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.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00429481
First received: January 30, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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
  Eligibility

Ages Eligible for Study:   11 Weeks to 17 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429481

Locations
Singapore
GSK Clinical Trials Call Center
Singapore, Singapore
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov 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
Gastroenteritis
Vomiting

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 15, 2014