Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00329745
Recruitment Status : Completed
First Posted : May 25, 2006
Results First Posted : October 14, 2009
Last Update Posted : December 9, 2016
Information provided by (Responsible Party):

May 24, 2006
May 25, 2006
July 2, 2009
October 14, 2009
December 9, 2016
January 2007
July 2008   (Final data collection date for primary outcome measure)
Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains [ Time Frame: From Year 2 up to Year 3 ]

Severe RV GE is an episode of severe GE in which rotavirus other than vaccine strain was identified in a GE stool sample.

Note that this outcome measure is secondary in the study protocol. We have reported it here as primary outcome measure, since none of the primary outcome measures in the study protocol pertain to the time point (Year 3 follow-up) presented in this summary.

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Complete list of historical versions of study NCT00329745 on Archive Site
Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: From the end of the primary study up to Year 3 ]
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Vaccine efficacy against severe RV GE caused by wild-type RV until 3 years of age
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Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)
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.

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 human rotavirus (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.

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

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Infections, Rotavirus
  • Biological: Rotarix™
    Oral administration, 2 doses
  • Biological: Placebo
    Oral administration, 2 doses
  • Experimental: Rotarix Group
    During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
    Intervention: Biological: Rotarix™
  • Placebo Comparator: Placebo Group
    During the primary study (NCT00197210) subjects received two oral doses of placebo.
    Intervention: Biological: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2008
July 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
2 Years to 3 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
107072 ( Other Identifier: GSK )
107076 ( Other Identifier: GSK )
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Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through following the timelines and process described on this site.
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Study Director: GSK Clinical Trials GlaxoSmithKline
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP