[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100099115":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":51,"centralContacts":36,"locations":36,"responsibleParty":55,"collaborators":36,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":36,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":36,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":36,"overallStatus":77,"whyStopped":36,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":36},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"AR51 (12, 10)","EXPERIMENTAL","Participants were vaccinated with 0.5 ml of AR51 (12,10) formulation via intramuscular injection as a primary series at 2, 4, and 6 months of age, and as a booster at 12 to 14 months of age.",[13],"Biological: AR51 (12, 10)",{"label":15,"type":10,"description":16,"interventionNames":17},"PR51 (3, 10)","Participants were vaccinated with 0.5 ml of PR51 (3,10) formulation via intramuscular injection as a primary series at 2, 4, and 6 months of age, and as a booster at 12 to 14 months of age.",[18],"Biological: PR51 (3, 10)",{"label":20,"type":10,"description":21,"interventionNames":22},"PR51 (6, 10)","Participants were vaccinated with 0.5 ml of PR51 (6,10) formulation via intramuscular injection as a primary series at 2, 4, and 6 months of age, and as a booster at 12 to 14 months of age.",[23],"Biological: PR51 (6, 10)",{"label":25,"type":26,"description":27,"interventionNames":28},"PENTACEL™ + RECOMBIVAX HB™","ACTIVE_COMPARATOR","Participants were vaccinated with 0.5 ml each of PENTACEL™ + RECOMBIVAX HB™ via intramuscular injection as a primary series at 2, 4, and 6 months of age, and with 0.5 ml PENTACEL™ as a booster at 12 to 14 months of age.",[29,30],"Biological: PENTACEL™","Biological: RECOMBIVAX HB™",[32,37,40,43,47],{"type":33,"name":9,"description":34,"armGroupLabels":35,"otherNames":36},"BIOLOGICAL","vaccine formulation containing 12 mcg of PRP-T and 10 mcg of HBsAg",[9],null,{"type":33,"name":15,"description":38,"armGroupLabels":39,"otherNames":36},"vaccine formulation containing 3 mcg of PRP-OMPC and 10 mcg of HBsAg",[15],{"type":33,"name":20,"description":41,"armGroupLabels":42,"otherNames":36},"vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg",[20],{"type":33,"name":44,"description":45,"armGroupLabels":46,"otherNames":36},"PENTACEL™","licensed vaccine for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b, administered open-label",[25],{"type":33,"name":48,"description":49,"armGroupLabels":50,"otherNames":36},"RECOMBIVAX HB™","licensed vaccine for hepatitis, administered open-label",[25],[52],{"name":53,"affiliation":5,"role":54},"Medical Monitor","STUDY_DIRECTOR",{"type":56,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100099115","phase-2-a-study-of-the-safety-and-tolerability-of-v419-in-healthy-infants-at-24-6-and-12-to-14-months-of-age-v419-003-100099115",false,"NCT00551915","A Study of the Safety and Tolerability of V419 in Healthy Infants at 2,4, 6 and 12 to 14 Months of Age (V419-003)","Safety, Tolerability, and Immunogenicity of 3 Different Formulations of a Liquid Hexavalent Combination Vaccine, HR5I When Administered to Healthy Hepatitis B Vaccine-Naive Infants at 2, 4, 6, and 12-14 Months of Age","Inclusion Criteria:\n\n* Healthy infants 2 months of age who have not received prior vaccinations for Haemophilus influenzae type b (Hib), hepatitis B, Diptheria\u002FPertussis\u002FTetanus (DPT), or Polio\n\nExclusion Criteria:\n\n* HIV infection in participant (child\u002Fmother)\n* Documented HBsAg seropositivity in the participant (child or mother)\n* History of invasive Hib disease, hepatitis B, diphtheria, tetanus, pertussis, or poliovirus infection\n* History of seizure disorder\n* Underlying medical conditions such as inborn errors of metabolism, failure to thrive, or any major congenital abnormalities requiring surgery\n* Prior or anticipated receipt of immune globulin, blood, or blood products\n* Known hypersensitivity to any component of the investigational or marketed vaccines being administered in this protocol\n* Any history or condition that would exclude the participant from receiving any vaccine administered under this protocol based on the contraindications that appear in the package circulars for each component of these vaccines\n* Any condition that, in the opinion of the investigator, is not stable or may interfere with the evaluation of the study objectives",true,"ALL","6 Weeks","9 Weeks",{"count":69,"type":70},756,"ACTUAL","INTERVENTIONAL",[73],"PHASE2","The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 3 formulations of the HR5I vaccine (Haemophilus influenzae type b conjugate, recombinant hepatitis B surface antigen, diphtheria, tetanus, 5-component acellular pertussis, and inactivated poliovirus Types 1, 2, and 3). The primary hypothesis is that at least 1 of the 3 formulations of HR5I administered as a primary series at 2, 4, and 6 months of age will be acceptable (similar to targeted rates) with respect to Postdose 3 antibody responses to all antigens.",[76],"Bacterial Infections; Virus Diseases","COMPLETED","2015-10-29",{"date":80,"type":81},"2015-10-30","ESTIMATED",{"date":83,"type":36},"2001-05",{"date":85,"type":70},"2003-01",{"name":5,"class":6}]