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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 2023 |
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Main ID: |
NCT02145000 |
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Date of registration:
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20/05/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Niger
ROSE |
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Scientific title:
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Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis Among Infants in Niger |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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6586 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02145000 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Niger
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Contacts
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Name:
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Rebecca Grais, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Epicentre |
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Name:
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Sheila Isanaka, ScD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Epicentre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. aged 6-8 weeks at the time of inclusion
2. able to swallow and no history of vomiting within 24 hours
3. resident in Madarounfa Health District and within the catchment area of the central
health facility
4. intending to remain in the study area for 2 years
5. parent/guardian providing written informed consent
Exclusion Criteria:
Any of the following will exclude an infant from randomization in the study:
1. known history of congenital abdominal disorders, intussusception, or abdominal surgery
2. receipt of intramuscular, oral, or intravenous corticosteroid treatment within 2 wks
3. receipt or planned administration of a blood transfusion or blood products, including
immunoglobulins
4. any known immunodeficiency condition
5. any serious medical condition
6. any other condition in which, in the judgment of the investigator, would interfere
with or serves as a contraindication to protocol adherence or the parent/guardian's
ability to give informed consent
Age minimum:
6 Weeks
Age maximum:
2 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Severe Rotavirus Gastroenteritis
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Intervention(s)
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Biological: Placebo
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Biological: Rotavirus vaccine (BRV-PV)
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Primary Outcome(s)
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Laboratory-confirmed episode of severe rotavirus gastroenteritis
[Time Frame: From 28 days post-Dose 3 until 117 cases are accrued or when all participating infants reach 2 years of age if 117 cases are not attained]
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Secondary Outcome(s)
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Anti-rotavirus IgA geometric mean titres
[Time Frame: 28 days post-Dose 3]
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Anti-rotavirus IgA sero-response rate
[Time Frame: 28 days post-Dose 3]
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Laboratory-confirmed episode of rotavirus gastroenteritis with a Vesikari score of = 17
[Time Frame: From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age]
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Laboratory-confirmed episode of severe rotavirus gastroenteritis due to rotavirus serotypes G1, G2, G3, G4 and G9
[Time Frame: From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age]
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Serious adverse events
[Time Frame: From the time of Dose 1 until 2 years of age]
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Any adverse health event
[Time Frame: From the time of Dose 1 to 28 days post-Dose 3]
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Laboratory-confirmed episode of rotavirus gastroenteritis of any severity
[Time Frame: From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age]
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Episode of gastroenteritis of any cause
[Time Frame: From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age]
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Hospitalization of any cause
[Time Frame: From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age]
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Hospitalization due to laboratory-confirmed cases of rotavirus gastroenteritis of any cause
[Time Frame: From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age]
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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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