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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT00140673 |
Date of registration:
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31/08/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.
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Scientific title:
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A Placebo-controlled, Multi-country & Multi-center Study to Assess the Efficacy, Safety & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants |
Date of first enrolment:
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August 5, 2003 |
Target sample size:
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63227 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00140673 |
Study type:
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Interventional |
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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Argentina
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Brazil
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Chile
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Colombia
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Dominican Republic
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Finland
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Honduras
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Mexico
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Nicaragua
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Panama
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Peru
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Venezuela
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Contacts
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Name:
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GSK Clinical Trials |
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 6-13 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
Age minimum:
6 Weeks
Age maximum:
13 Weeks
Gender:
All
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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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1. Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until one year of age. 2. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.
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Secondary Outcome(s)
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Severe RV GE by wild-type G1, non-G1, each non-G1, 11 score after Dose 2 and Dose 1 until 1-year old.
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Definite IS until 1-year old and 2-years old.
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Severe RV GE in subset during the 2nd year and both years.
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Serum anti-RV IgA at Visits 1 and 3 (subset/country except Finland).
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SAEs.
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Secondary ID(s)
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444563/023
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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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