A phase II, double-blind, randomized, placebo controlled study to compare the immunogenicity, reactogenicity and safety of two different formulations of GlaxoSmithKline (GSK) Biologicals’ live attennuated human rotavirus (HRV) vaccine given as a two-dose primary vaccination in healthy infants previously uninfected with HRV - Rota-048

• Conditions: Immunization of healthy infants against HRV disease/illness.

• Registration Number: EUCTR2005-000449-12-FI
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

? Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
? A male or female between, and including, 6 and 12 weeks (42 – 90 days) of age at the time of the first vaccination.
? Written informed consent obtained from the parent or guardian of the subject.
? Healthy subjects as established by medical history and clinical examination before entering into the study.
? Born after a gestation period of 36 to 42 weeks inclusive.

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

Use of investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Planned administration of a vaccine not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
Concurrently participating in another clinical study
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition (determined by the investigator).
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
Major congenital defects/serious chronic illness.
Acute disease at time of enrolment.
GE within 7 days preceding the study vaccine administration
Contact with an immunosuppressed individual or pregnant women.
administration of immunoglobulins and/or blood products since birth or planned .
Previous confirmed occurrence of RV GE.
History of neurological disorders or seizures.

Study & Design

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