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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 24, 2006 | ||||
| Last Updated Date | September 11, 2009 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Refer to the primary study (e-track: 444563/028/029/030 - NCT00197210) | ||||
| Change History | Complete list of historical versions of study NCT00329745 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: From the end of the primary study up to Year 3 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Vaccine efficacy against severe RV GE caused by wild-type RV until 3 years of age | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210) | ||||
| Official Title ICMJE | 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 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. |
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| 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 |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Rotavirus Gastroenteritis | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 8687 | ||||
| Completion Date | July 2008 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 2 Years to 3 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Singapore | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00329745 | ||||
| Responsible Party | Study Director, GSK | ||||
| Study ID Numbers ICMJE | 107070, 107072, 107076 | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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