Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™

Study Overview
=================
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.

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 GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus Vaccine (444563)

Conditions
-----------------
Rotavirus Infection, Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants

Intervention / Treatment
-----------------
* Procedure: Stool sample
* Procedure: Serum sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subjects enrolled previously in randomized, double-blind and placebo-controlled studies 444563/022 (NCT00263666), 444563/033 (NCT00757770), 103477 (NCT00169455), and 104480 (NCT00137930); Infants aged 6 to 12 weeks at Dose 1 vaccinated with either HRV vaccine or placebo; Infants for whom sufficient residual volume of the stool samples at predetermined time points is available; Infants for whom sufficient residual volume of the pre and post vaccination blood samples is available. Exclusion criteria: - Not applicable

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HRV Group<br>Subjects received two or three doses of HRV in previous studies. | Procedure: Stool sample<br>* 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.<br>Procedure: Serum sample<br>* Serum samples collected at pre and post vaccination time points in previous studies will be assessed for Anti-PCV-1 antibody.<br>|
| Placebo Group<br>Subjects received two or three doses of placebo in previous studies. | Procedure: Stool sample<br>* 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.<br>Procedure: Serum sample<br>* Serum samples collected at pre and post vaccination time points in previous studies will be assessed for Anti-PCV-1 antibody.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laboratory evaluations, infants, Porcine circovirus type 1 (PCV-1), serologic response, human rotavirus (HRV) vaccine