Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine in Healthy Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00425737
Recruitment Status : Completed
First Posted : January 23, 2007
Last Update Posted : September 16, 2016
Information provided by (Responsible Party):

January 22, 2007
January 23, 2007
September 16, 2016
August 2000
July 2001   (Final data collection date for primary outcome measure)
Occurrence of RV GE
Same as current
Complete list of historical versions of study NCT00425737 on Archive Site
Occurrence of severe RV GE, solicited symptoms (Day 0-14), unsolicited Adverse Events (Day 0-42), Serious Adverse Events (full study), presence of rotavirus antigen in stool samples, immunogenicity
Same as current
Not Provided
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Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine in Healthy Infants
A Study to Assess the Efficacy, Immunogenicity and Safety of Two Doses of Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotarix) in Healthy Infants.
To assess the efficacy, immune response and safety of the oral live attenuated HRV vaccine (Rotarix) in healthy infants approximately 2 months of age and previously uninfected with human rotavirus
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Infections, Rotavirus
Biological: Rotarix
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2001
July 2001   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy infants 6 and 12 weeks of age at the time of the first vaccination.
  • Written informed consent obtained from the parents or guardians of the subject.
  • Born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
  • Use of antibiotics during the period starting from 7 days before each dose of vaccine(s) and ending 7 days after.
  • Any clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
  • Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
  • Household contact with an immunosuppressed individual or pregnant woman.
  • Abnormal stool pattern.
  • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
  • Previous confirmed occurrence of rotavirus gastroenteritis.
Sexes Eligible for Study: All
6 Weeks to 12 Weeks   (Child)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through following the timelines and process described on this site.
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP