A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)
NCT ID: NCT01003431
Last Updated: 2015-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2009-12-31
2010-09-30
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
NONE
Study Groups
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1
RotaTeq™ + DTwP
Rotavirus Vaccine, Live, Oral, Pentavalent
\[Intervention name: RotaTeq™ administered concomitantly with Tritanrix™ HepB (DTwP)\] Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration.
2
Rotarix™ + DTwP
Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP)
Two 1.0 mL oral doses of Rotarix™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration (the second administration will be Tritanrix™ HepB only).
3
RotaTeq™ + DTaP
Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)
Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of INFANRIX™ will be given at the same time with about 1 month between each administration.
Interventions
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Rotavirus Vaccine, Live, Oral, Pentavalent
\[Intervention name: RotaTeq™ administered concomitantly with Tritanrix™ HepB (DTwP)\] Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration.
Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP)
Two 1.0 mL oral doses of Rotarix™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration (the second administration will be Tritanrix™ HepB only).
Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)
Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of INFANRIX™ will be given at the same time with about 1 month between each administration.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Impaired immune system
* Prior administration of any rotavirus vaccine or DTwP/DTaP
* Fever of \>= 38.1C (100.5F) at the time of vaccination
* History of prior rotavirus infection, chronic diarrhea, or failure to thrive
* Evidence of active gastrointestinal illness
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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V260-036
Identifier Type: -
Identifier Source: secondary_id
V260-036
Identifier Type: -
Identifier Source: org_study_id
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