To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: August 11, 2006
Last updated: November 21, 2012
Last verified: November 2012

August 11, 2006
November 21, 2012
September 2006
April 2007   (final data collection date for primary outcome measure)
  • Anti-RV IgA antibody SC at Month 4
  • Safety: solicited & unsolicited adverse events and SAEs
Same as current
Complete list of historical versions of study NCT00363545 on Archive Site
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To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)
A Study to Assess the Immunogenicity, Reactogenicity and Safety of 2 Different Formulations of GSK Bio Live Attenuated HRV Vaccine, Given as a Two-dose Primary Vaccination, in Healthy Infants Previously Uninfected With HRV
This trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of GSK Biologicals' HRV vaccine
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Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Biological: Lyophilized & Liquid formulation of HRV vaccine
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Velasquez AA et al. Immunogenicity of The Oral Live Attenuated Human Rotavirus Vaccine RIX4414 (Rotarix™) Oral Suspension (Liquid Formulation) Co-administered with Childhood Vaccinations in Panama. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks.
  • Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

  • se of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV/Hib and OPV vaccines within 14 days before each dose of HRV vaccine and ending 14 days after.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Household contact with an immunosuppressed individual or pregnant women.
  • Previous confirmed occurrence of RV GE.
6 Weeks to 12 Weeks
Contact information is only displayed when the study is recruiting subjects
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Study Director: GSK Clinical Trials GlaxoSmithKline
November 2012

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