Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
793 participants
INTERVENTIONAL
2003-05-31
2004-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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RotaTeq™ Lot 1
\~8.81 X 10\^7 IU/Dose of RotaTeq™
rotavirus vaccine, live, oral, pentavalent
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
RotaTeq™ Lot 2
\~8.01 X 10\^7 IU/Dose of RotaTeq™
rotavirus vaccine, live, oral, pentavalent
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
RotaTeq™ Lot 3
\~6.91 X 10\^7 IU/Dose of RotaTeq™
rotavirus vaccine, live, oral, pentavalent
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
Placebo
Placebo
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
Interventions
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rotavirus vaccine, live, oral, pentavalent
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
Placebo
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
6 Weeks
12 Weeks
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
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2004_078
Identifier Type: -
Identifier Source: secondary_id
V260-009
Identifier Type: -
Identifier Source: org_study_id
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