A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: August 31, 2005
Last updated: September 13, 2012
Last verified: September 2012
The main objectives of this study are: 1) In a subset (N = 20 000), to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age. 2) In all subjects (N = 60 000), 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
Rotavirus Infection
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, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Placebo-controlled, Multi-country & Multi-center Study to Assess the Efficacy, Safety & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 1. Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until one year of age. 2. 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, 11 score after Dose 2 and Dose 1 until 1-year old. [ Designated as safety issue: No ]
  • Severe RV GE in subset during the 2nd year and both years. [ Designated as safety issue: No ]
  • SAEs. [ Designated as safety issue: No ]
  • Definite IS until 1-year old and 2-years old. [ Designated as safety issue: No ]
  • Serum anti-RV IgA at Visits 1 and 3 (subset/country except Finland). [ Designated as safety issue: No ]

Enrollment: 63227
Study Start Date: August 2003
Study Completion Date: October 2005
Primary Completion Date: October 2005 (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 6-13 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country. A minimum 2-week interval was to be observed between HRV vaccine and OPV doses. Of the total enrolled cohort of 60 000 subjects, 20 000 subjects were followed for efficacy and safety until one year of age while 40 000 subjects were followed for safety only until 30-90 days after the second HRV/placebo dose. A subset (N = approximately 13 000) of the 20 000 subjects are followed for efficacy and safety until 24 months of age. From the 20 000 subjects followed for efficacy and safety, a subset of 100 subjects per country (center specific, except Finland) provided two blood sample to evaluate immunogenicity.

Ages Eligible for Study:   6 Weeks to 13 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

  • Healthy infants 6-13 weeks of age at the time of the first study vaccination whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits)

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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
  • Child is unlikely to remain in the study area for the duration of the 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
  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: NCT00140673

GSK Investigational Site
Villanueva, Mendoza, Argentina, 5521
GSK Investigational Site
Belem, Pará, Brazil, 66 090 000
GSK Investigational Site
Concepción, Región Del Biobio, Chile
GSK Investigational Site
Valparaiso, Valparaíso, Chile
GSK Investigational Site
Cali Colombia, Colombia
Dominican Republic
GSK Investigational Site
Santo Domingo, Dominican Republic
GSK Investigational Site
Tampere, Finland, 33014
GSK Investigational Site
Tegucigalpa, Honduras
GSK Investigational Site
Cuernavaca, Mexico
GSK Investigational Site
Durango, Mexico, 3400
GSK Investigational Site
Mexico DF, Mexico, 06720
GSK Investigational Site
Mexico, Mexico, 04530
GSK Investigational Site
Tlanepantla, Mexico, 54150
GSK Investigational Site
Leon, Nicaragua
GSK Investigational Site
Panama, Panama
GSK Investigational Site
Lima, Peru, Lima
GSK Investigational Site
Valencia, Carabobo, Venezuela
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

De Vos B et al. Rotarix™: an effective way to prevent rotavirus diarrhoea and vomiting. Proc. 9th Congress of the Asian Pan Pacific Society of Paediatric Gastroenterology, Hepatology and Nutrition & 27th Annual Congress of the Malaysian Paediatric Association, Kuala Lumpur, 16-19 June 2005.
Vesikari T et al. Overcoming the safety hurdle: the rotavirus vaccine RIX4414 is not associated with intussusception. 23rd Annual Meeting of European Society for Paediatric Infectious Diseases, Valencia, Spain, 18-20 May 2005.
Vesikari T et al. RIX4414: A new attenuated human rotavirus vaccine. 23rd Annual Meeting of European Society for Paediatric Infectious Diseases, Valencia, Spain, 18-20 May 2005.
Vesikari et al. High efficacy of two doses of Rotarix™ (RIX4414) against rotavirus disease in Europe, Latin-America and Asia. Presented at ACPID, Cebu, Philippines, 7-10 March 2006.
O'Ryan et al. A novel rotavirus vaccine RIX4414 is not associated with intussusception. Proc. 44th ICAAC, Washington DC, USA, October 30-November 2, 2004.
Costa Clemens SA et al. Operational organization of a large scale phase III clinical trial of rotavirus vaccine in multiple sites and countries in Latin America. Poster presented at ICP, Cancun, Mexico, 15-20 August 2004.
Macias M et al. The rotavirus vaccine RIX4414 (Rotarix) is not associated with intussusception in one year old infants. Proc. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), Washington DC, USA, 16-19 December 2005.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00140673     History of Changes
Other Study ID Numbers: 444563/023 
Study First Received: August 31, 2005
Last Updated: September 13, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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

ClinicalTrials.gov processed this record on August 22, 2016