Consistency Lots Vaccine Study (V260-009)

Study Overview
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Brief Summary
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This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.

Official Title
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Comparison of the Immunogenicity and Safety of Three Consistency Lots of V260 in Healthy Infants

Conditions
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Rotavirus Infections

Intervention / Treatment
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* Biological: rotavirus vaccine, live, oral, pentavalent
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy infants Exclusion Criteria: History of abdominal disorders from a birth defect, intussusception, or abdominal surgery Known or suspected problems with the immune system Fever at time of immunization Prior administration of a rotavirus vaccine History of known prior rotavirus disease, chronic diarrhea, or failure to thrive.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RotaTeq™ Lot 1<br> 8.81 X 10^7 IU/Dose of RotaTeq™ | Biological: rotavirus vaccine, live, oral, pentavalent<br>* Three oral doses ( 8.81 X 10^7 IU/Dose for Lot 1;  8.01 X 10^7 IU/Dose for Lot 2; and  6.91 X 10^7 IU/Dose for Lot 3) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination<br>* Other names: RotaTeq™;|
| Experimental: RotaTeq™ Lot 2<br> 8.01 X 10^7 IU/Dose of RotaTeq™ | Biological: rotavirus vaccine, live, oral, pentavalent<br>* Three oral doses ( 8.81 X 10^7 IU/Dose for Lot 1;  8.01 X 10^7 IU/Dose for Lot 2; and  6.91 X 10^7 IU/Dose for Lot 3) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination<br>* Other names: RotaTeq™;|
| Experimental: RotaTeq™ Lot 3<br> 6.91 X 10^7 IU/Dose of RotaTeq™ | Biological: rotavirus vaccine, live, oral, pentavalent<br>* Three oral doses ( 8.81 X 10^7 IU/Dose for Lot 1;  8.01 X 10^7 IU/Dose for Lot 2; and  6.91 X 10^7 IU/Dose for Lot 3) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination<br>* Other names: RotaTeq™;|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A[8] | 42 days following the 3rd vaccination |