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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01511133 |
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Date of registration:
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01/12/2011 |
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Primary sponsor: |
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Public title:
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Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™
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Scientific title:
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Blinded Retrospective Laboratory Evaluations to Assess the Serologic Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in the Stool of Infants Aged 6 to 12 Weeks Following Administration of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus Vaccine (444563) |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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1 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01511133 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Retrospective
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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:
- Subjects enrolled previously in randomized, double-blind and placebo-controlled
studies 444563/022 (NCT00263666), 444563/033 (NCT00757770), 103477 (NCT00169455), and
104480 (NCT00137930);
- Infants aged 6 to 12 weeks at Dose 1 vaccinated with either HRV vaccine or placebo;
- Infants for whom sufficient residual volume of the stool samples at predetermined
time points is available;
- Infants for whom sufficient residual volume of the pre and post vaccination blood
samples is available.
Exclusion criteria:
- Not applicable
Age minimum:
6 Weeks
Age maximum:
12 Weeks
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants
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Rotavirus Infection
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Intervention(s)
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Procedure: Serum sample
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Procedure: Stool sample
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Primary Outcome(s)
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Presence of PCV-1 DNA and pattern of detection in the stool samples collected
[Time Frame: At pre-defined time points after vaccination (3-7 time points up to day 45 after vaccination)]
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Presence of serum anti-PCV-1 antibody
[Time Frame: At pre and post vaccination time points (At Day 0 and 2 Months after last dose vaccination)]
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Secondary ID(s)
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103477
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104480
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114444
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444563/022
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444563/033
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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