Status:
COMPLETED
V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Rotavirus Disease
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
The study is being conducted to demonstrate that the vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with INFANRIX(tm)hexa without impairing the safety and immuno...
Eligibility Criteria
Inclusion
- Healthy infant per investigator, 6 through 12 weeks of age
Exclusion
- 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 INFANRIX(tm) hexa
- Any infant born from a known HBsAg-positive mother
- Prior administration 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, or receipt of any vaccines with these antigens at any time during the course of the study
- 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
- Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study
- Any infant who cannot be adequately followed for safety by a contact visit
- History of seizure disorders or prior history followed for safety by a contact visit
- Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
403 Patients enrolled
Trial Details
Trial ID
NCT00258154
Start Date
February 1 2006
End Date
November 1 2006
Last Update
October 6 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.