Status:
COMPLETED
RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Meningitis, Meningococcal
Rotavirus Infections
Eligibility:
All Genders
42-55 years
Phase:
PHASE3
Brief Summary
Primary objective: To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine. The hypothesis tested is that the seroprote...
Eligibility Criteria
Inclusion
- Healthy infants, aged from 6 weeks through full 7 weeks,
- Consent form signed by at least one parent or by the legal representative properly informed about the study,
- Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.
Exclusion
- History of congenital abdominal disorders, congenital malformation of the gastrointestinal tract that could predispose to intussusception, or abdominal surgery,
- Congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency,
- Known or suspected impairment of immunological function,
- Known hypersensitivity to any component of RotaTeq® (e.g. sucrose) or of NeisVac-C® (including tetanus toxoid),
- Prior administration of any rotavirus vaccine,
- Prior administration of any vaccine within the 28 days prior to randomisation,
- Fever (rectal temperature ≥38.1°C) and/or acute diarrhoea and/or vomiting at randomisation,
- History of known prior rotavirus gastroenteritis, chronic diarrhoea, or failure to thrive,
- Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
- Clinical evidence of active gastrointestinal illness,
- Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 14 days prior to randomisation. Note: Infants on inhaled and/or topical steroids may participate in the study,
- Infants residing in a household with an immunocompromised person,
- Prior receipt of a blood transfusion or blood products, including immunoglobulins.
Key Trial Info
Start Date :
February 13 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2007
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT00443846
Start Date
February 13 2007
End Date
October 23 2007
Last Update
June 20 2018
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.