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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: January 30, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different concentrations) in healthy infants aged approximately 3 months previously uninfected with human rotavirus.

Condition Intervention Phase
Rotavirus Gastroenteritis
Biological: Rotarix
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Study to Assess the Efficacy, Immunogenicity and Safety of 2 Doses of Oral Live Attenuated Human Rotavirus Vaccine (Rotarix) at Different Viral Concentrations in Healthy Infants.

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of any RV GE

Secondary Outcome Measures:
  • Occurrence of severe RV GE, rotavirus IgA antibody titres, solicited symptoms (Day 0-15), unsolicited Adverse Events (D0-42), Serious Adverse Events (full study),

Estimated Enrollment: 2460
Study Start Date: December 2000

Ages Eligible for Study:   11 Weeks to 17 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy infants 11 and 17 weeks of age at the time of the first vaccination, born after a normal gestation period (between 36 and 42 weeks).
  • Written informed consent obtained from the parents or guardians of the subject.

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Previous vaccination against or history of or intercurrent diphtheria, tetanus, pertussis, polio and/or Hib.
  • 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 including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
  • History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
  • GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
  • Household contact with an immunosuppressed individual or pregnant woman.
  • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
  • Previous confirmed occurrence of RV GE.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00429481

GSK Clinical Trials Call Center
Singapore, Singapore
Sponsors and Collaborators
Study Director: Clinical Trials GlaxoSmithKline
  More Information Identifier: NCT00429481     History of Changes
Other Study ID Numbers: 444563/007 
Study First Received: January 30, 2007
Last Updated: January 30, 2007
Health Authority: Singapore: Health Sciences Authority

Keywords provided by GlaxoSmithKline:
Oral live attenuated human rotavirus vaccine

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on August 23, 2016