Status:
COMPLETED
Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Rotavirus Infections
Gastroenteritis
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing the safety or imm...
Eligibility Criteria
Inclusion
- Infants in good health
Exclusion
- Previous administration of any oral poliovirus vaccine (OPV) and rotavirus vaccine
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
735 Patients enrolled
Trial Details
Trial ID
NCT00130832
Start Date
October 1 2005
End Date
July 1 2006
Last Update
April 1 2015
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