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 immunogenicity of either vaccine.

Condition	Intervention	Phase
Rotavirus disease	Vaccine: An Investigational Vaccine	Phase III

Ages Eligible for Study:  6 Weeks   -   12 Weeks,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Infants in good health

Exclusion Criteria:

• 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 38.1C (100.5F) at the time of immunization
• Infants residing in a house hold with an immunocompromised person

Please refer to this study by ClinicalTrials.gov identifier  NCT00130832

Brazil, SP
      Merck Sharp & Dohme Farmaceutica Ltda., Sao Paulo,  SP,  04717-004,  Brazil
Costa Rica
      Merck Sharp & Dohme (I.A.) Corp., San Jose,  Costa Rica
Guatemala, City
      MSD Guatemala, Guatemala,  City,  1010,  Guatemala
Mexico, D.F.
      Merck Sharp & Dohme De Mexico, S.A. De C.V., Mexico,  D.F.,  1090,  Mexico

Study chairs or principal investigators

Medical Monitor,  Study Director,  Merck   

Study ID Numbers:  2005_030
Last Updated:  August 15, 2005
Record first received:  August 12, 2005
ClinicalTrials.gov Identifier:  NCT00130832
Health Authority: Brazil: National Health Suveillance Agency
ClinicalTrials.gov processed this record on 2005-08-23