Rotavirus Efficacy and Safety Trial (REST)(V260-006)

Phase 3

Completed

• Conditions: Rotavirus Infections
• Interventions: Biological: Rotateq™

• Registration Number: NCT00090233
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Study First Submitted: 2004-08-25
• Study First Submitted QC: 2004-08-26
• Study First Posted: 2004-08-27
• Primary Completion: 2004-10
• Study Completion: 2004-10
• Results First Submitted: 2009-06-29
• Results First Submitted QC: 2011-04-06
• Results First Posted: 2011-05-05
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-18
• Last Update Posted: 2015-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69274

Inclusion Criteria

• Healthy infants

Exclusion Criteria

• None Specified

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Rotateq™	RotaTeq

Primary Outcome Measures

Name	Time	Method
Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination	At least 14 days following the 3rd vaccination through the first full rotavirus season	Rotavirus gastroenteritis cases consist of all participants with one or more episodes classified as positive. Multiple positive episodes for one participant are counted as a single case.
Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo	Within 42 days following any dose of RotaTeq™/placebo	Number of participants with confirmed intussusception within 42 days after each vaccination with RotaTeq™/placebo.

Secondary Outcome Measures

Name	Time	Method
G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus	14 days following the 3rd vaccination	Number of participants with a 3-fold rise or greater in G1 Serum neutralizing antibody (SNA) responses against rotavirus from baseline to postdose 3.
Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4	At least 14 days following the 3rd vaccination	Health Outcomes Substudy - Occurrence of hospital admissions and emergency department visits for episode(s) of rotavirus gastroenteritis associated with serotypes G1, G2, G3, or G4 by treatment group. Occurrence was expressed as the annual number of events per 1000 person-years.
Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose.	At least 14 days following the 3rd vaccination through the first rotavirus season	Number of participants with rotavirus gastroenteritis whose clinical score was \>8 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms \[range: total score 0 (best) to 24 (worst)\].
Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose	At least 14 days following the 3rd vaccination through the first rotavirus season	Number of participants with rotavirus gastroenteritis whose clinical score was \>16 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms \[range: total score 0 (best) to 24 (worst)\].
Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo	42 days following third dose	The number of participants who achieved seroprotection/seroconversion to hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, \& polio types 1, 2, \& 3, per established criteria.
Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin	42 days following third dose	Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin. Antibody titers were measured with an indirect, non-competitive, enzyme immunoassay (EIA).
Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F	42 days following third dose	Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. Serum antibody titers to type-specific pneumococcal polysaccharides were determined by an EIA.