Clinical Trial: Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: 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
Brief Summary: This study aims to test the clinical samples (stool and serum) previously collected during clinical development of HRV vaccine, to identify if there is any evidence of PCV-1 replication and/or immune response to the PCV-1 in vaccinated infants.
Detailed Summary: Serum and stool samples collected from 4 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.
Sponsor: GlaxoSmithKline
Current Primary Outcome:
- 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) ]
- 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) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: GlaxoSmithKline
Dates:
Date Received: December 1, 2011
Date Started: April 2010
Date Completion:
Last Updated: May 15, 2017
Last Verified: May 2017
