The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with DTacP without impairing the safety and immunogenicity of either vaccine

Condition	Intervention	Phase
Rotavirus Disease	Vaccine: V260, rotavirus vaccine, live, oral, pentavalent / Duration of Treatment 3-6 months  Drug: Comparator: DTacP/Duration of Treatment 3-6 mos	Phase III

Further study details as provided by Merck:

Primary Outcomes: Safety
Secondary Outcomes: Immunogenicity responses
Expected Total Enrollment:  522

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

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Infants in good health, 6 to 12 weeks of age

Exclusion Criteria:

• History of congenital abdominal disorders, intussusception, or abdominal surgery. Known or suspected impairment of immunological function. Known hypersensitivity to any component of the rotavirus vaccine. Prior administration of any rotavirus vaccine. Known hypersensitivity or contraindication to any component of the DTacP vaccine. Any infant born from a known HBsAg-positive mother. Prior adminstration of any oral polio vaccine. Receipt of one or more doses of inactivated poliovirus vaccine, diptheria, tetanus and acellular pertussis vaccine, diptheria, tetanus and pertussis vaccine, Haemophilus influenzae type b vaccine, or any hepatitis B vaccine prior to the first vaccination. Fever, with a rectal temperature greater than or equal to 38.1 degree C (greater than or equal to 100.5 degree F) at the time of immunization. History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive. Clinical evidence of active gastrointestinal illness. Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 2 weeks prior to vaccination. Infants residing in a household with an immunocompromised person. Prior receipt of a blood transfusion or blood products. History of seizure disorders or prior history of seizure disorders with or without fever.

Please refer to this study by ClinicalTrials.gov identifier  NCT00258154

Toll Free Number      1-888-577-8839 

Study chairs or principal investigators

Medical Monitor,  Study Director,  Merck   

Study ID Numbers:  2005_046; Immunogenicity responses
Last Updated:  December 2, 2005
Record first received:  November 15, 2005
ClinicalTrials.gov Identifier:  NCT00258154
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines
ClinicalTrials.gov processed this record on 2006-01-10