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.
Primary Outcome Measures:
- 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 ]
- Occurrence of definite Intussusception (IS) cases [ Time Frame: Within 31 days after each vaccination ]
Secondary Outcome Measures:
- 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 ]
- 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 ]
- 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. ]
- 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 ]
- 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. ]
- 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 ]
- 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 ]
- Occurrence of severe GE [ Time Frame: After Dose 2 until two years of age ]
- 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 ]
- 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 ]
- 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 ]
- 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. ]
- 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 ]
- 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 ]
- Occurrence of severe GE [ Time Frame: During the period starting from two weeks after Dose 2 until three years of age ]
- For all subjects, occurrence of serious adverse events (SAEs) [ Time Frame: From Dose 1 until Visit 5 ]
- For all subjects, occurrence of definite IS . [ Time Frame: During the period starting from Dose 1 until two years of age ]
- For all subjects, occurrence of mortality [ Time Frame: Up to the age of 2 years ]
- Serum rotavirus IgA antibody titres in all subjects in a subset of 100 subjects per country [ Time Frame: At visits 1 and 3 ]
Enrollment: |
8685 |
Study Start Date: |
January 2007 |
Primary Completion Date: |
July 2008 (Final data collection date for primary outcome measure) |
Group A: Experimental
|
Biological: RotarixTM
Oral administration, 2 doses
|
Group B: Active Comparator
|
Biological: Placebo
Oral administration, 2 doses
|
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