The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.

Condition	Intervention	Phase
Prophylaxis rotavirus	Vaccine: Rotavirus (vaccine)	Phase III

Further Study Details: 

Primary Outcomes: Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until 1 year old.
Secondary Outcomes: Occurrence of severe RV GE caused by the wild RV strain of serotype G1, non-G1 serotypes and due to each non-G1 serotypes during the period starting from 2 weeks after Dose 2 until 1 year old.; Occurrence of severe RV GE caused by the circulating wild 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 from Dose 1 until 1 year old.• Ser; • Immune response to EPI vaccinations at one to 2 months after the3rd dose of routine EPI vaccinations (at Visit 4).; In a subset of 400 subjects enrolled in year 2005:; • Immune response to OPV at one month after each dose of routine EPI vaccinations (at Visits 2, 4 and 6)."
Expected Total Enrollment:  6360

The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country.

Ages Eligible for Study:  6 Weeks   -   12 Weeks,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion criteria: Healthy infants 6 -12 weeks of age at the time of the first study vaccination whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). 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. (Topical steroids are allowed.); 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; 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00139347

Clinical Coordinator      +1.877.379.37.18 

Argentina
      Buenos Aires,  Argentina; Recruiting

Study chairs or principal investigators

Clinical Trials,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  444563/024
Last Updated:  August 30, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00139347
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
ClinicalTrials.gov processed this record on 2005-09-06