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Rotarix Medical Research Studies

Up-to-date List of Rotarix Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Rotarix Medical Research Studies

Rank Status Study
1 Recruiting Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States
Condition: Infections, Rotavirus
Intervention: Procedure: Health Insurance Database
Outcome Measures: Occurrence of medically-attended definite IS as identified from claims database and confirmed through medical record review.;   Occurrence of medically-attended Kawasaki disease as identified from claims database and confirmed through medical record review;   Occurrence of medically-attended convulsions identified from claims database and confirmed through medical record review;   Occurrence of medically-attended acute LRTI hospitalizations identified from claims database;   Occurrence of all-cause deaths identified from claims database
2 Unknown  Evaluation of Universal Rotavirus Vaccination Program
Condition: Gastrointestinal Diseases
Intervention:
Outcome Measures: To evaluate the effectiveness of Rotarix as detected through reduction of burden of illness due to rotavirus gastroenteritis;   To evaluate the implementation of a universal infant rotavirus immunization program with Rotarix
3 Recruiting Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age
Conditions: Neisseria Meningitidis;   Haemophilus Influenzae Type b
Interventions: Biological: Hib-MenCY-TT vaccine (GSK792014);   Biological: Pediarix®;   Biological: Rotarix®;   Biological: Prevnar 13®;   Biological: PedvaxHIB®;   Biological: Havrix®
Outcome Measures: Immunogenicity with respect to components of Hib-MenCY-TT and PedvaxHIB in terms of antibody concentrations;   Immunogenicity with respect to the components of Rotarix in terms of antibody concentrations;   Immunogenicity with respect to the components of Havrix in terms of antibody concentrations;   Immunogenicity with respect to the components of Prevnar 13 in terms of antibody concentrations;   Immunogenicity with respect to the components of the investigational vaccine in terms of antibody concentrations;   Immunogenicity with respect to the components of the investigational vaccine in terms of antibody titers;   Immunogenicity with respect to the components of Havrix in terms of Geometric Mean Concentrations (GMCs);   Occurrence of solicited local and general symptoms;   Occurrence of unsolicited adverse events;   Occurrence of serious adverse events
4 Not yet recruiting A Study of the Interaction Between BCG And MenC Immunisation: BAM
Conditions: BCG Infection;   Reaction - Vaccine;   Immune Response
Interventions: Biological: BCG, NeisVac‐C®, Pediacel®, Infanrix™, Prevenar‐13®, Menitorix®, Priorix®, Rotarix®;   Biological: NeisVac‐C®, Pediacel®, Infanrix™, Prevenar‐13®, Menitorix®, Priorix®, Rotarix®
Outcome Measure: MenC-specific IgG in blood
5 Not yet recruiting Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis
Condition: Infections, Rotavirus
Intervention: Procedure: Stool sample collection
Outcome Measures: Full vaccination status of Rotarix™ (2 doses) with the vaccine administered at least 2 weeks before hospitalisation in RV-positive SGE children (cases) compared to RV-negative SGE children (controls).;   Full/partial vaccination status (at least one dose of Rotarix™) with the vaccine administered at least 2 weeks before hospitalisation in RV-positive SGE children (cases) compared to RV-negative SGE children (controls).;   Occurrence of specific RV genotype among the enrolled RV SGE children with full/partial vaccination status (at least one dose of Rotarix™ with the vaccine is administered at least 2 weeks before hospitalisation).;   Occurrence of RV SGE in children by age at hospitalisation with full/partial vaccination status (at least one dose of Rotarix™ with the vaccine administered at least 2 weeks before hospitalisation).;   Occurrence of RV SGE in children by severity with assessment of severity of RV SGE cases by the Vesikari scale.;   Occurrence of SGE [≤14 days prior to admission/ Emergency Department (ED) stay] among all hospitalised children.;   Occurrence of RV SGE hospital admissions/ ED stays among children hospitalised at the study hospital(s) for SGE.;   Occurrence of RV SGE admissions/ ED stays by age of the child (at hospitalisation) and month of year.;   Occurrence of RV genotypes among children admitted to (or who have had an ED stay at) the study hospital(s) for SGE.
6 Recruiting Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants
Conditions: Poliomyelitis;   Diphtheria;   Haemophilus Influenzae Type b;   Tetanus;   Acellular Pertussis;   Hepatitis B
Interventions: Biological: Infanrix hexa;   Biological: Pediarix;   Biological: ActHIB;   Biological: Pentacel;   Biological: Engerix-B;   Biological: Infanrix;   Biological: Hiberix;   Biological: Prevnar13;   Biological: Rotarix
Outcome Measures: Evaluation of immunogenicity with respect to pertussis components of the study vaccines Infanrix hexa and Pediarix;   Evaluation of immunogenicity (other parameters) with respect to the pertussis component of the study vaccines Infanrix hexa, Pentacel and Pediarix;   Evaluation of immunogenicity (other parameters) with respect to the pertussis component of the study vaccine Pentacel;   Evaluation of immunogenicity with respect to the other components of the study vaccines Infanrix hexa, Pediarix, ActHIB, Pentacel and Engerix-B;   Occurrence of solicited local and general symptoms;   Occurrence of unsolicited adverse events;   Occurrence of specific adverse events;   Occurrence of Serious adverse events (SAEs);   Immunogenicity with respect to all study vaccines in terms of antibody concentration and titres;   Immunogenicity with respect to the study vaccine Pentacel;   Immunogenicity with respect to the study vaccine Infanrix;   Immunogenicity with respect to the study vaccines ActHIB and Hiberix;   Occurence of solicited local and general symptoms;   Occurence of unsolicited adverse events;   Occurence of specific adverse events;   Occurrence of SAEs
7 Not yet recruiting Immunogenicity and Safety Study of Two Different Formulations of Human Rotavirus Vaccine, Rotarix in Healthy Infants
Condition: Infections, Rotavirus
Interventions: Biological: Liquid Human Rotavirus Vaccine 444563;   Biological: Lyophilized Human Rotavirus Vaccine 444563
Outcome Measures: Anti-rotavirus antibody seroconversion rate.;   Anti-rotavirus antibody concentrations in terms of Geometric Mean Concentrations (GMCs).;   Occurrence of solicited adverse events.;   Occurrence of unsolicited adverse events.;   Occurrence of serious adverse events.;   Presence of wild type rotavirus (RV) in gastroenteritis (GE) stool samples.
8 Unknown  Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure
Conditions: Intestinal Failure;   Rotavirus Vaccines
Intervention: Biological: Rotarix
Outcome Measures: The safety of the rotavirus vaccine in infants with intestinal failure is the primary outcome variable.;   The secondary outcome measure is the preliminary measurement of the immunogenicity of the rotavirus vaccine in infants with intestinal failure.
9 Recruiting Safety of P2-VP8 in South African Toddlers and Infants
Condition: Rotavirus
Interventions: Biological: P2-VP8 subunit rotavirus vaccine;   Other: Placebo
Outcome Measures: Safety • Number of SAEs • Number of AEs • Number of vaccine induced local and systemic reactions Occurrence of Serious Adverse Events;   immunogenicity
10 Recruiting Phase I/II Descending Age Study of P2VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers and Infants
Condition: Evaluation of a Rotavirus Vaccine
Interventions: Biological: P2VP8 Subunit Vaccine 10mcg;   Biological: P2VP8 Subunit Vaccine 30 mcg;   Biological: P2VP8 Subunit Vaccine 60mcg;   Biological: Placebo;   Biological: Cohort B2 P2VP8 D1;   Biological: Cohort B2 P2VP8 D2
Outcome Measures: number of vaccine induced reactions;   proportion of infants with anti-p2-vp8 IgG and IgA sero responses;   number of adverse events;   Neutralizing antibody GMT in infants before and after Rotarix vaccination
11 Not yet recruiting Hepatitis B Vaccination in Infants
Conditions: Meningococcal Disease;   Pneumococcal Disease;   Haemophilus Influenzae Serotype b Disease;   Diphtheria, Tetanus and Pertussis;   Hepatitis b
Interventions: Biological: Menjugate;   Biological: Menitorix;   Biological: NeisVac-C
Outcome Measures: Proportions of infants achieving Hib IgG concentrations ≥0.15 µg/ml at one month after primary immunisation;   Proportion of infants achieving MenC SBA titres ≥8 at 4 months of age (one month after a single dose of a MenC-containing vaccine);   Proportions of infants achieving Hib IgG concentrations ≥1.00 µg/ml at one month after primary immunisation;   Proportion of infants achieving MenC SBA titres ≥128 at 4 months of age (one month after a single dose of a MenC-containing vaccine);   Hib IgG GMCs at one month after primary immunisation schedule;   MenC SBA GMT at 4 months of age (one month after a single dose of a MenC-containing vaccine);   Proportions of infants achieving Hib IgG concentrations ≥0.15 µg/ml at one month after routine 12-month booster vaccinations;   Proportions of infants achieving MenC SBA titres >8 at one month after routine 12-month booster vaccinations;   Proportions of infants achieving Hib IgG concentrations ≥1.00 µg/ml at one month after routine 12-month booster vaccinations;   Proportions of infants achieving MenC SBA titres >128 at one month after routine 12-month booster vaccinations;   Hib IgG GMC at one month after routine 12-month booster vaccinations;   MenC SBA GMT at one month after routine 12-month booster vaccinations
12 Recruiting Vaccine Effectiveness of RV1 in a Naïve Population
Conditions: Rotavirus Infections;   Gastroenteritis;   Diarrhea
Intervention:
Outcome Measure: ED visit or admission for RV+ sample
13 Recruiting Causes of Rotavirus Vaccine Failure in Zambian Children
Condition: Diarrhoea
Intervention:
Outcome Measures: Proportion of immunized infants exposed to high breast milk anti-rotavirus immunoglobulin-A who fail to seroconvert;   Proportion of immunized infants exposed to transplacentally-acquired, rotavirus-specific, infant serum IgG who fail to sero-convert.;   Proportion of immunized infants exposed to maternal HIV infection who fail to seroconvert;   Proportion of immunized infants with low micronutrient levels (as indicated by serum zinc and vitamin A), who fail to seroconvert
14 Recruiting Efficacy of Ondansetron on Vomiting Due to Acute Gastroenteritis in Pediatric During Winter
Conditions: Vomiting;   Gastroenteritis
Intervention: Drug: Ondansetron
Outcome Measures: Success will be defined by the absence of vomiting between 15 minutes and 4 hours after administration of study treatment.;   Hospital admissions for acute gastroenteritis, intravenous infusion for rehydration, return emergency department visit, severity and duration of diarrhea and vomiting. Treatment safety will also be assessed. These criteria will be assessed within 7 days

These studies may lead to new treatments and are adding insight into Rotarix etiology and treatment.

A major focus of Rotarix research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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