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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014