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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 October 2016 |
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Main ID: |
NCT00139334 |
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Date of registration:
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30/08/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Test 2 Doses of the HRV Vaccine Given With or Without OPV in Healthy Infants in Bangladesh
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Scientific title:
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Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine (RIX4414 at 106.5 CCID50) When Given Concomitantly With OPV Versus Given Alone (HRV Vaccine Dose Given 15 Days After the OPV Dose) in Healthy Infants in Bangladesh |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00139334 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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Phase:
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Phase 2
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Healthy infants aged 6 weeks±1 at first study vaccination.
Exclusion criteria:
- Malnutrition, no history of rotavirus gastroenteritis, allergic disease or chronic
gastrointestinal disease, not received protocol-prohibited treatment.
Age minimum:
5 Weeks
Age maximum:
7 Weeks
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Infections, Rotavirus
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Intervention(s)
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Biological: Rotavirus
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Primary Outcome(s)
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Endpoints : Safety/immunogenicity.Immunogenicity of GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion at Visit 6 in the group receiving of HRV vaccine concomitantly with OPV versus placebo group.
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Secondary Outcome(s)
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Immunogenicity of GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion, vaccine take, and rotavirus shedding at Visit 6 in each group; Immunogenicity of OPV at Visit 6 in each group; Reactogenicity and safety in each group.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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