Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™
Completed
- Conditions
- Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated InfantsRotavirus Infection
- Registration Number
- NCT01511133
- Lead Sponsor
- GlaxoSmithKline
- 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 Description
Serum and stool samples collected from 4 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Presence of PCV-1 DNA and pattern of detection in the stool samples collected At pre-defined time points after vaccination (3-7 time points up to day 45 after vaccination) Presence of serum anti-PCV-1 antibody At pre and post vaccination time points (At Day 0 and 2 Months after last dose vaccination)
- Secondary Outcome Measures
Name Time Method