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Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months
This study has been completed.
First Received: October 6, 2006   No Changes Posted
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00385320
  Purpose

The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.


Condition Intervention Phase
Rotavirus Gastroenteritis
Biological: HRV vaccine
Phase II

MedlinePlus related topics: Gastroenteritis
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: To Assess the Efficacy, Immuno & Safety of 2 Doses of GSK HRV Vaccine at Different Virus Concentrations in Healthy Infants Aged 2 Months & Previously Uninfected With HRV, Concurrently Given With DTPw-HBV, Hib.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of RV GE

Secondary Outcome Measures:
  • Serum RV IgA antibody titre, Viral shedding, Seroprotection/seropositivity status for DTPwHBVHib antigens, Solicited, unsolicited & SAE

Estimated Enrollment: 2640
  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 or a birth weight of >2000g.
  • Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

  • Planned administration of oral polio vaccine during the period starting from 2 weeks before each dose of study vaccine(s) and ending 2 weeks after.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
  • History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B.
  • Previous vaccination against diphtheria, tetanus, pertussis, and/or Haemophilus influenzae type b.
  • History of allergic disease
  • 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.
  • Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination)
  • Previous confirmed occurrence of RV GE.
  • Household contact with an immunosuppressed individual or pregnant women.
  • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385320

Locations
Brazil, Pará
GSK Clinical Trials Call Center
Belém, Pará, Brazil
Mexico
GSK Clinical Trials Call Center
Tlalpan, Mexico
Venezuela
GSK Clinical Trials Call Center
Valencia, Venezuela
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: 444563/006
Study First Received: October 6, 2006
Last Updated: October 6, 2006
ClinicalTrials.gov Identifier: NCT00385320     History of Changes
Health Authority: Brazil: National Health Surveillance Agency

Study placed in the following topic categories:
Virus Diseases
Digestive System Diseases
Gastrointestinal Diseases
Healthy
Gastroenteritis

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on May 06, 2009