CLINICAL TRIALS PROFILE FOR ROTATEQ
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All Clinical Trials for ROTATEQ
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01259765 ↗ | Llama Antibody, Rotavirus Diarrhoea, Children | Completed | Unilever Nederland Holdings | Phase 2 | 2006-01-01 | The investigators hypothesize that : oral administration of VHH batch 203027 will be - safe and tolerable for healthy Bangladeshi humans of all age groups (Part I) - effective in reducing severity of diarrhoea in children with proven rotavirus infection (Part II). This entry only covers Part II. |
| NCT01259765 ↗ | Llama Antibody, Rotavirus Diarrhoea, Children | Completed | International Centre for Diarrhoeal Disease Research, Bangladesh | Phase 2 | 2006-01-01 | The investigators hypothesize that : oral administration of VHH batch 203027 will be - safe and tolerable for healthy Bangladeshi humans of all age groups (Part I) - effective in reducing severity of diarrhoea in children with proven rotavirus infection (Part II). This entry only covers Part II. |
| NCT01375907 ↗ | Safety Study of a Rotavirus Vaccine (Rotavin-M1) Among Healthy Adults | Completed | Center for Research and Production of Vaccines and Biologicals | Phase 1 | 2009-08-01 | The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam. |
| NCT01375907 ↗ | Safety Study of a Rotavirus Vaccine (Rotavin-M1) Among Healthy Adults | Completed | National Institute of Hygiene and Epidemiology, Vietnam | Phase 1 | 2009-08-01 | The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam. |
| NCT02028910 ↗ | Efficacy of Ondansetron on Vomiting Due to Acute Gastroenteritis in Pediatric During Winter | Terminated | Assistance Publique - Hôpitaux de Paris | Phase 3 | 2014-01-01 | Acute gastroenteritis is a common disease especially in children. With bronchiolitis and influenza, she participated widely in weight of winter epidemics that causes problems every year our health care system, particularly in the pediatric emergency and inpatient since they are the second leading cause of hospitalization in children. The main symptoms of viral acute gastroenteritis are diarrhea and vomiting which exposes children to the risk of sometimes severe dehydration, the most common cause of hospitalization. There is no specific treatment for these infections. At most, there is a vaccine against severe rotavirus diarrhea (Rotarix ® and RotaTeq ®), but does not yet official recommendations to use in France. The treatment of acute gastroenteritis virus is symptomatic and is generally based on the use of oral rehydration solutions (ORS) whose administration is limited by the frequent presence of vomiting. Until now, no treatment has demonstrated its effectiveness on vomiting due to acute gastroenteritis virus in children. Conventional anti-emetics, widely prescribed, are ineffective in practice, very few studies in this indication and encumbered side effects. Several drugs have long been used in children to fight against severe vomiting associated with the administration of anti-cancer chemotherapy, such as granisetron (Kytril ®) and ondansetron (Zofren ®). The mechanism of action of these molecules is well known. They act both on the enteric nervous system by blocking serotonin receptors. Several placebo-controlled trials suggest that ondansetron is effective in reducing the number of vomiting in children emergency consultant for acute gastroenteritis. However, the method used in these tests and the number of children enrolled has not yet demonstrated the efficacy of ondansetron on the number of admissions, the number of emergency and return the cost / benefit ratio of this treatment. In addition, several studies reported the occurrence of watery stools more frequently in children treated with the placebo group. Evidence that ondansetron is well tolerated and effective for reducing the severity of vomiting during acute gastroenteritis pediatrics winter could support the use of this treatment in routine pediatric emergencies. This study is a clinical trial, multicenter, controlled versus placebo whose main objective is to evaluate the efficacy of ondansetron to decrease the intensity of vomiting in children with acute gastroenteritis during winter emergencies Upon arrival to the emergency room after signing. Consent, an ECG is performed in eligible patients. Children meet all the criteria for inclusion and non-inclusion receive, at random, one of two treatments: ondansetron (active) or placebo. The study does not alter the usual care of the child to the emergency room. After passing emergency, patients will be followed in the study for 8 days, through a phone call home to J3 and J7. The total duration of patient participation in the study is 8 days, including 4 hours emergencies (usual transit time to emergencies). |
| NCT02542462 ↗ | Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study | Completed | Centers for Disease Control and Prevention | Phase 4 | 2015-11-01 | This is a prospective randomized clinical trial that aims to evaluate the potential effects of the first dose of rotavirus vaccines on gastrointestinal motility and anatomy and blood and stool cytokine responses. It will also assess the association between these outcomes and the pattern of the shedding of vaccine strain rotavirus in the stool. Infants will be randomized to one of four arms: monovalent rotavirus vaccine (Rotarix®, RV1) alone, RV1 with other recommended vaccines, pentavalent rotavirus vaccine (RotaTeq®, RV5) alone, or RV5 with other recommended vaccines. Data derived from the pilot study will be used to assess the feasibility of conducting a larger scale study. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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Clinical Trial Sponsors for ROTATEQ
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| Sponsor Name for ROTATEQ | |
| Sponsor | Trials |
| International Centre for Diarrhoeal Disease Research, Bangladesh | 1 |
| Center for Research and Production of Vaccines and Biologicals | 1 |
| National Institute of Hygiene and Epidemiology, Vietnam | 1 |
| [disabled in preview] | 3 |
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