Safety and Immunogenicity of Concomitant Use of RotaTeq™ and INFANRIX™ Hexa in Healthy Infants. - Concomitant Use of RotaTeq™ and HEXAVAC® in Healthy Childre

• Conditions: RotaTeq is an oral pentavalent vaccine indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, G4, and G-serotypes that contain P1 (e.g., G9).; MedDRA version: 10Level: LLTClassification code 10017913

• Registration Number: EUCTR2005-003508-12-BE
• Lead Sponsor: Merck Sharp & Dohme BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-19
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 522

Inclusion Criteria

Infants in good health, 6 to 12 weeks of age.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 INFANRIX™ hexa vaccine. 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, diphtheria, tetanus and acellular pertussis vaccine, diphtheria, 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/equal to 38.1 degrees C (great than/equal to 100.5 degrees 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified