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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)
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.
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Status | COMPLETED |
| Enrolment | 1 |
| Start date | 2010-04 |
| Completion | 2010-06 |
Conditions
- Rotavirus Infection
- Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants
Interventions
- Stool sample
- Serum sample
Primary outcomes
- 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)