Clinical Trial Search

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

Primary: Percentage of Participants Developing New Grade >=3 Adverse Events — 1.6; 4.7; 13.5; 12.8 Percentage of participants — p=0.62

Primary: Number of Participants With Adverse Events. — 14; 12 participants

Primary: Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo — 6; 5 Participants — p=0.006

Primary: Estimating the Incidence of Rotavirus Gastroenteritis Associated Hospitalization in Children < 5 Years of Age — 428 Participants

Primary: Matched VE Participants — 26; 22; 16; 1 participants

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

Primary: Matched VE Participants in the Minimum Age Model — 31; 70; 6; 31 Participants

Primary: Safety and Tolerability of the Oral RotaTeq® Vaccine — 18; 3 Individual Adverse Events

Primary: Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine — 54; 40; 42; 37 Participants

Primary: Number of Participants With a Cumulative Anti Rotavirus Serum Immunoglobulin A (IgA) Response (≥3 Fold Increase From Baseline) in Neonatal Vaccine Schedule at High Mid…

Primary: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain — 30; 26; 56; 70 subjects

Primary: Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhea). — 147; 98; 212 Subjects

Primary: The Effects of RV1 and RV5 With or Without Other Routine Immunizations on Gastrointestinal Anatomy — 2; 1; 0; 1 Participants — p=0.2

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

Primary: Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains — 21; 75 Participants

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

Primary: Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination — 0; 0; 0; 0 Participants

Primary: Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A — 280; 5 subjects

Primary: Proportion of Immunized Infants Exposed to High Breast Milk Anti-rotavirus Immunoglobulin-A Who Fail to Seroconvert — 0.602 Proportion of exposed infants

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…

Primary: Number of Participants With Vaccine Induced Reactions — 3; 8; 4; 6 Participants

Primary: Number of Subjects Reporting Solicited General Symptoms — 204; 50; 405; 259 Participants

Primary: Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea) — 42 subjects

Primary: Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea — 26; 28 Participants

Primary: Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea — 78 subjects

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

Primary: Maximum Severity of Adverse Events After Any Vaccination — 1; 2; 0; 2 Participants — p=0.44

Primary: G1 Serum-neutralizing Antibody — 188; 184.5 titers

Primary: Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations — 90.25; 94.16 U/mL