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| 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. |
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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 † | 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 ] |
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| 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 ] |
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| Condition † | Rotavirus Gastroenteritis | ||||
| Intervention † | Biological: Placebo Biological: RotarixTM |
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| MEDLINE PMIDs | |||||
| Links | Reference to the Primary Study NCT number ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 8687 | ||||
| Start Date † | January 2007 | ||||
| Completion Date | July 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| 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 † |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | October 2008 | ||||
| First Received Date † | May 24, 2006 | ||||
| Last Updated Date | October 30, 2008 | ||||