Trials / Completed
CompletedNCT01511133
Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™
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)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 12 Weeks
- Healthy volunteers
- Not accepted
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.
Conditions
- Rotavirus Infection
- Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Stool sample | Stool samples collected at pre-determined time points in previous studies will be analysed to detect the presence of PCV-1 DNA and pattern of detection. |
| PROCEDURE | Serum sample | Serum samples collected at pre and post vaccination time points in previous studies will be assessed for Anti-PCV-1 antibody. |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2010-06-01
- Completion
- 2010-06-01
- First posted
- 2012-01-18
- Last updated
- 2017-05-16
Source: ClinicalTrials.gov record NCT01511133. Inclusion in this directory is not an endorsement.