Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)
NCT ID: NCT00130832
Last Updated: 2015-04-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
735 participants
INTERVENTIONAL
2005-10-31
2006-07-31
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
TREATMENT
NONE
Study Groups
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1
RotaTeq and OPV concomitantly
Rotavirus Vaccine, Live, Oral, Pentavalent
Three doses of rotavirus vaccine, live, oral, pentavalent. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
Comparator: Oral Poliovirus Vaccine (OPV)
Three doses OPV. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
2
RotaTeq and OPV on staggered schedule
Rotavirus Vaccine, Live, Oral, Pentavalent
Three doses of rotavirus vaccine, live, oral, pentavalent. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
Comparator: Oral Poliovirus Vaccine (OPV) (staggered)
Three doses OPV. Dose 1 was given 14 to 28 days post Dose 1 of RotaTeq, Dose 2 was given 14 to 28 days post Dose 2 of RotaTeq, and Dose 3 was given 14 to 28 days post Dose 3 of RotaTeq.
Interventions
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Rotavirus Vaccine, Live, Oral, Pentavalent
Three doses of rotavirus vaccine, live, oral, pentavalent. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
Comparator: Oral Poliovirus Vaccine (OPV)
Three doses OPV. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
Comparator: Oral Poliovirus Vaccine (OPV) (staggered)
Three doses OPV. Dose 1 was given 14 to 28 days post Dose 1 of RotaTeq, Dose 2 was given 14 to 28 days post Dose 2 of RotaTeq, and Dose 3 was given 14 to 28 days post Dose 3 of RotaTeq.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Receipt of inactivated poliovirus vaccine (IPV) prior to the first dose of either study vaccine, or at any time during the course of the study
* Any condition resulting in depressed immunity
* Any allergy to any vaccine component as stated in the package circulars
* Allergies to polymyxin B, neomycin or any other antibiotics
* Receipt of intramuscular, oral, or intravenous corticosteroid treatment
* History of congenital abdominal disorders, intussusception, or abdominal surgery; clinical evidence of active gastrointestinal illness
* History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive
* Prior receipt of a blood transfusion or blood products, including immunoglobulin
* Fever, with a rectal temperature of ≥38.1°C (≥ 100.5°F) at the time of immunization
* Infants residing in a household with an immunocompromised person
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
References
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Ciarlet M, Sani-Grosso R, Yuan G, Liu GF, Heaton PM, Gottesdiener KM, Arredondo JL, Schodel F. Concomitant use of the oral pentavalent human-bovine reassortant rotavirus vaccine and oral poliovirus vaccine. Pediatr Infect Dis J. 2008 Oct;27(10):874-80. doi: 10.1097/INF.0b013e3181782780.
Other Identifiers
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2005_030
Identifier Type: -
Identifier Source: secondary_id
V260-014
Identifier Type: -
Identifier Source: org_study_id
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