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Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030.

This study has been completed.
Study NCT00329745.   Last updated on October 30, 2008.   Information provided by GlaxoSmithKline

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030.
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.
Brief Summary

This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of life in infants previously vaccinated with HRV vaccine or placebo in the following schedules:

at 3 and 4 months of age in study rota-028; at 2 and 4 months of age in study rota-029 or rota-030.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description

Note that no new subjects will be recruited in this extension phase studies.

The expected total enrolment for the primary studies was as follows:

rota-028: 5700 rota-029: 3018 rota-030: 1102
Study Phase Phase III
Study Type † Interventional
Study Design † Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
Primary Outcome Measure † Occurrence of severe RV GE caused by the wild RV strains [ Time Frame: During the period starting from 2 weeks after Dose 2 until two years of age ] [ Designated as safety issue: Yes ]
Occurrence of definite Intussusception (IS) cases [ Time Frame: Within 31 days after each vaccination ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure † Occurrence of severe RV GE caused by the wild RV strain of serotype G1 [ Time Frame: During the period starting from 2 weeks after Dose 2 until two years of age ] [ Designated as safety issue: Yes ]
Occurrence of severe RV GE due to non-G1 serotypes [ Time Frame: During the period starting from 2 weeks after Dose 2 until two years of age ] [ Designated as safety issue: Yes ]
Occurrence of severe RV GE due to each non-G1 serotype [ Time Frame: During the period starting from 2 weeks after Dose 2 until two years of age. ] [ Designated as safety issue: Yes ]
Occurrence of severe RV GE caused by the circulating wild-type RV strains, of severe RV GE caused by the wild RV strain of serotype G1, of severe RV GE due to non-G1 serotypes and of severe RV GE due to each non-G1 serotype [ Time Frame: From Dose 1 ] [ Designated as safety issue: Yes ]
Occurrence of RV GE caused by the circulating wild-type RV strains and requiring hospitalization and/or re-hydration in a medical facility [ Time Frame: During the period starting from 2 weeks after Dose 2 until two years of age. ] [ Designated as safety issue: Yes ]
Occurrence of severe RV GE caused by the circulating wild-type RV strains [ Time Frame: From one year of age up to two years of age ] [ Designated as safety issue: Yes ]
Occurrence of severe RV GE caused by the circulating wild-type RV strains [ Time Frame: During the period starting from 2 weeks after Dose 2 until one year of age ] [ Designated as safety issue: Yes ]
Occurrence of severe GE [ Time Frame: After Dose 2 until two years of age ] [ Designated as safety issue: Yes ]
Occurrence of severe RV GE caused by the wild RV strains [ Time Frame: During the period starting from 2 weeks after Dose 2 until three years of age ] [ Designated as safety issue: Yes ]
Occurrence of severe RV GE caused by the wild RV strain of serotype G1. [ Time Frame: During the period starting from 2 weeks after Dose 2 until three years of age ] [ Designated as safety issue: Yes ]
Occurrence of severe RV GE due to non-G1 serotypes [ Time Frame: During the period starting from 2 weeks after Dose 2 until three years of age ] [ Designated as safety issue: Yes ]
Occurrence of severe RV GE due to each non-G1 serotype [ Time Frame: During the period starting from 2 weeks after Dose 2 until three years of age. ] [ Designated as safety issue: Yes ]
Occurrence of RV GE caused by the circulating wild-type RV strains and requiring hospitalization and/or re-hydration therapy in a medical facility [ Time Frame: During the period starting from 2 weeks after Dose 2 until three years of age ] [ Designated as safety issue: Yes ]
Occurrence of severe RV GE caused by the circulating wild-type RV strains [ Time Frame: From two years of age up to three years of age ] [ Designated as safety issue: Yes ]
Occurrence of severe GE [ Time Frame: During the period starting from two weeks after Dose 2 until three years of age ] [ Designated as safety issue: Yes ]
For all subjects, occurrence of serious adverse events (SAEs) [ Time Frame: From Dose 1 until Visit 5 ] [ Designated as safety issue: Yes ]
For all subjects, occurrence of definite IS . [ Time Frame: During the period starting from Dose 1 until two years of age ] [ Designated as safety issue: Yes ]
For all subjects, occurrence of mortality [ Time Frame: Up to the age of 2 years ] [ Designated as safety issue: Yes ]
Serum rotavirus IgA antibody titres in all subjects in a subset of 100 subjects per country [ Time Frame: At visits 1 and 3 ] [ Designated as safety issue: No ]
Condition † Rotavirus Gastroenteritis
Intervention † Biological: Placebo
Biological: RotarixTM
MEDLINE PMIDs
Links Reference to the Primary Study NCT number This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status † Completed
Enrollment † 8687
Start Date † January 2007
Completion Date July 2008
Eligibility Criteria †

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 6 and 12 weeks of age in Hong Kong and Taiwan or 11 to 17 weeks of age in Singapore at the time of the first vaccination according to the country recommendations for the routine vaccination schedules.
  • Written informed consent obtained from the parent or guardian of the subject, prior any study procedure.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.

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.
  • 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. Oral intake of immunoglobulins is allowed.
  • 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.
Gender Both
Ages 2 Years to 3 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries † Singapore
Administrative Information Fields
NCT ID † NCT00329745
Organization ID 107070
Secondary IDs †† 107072, 107076
Study Sponsor † GlaxoSmithKline
Collaborators ††
Investigators †
Study Director:     GSK Clinical Trials     GlaxoSmithKline    
Information Provided By GlaxoSmithKline
Verification Date October 2008
First Received Date † May 24, 2006
Last Updated Date October 30, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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