Clinical Trial Search

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

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

Primary: Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) — 99; 109 Participants — p=0.4

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

Primary: Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody — 246; 255; 2; 3 Participants

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

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

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

Primary: Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies — 171; 173; 56; 60 Participants

Primary: Geometric Mean Concentration (GMC) of Serum Anti-rotavirus Immunoglobulin A (IgA) Antibodies 28 Days After Second Vaccination — 48.25; 35.04 U/mL

Primary: Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) — 4; 3 Subjects — p=0.691

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

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

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: The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA — 82.35 Percentage of…

Primary: Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value — 456; 456; 456 Participants

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…

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

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

Primary: Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] — 167.9; 193.2; 171.0; 9.3 dilution units — p=<0.001

Primary: Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV — 98.9; 100.0; 98.3; 99.5…

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