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

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

Official Title
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Safety and Efficacy of Pentavalent (G1, G2, G3, G4 , and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants

Conditions
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Rotavirus Infections

Intervention / Treatment
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* Biological: Rotateq™
* Biological: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy infants Exclusion Criteria: None Specified

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>RotaTeq | Biological: Rotateq™<br>* 3 doses of 2.0 mL RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.<br>* Other names: V260;|
| Placebo Comparator: 2<br>Placebo | Biological: Comparator: Placebo<br>* 3 doses of 2.0 mL Placebo to RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo | Number of participants with confirmed intussusception within 42 days after each vaccination with RotaTeq™/placebo. | Within 42 days following any dose of RotaTeq™/placebo | 
| Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination | 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. | At least 14 days following the 3rd vaccination through the first full rotavirus season | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus | Number of participants with a 3-fold rise or greater in G1 Serum neutralizing antibody (SNA) responses against rotavirus from baseline to postdose 3. | 14 days following the 3rd vaccination | 
| 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 | 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. | At least 14 days following the 3rd vaccination | 
| 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. | 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)]. | At least 14 days following the 3rd vaccination through the first rotavirus season | 
| 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 | 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)]. | At least 14 days following the 3rd vaccination through the first rotavirus season | 
| 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 | 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. | 42 days following third dose | 
| Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin | 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). | 42 days following third dose | 
| Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F | 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. | 42 days following third dose |