a Sanofi Company",1]