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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00425737
First received: January 22, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted

January 22, 2007
January 22, 2007
August 2000
Not Provided
Occurrence of RV GE
Same as current
No Changes Posted
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
Not Provided
 
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Rotavirus Gastroenteritis
Biological: Rotarix
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
405
December 2002
Not Provided

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.
Both
6 Weeks to 12 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00425737
444563/004
Not Provided
Not Provided
GlaxoSmithKline
Not Provided
Study Director: Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2007

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