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A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197210
First received: September 15, 2005
Last updated: October 2, 2014
Last verified: March 2012
  Purpose

The main objectives of this study are to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two years of age and to determine the safety of GSK Biologicals' HRV vaccine with respect to definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.


Condition Intervention Phase
Infections, Rotavirus
Biological: Rotavirus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-country and Multi-center Study to Assess the Efficacy and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of severe RV GE caused by the wild RV strains from 2 weeks after Dose 2 until two years of age. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severe RV GE by wild-type G1, non-G1, each non-G1 and severe GE from 2 weeks after Dose 1 and 2 until 2-year old. SAEs. Mortality. Definite IS until 2-years old. Serum anti-RV IgA at Visits 1 and 3 (100 subjects/country). [ Designated as safety issue: No ]

Enrollment: 10708
Study Start Date: December 2003
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Detailed Description:

The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age in Hongkong and Taiwan or 11-17 weeks of age in Singapore, according to a 0, 1 to 2-month schedule. Routine vaccinations are given concomitantly with the study vaccines at 2 or 3 and 4 months of age according to each local country regulation. Whenever OPV is used, a minimum 2-week interval should be observed between HRV vaccine and OPV doses.

  Eligibility

Ages Eligible for Study:   6 Weeks to 17 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy infants 6-12 or 11-17 weeks of age at the time of dose 1 whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol.

Exclusion criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • Child is unlikely to remain in the study area during study.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
  • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
  • Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
  • First or second degree of consanguinity of parents.
  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: NCT00197210

Locations
Singapore
GSK Investigational Site
Singapore, Singapore, 308433
GSK Investigational Site
Singapore, Singapore, 228510
GSK Investigational Site
Singapore, Singapore, 119074
GSK Investigational Site
Singapore, Singapore, 229899
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Phua KB et al. Human rotavirus vaccine RIX4414 (Rotarix™) is highly efficacious in Asian infants during the first three years of life. Abstract presented at the 13th Asian Pacific Congress of Pediatrics (APCP). Shanghai, China, 14-18 October 2009.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00197210     History of Changes
Other Study ID Numbers: 444563/028/029/030, 444563/029, 444563/030
Study First Received: September 15, 2005
Last Updated: October 2, 2014
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Rotavirus Infections
RNA Virus Infections
Reoviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014