Evaluation of Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq(TM)

• Conditions: Prevention of rotavirus gastroenteritis in infants and children caused by serotypes G1, G2, G3, G4, and G serotypes that contain P1A[8] (e.g., G9); Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-001611-23-SE
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-15
• Last Update Posted: 23 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 924

Inclusion Criteria

Healthy infants between ages of 6-12 weeks whose parent/guardian give written consent for study participation.
Are the trial subjects under 18? yes
Number of subjects for this age range: 924
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, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, abdominal surgery, intussusception; known or suspected impairment of immunological function, including Severe Combined Immunodeficiency (SCID); prior administration of any rotavirus vaccine; Clinical evidence of active gastrointestinal illness, with the exception of well-controlled gastroesophageal reflux disease (GERD); residing in a household with immunocompromised individual(s); Certain restrictions applied to receipt of investigational vaccines, systemic corticosteroids, and blood products; restrictions on other study participation.

Study & Design

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