N/A N=374 Vaccine Effectiveness of RV1 in a Naïve Population
Rotavirus Infections · Gastroenteritis · Diarrhea
Primary: Matched VE Participants — 26; 22; 16; 1 participants
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N/A N=362 Effectiveness of Monovalent Rotavirus Vaccine (RV1)
Rotavirus · Acute Gastroenteritis
Primary: Matched VE Participants in the Minimum Age Model — 31; 70; 6; 31 Participants
Phase 3 N=69,274 Rotavirus Efficacy and Safety Trial (REST)(V260-006)
Rotavirus Infections
Primary: Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo — 6; 5 Participants — p=0.006
Phase 2 N=202 Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers
HIV Infection · Rotavirus Infection
Primary: Percentage of Participants Developing New Grade >=3 Adverse Events — 1.6; 4.7; 13.5; 12.8 Percentage of participants — p=0.62
Phase 3 N=8,237 Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Given With Routine Childhood Vaccinations in Healthy African Infants
Infections, Rotavirus
Primary: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain — 30; 26; 56; 70 subjects
N/A N=3,111 Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants
Infections, Rotavirus
Primary: Number of Subjects Reporting Solicited General Symptoms — 204; 50; 405; 259 Participants
Phase 4 N=220 The Effects of Increased Inoculum on Oral Rotavirus Vaccine Take and Immunogenicity
Rotavirus Infection · Vaccine Response Impaired · Vaccine Virus Shedding
Primary: Number (or Percentage) of Infants in Each Study Arm Who Test Positive for Fecal Rotavirus Vaccine-strain Virus Shedding Post-vaccination — 63; 55 Participants
Phase 1 N=8 Safety and Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome
Short Bowel Syndrome
Primary: Safety and Tolerability of the Oral RotaTeq® Vaccine — 18; 3 Individual Adverse Events
Phase 4 N=456 Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana
Rotavirus Gastroenteritis
Primary: Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules — 28.9; 43.4 percentage of participants — p=0.014
Phase 3 N=7,504 Developing World Study for RotaTeq™ (V260-015)(COMPLETED)
Vomiting · Diarrhea · Fever
Primary: Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose — 79; 129; 38; 71 Subjects — p=<0.001
Phase 4 N=1,384 Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules
Rotavirus Infection
Primary: Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay — 186; 182; 175; 191 participants
N/A N=522 Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
Infections, Rotavirus
Primary: Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea — 78 subjects
Phase 1 N=80 Rotavirus Vaccine Produced by Butantan Institute
Rotavirus Infections
Primary: Number of Participants With Adverse Events. — 14; 12 participants
N/A N=1,439 To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
Infections, Rotavirus · Rotavirus Vaccines
Primary: Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhea). — 147; 98; 212 Subjects
Phase 3 N=1,312 Dose Confirmation Efficacy Study (V260-007)
Rotavirus Infections
Primary: Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose. — 15; 54…
N/A N=332 Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants
Infections, Rotavirus
Primary: Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea) — 42 subjects
Phase 4 N=66 An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)
Diarrhea · Gastroenteritis
Primary: G1 Serum-neutralizing Antibody — 188; 184.5 titers
Phase 4 N=620 Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
Immunity to Oral Rotavirus Vaccine · Immunity to Oral Polio Vaccine · Shedding of Oral Rotavirus Vaccine
Primary: Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine — 54; 40; 42; 37 Participants
Phase 3 N=1,600 Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
Infections, Rotavirus · Rotavirus Vaccines
Primary: Anti-Rota Virus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations in the Human Rotavirus (HRV) Liquid Formulation Groups (Liq_A, Liq_B and Liq_C) — 155.7; 147.3…
N/A N=390,659 Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States
Infections, Rotavirus
Primary: Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts — 0.021; 0.022; 0.021; 0.028 Incidences/Person-Month
Phase 3 N=3,333 Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants
Infections, Rotavirus
Primary: Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains — 21; 75 Participants
Phase 3 N=1,351 Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
Infections, Rotavirus
Primary: Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination — 139; 166; 41; 47 Participants
Phase 3 N=825 Phase III Study of Liquid Formulation of ROTAVIN
Diarrhea · Diarrhea Rotavirus
Primary: Geometric Mean Concentration (GMC) of Serum Anti-rotavirus Immunoglobulin A (IgA) Antibodies 28 Days After Second Vaccination — 48.25; 35.04 U/mL
Phase 3 N=449 Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants
Rotavirus
Primary: Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations — 90.25; 94.16 U/mL
Phase 4 N=101 Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study
Intussusception · Rotavirus Infections
Primary: The Effects of RV1 and RV5 With or Without Other Routine Immunizations on Gastrointestinal Anatomy — 2; 1; 0; 1 Participants — p=0.2
Phase 3 N=765 Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants
Infections, Rotavirus · Rotavirus Vaccines
Primary: Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains — 14; 34 subjects
N/A N=420 Causes of Rotavirus Vaccine Failure in Zambian Children
Diarrhoea
Primary: Proportion of Immunized Infants Exposed to High Breast Milk Anti-rotavirus Immunoglobulin-A Who Fail to Seroconvert — 0.602 Proportion of exposed infants
Phase 3 N=4,040 Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)
Rotavirus Gastroenteritis
Primary: Number of Participants With Any Severity of Rotavirus Gastroenteritis — 34; 109 Participants — p=<0.001
Phase 3 N=735 Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)
Rotavirus Infections · Gastroenteritis
Primary: Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3 — 888.0; 1139; 814.9; 814.5 Geometric Mean Titer (GMT) — p=<0.001
Phase 2 N=618 Safety and Immunogenicity Study of Trivalent P2-VP8 Subunit Rotavirus Vaccine in Adults, Toddlers and Infants
Healthy
Primary: Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination — 0; 0; 0; 0 Participants