{"id":"placebo-for-rotarix-dose-2","safety":{"commonSideEffects":[]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Placebo has no direct molecular or therapeutic mechanism of action. In clinical trials, it is used as a control arm to measure the efficacy of an active drug by comparison and to account for placebo effect and natural disease progression. Any observed effects in the placebo group are attributed to psychological factors, natural recovery, or trial design artifacts rather than pharmacological activity.","oneSentence":"Placebo is an inert substance with no active pharmacological mechanism; it serves as a control comparator in clinical trials.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:00:58.327Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Control arm in Rotarix (rotavirus vaccine) dose 2 clinical trial"}]},"trialDetails":[{"nctId":"NCT02992197","phase":"PHASE4","title":"The Effects of Increased Inoculum on Oral Rotavirus Vaccine Take and Immunogenicity","status":"COMPLETED","sponsor":"University of Vermont","startDate":"2017-06-12","conditions":"Rotavirus Infection, Vaccine Response Impaired, Vaccine Virus Shedding","enrollment":220},{"nctId":"NCT00420316","phase":"PHASE3","title":"Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-02-12","conditions":"Infections, Rotavirus","enrollment":1613},{"nctId":"NCT00158756","phase":"PHASE3","title":"Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-09-12","conditions":"Hepatitis B","enrollment":308},{"nctId":"NCT01511133","phase":"","title":"Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-04","conditions":"Rotavirus Infection, Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants","enrollment":1},{"nctId":"NCT00329745","phase":"PHASE3","title":"Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-01","conditions":"Infections, Rotavirus","enrollment":8687},{"nctId":"NCT02153333","phase":"","title":"Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following Administration of Rotarix™","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2014-02","conditions":"Infections, Rotavirus","enrollment":1}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":18,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Placebo (for Rotarix dose 2)","genericName":"Placebo (for Rotarix dose 2)","companyName":"University of Vermont","companyId":"university-of-vermont","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Placebo is an inert substance with no active pharmacological mechanism; it serves as a control comparator in clinical trials. Used for Control arm in Rotarix (rotavirus vaccine) dose 2 clinical trial.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}