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
- Interventions
- Procedure: Stool sampleProcedure: Serum sample
- 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
- Arm && Interventions
Group Intervention Description Placebo Group Stool sample Subjects received two or three doses of placebo in previous studies. HRV Group Stool sample Subjects received two or three doses of HRV in previous studies. Placebo Group Serum sample Subjects received two or three doses of placebo in previous studies. HRV Group Serum sample Subjects received two or three doses of HRV in previous studies.
- 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