Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following Administration of Rotarix™

Study Overview
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Brief Summary
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This study aims to evaluate the serologic response to PCV-1 in the serum samples previously collected during initiation of vaccination series of Human Rotavirus (HRV) vaccine studies (1-2 months post Dose 2 of HRV vaccine or placebo). Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.

Detailed Description
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Serum samples collected from 6 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.

Official Title
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Blinded Retrospective Laboratory Evaluations to Assess the Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following the Administration of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus Vaccine (444563)

Conditions
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Infections, Rotavirus

Intervention / Treatment
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* Procedure: Serum sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Not applicable as no subjects will be actively enrolled in this study, only the sera samples of the subjects who were a part of previously conducted trials will be used for testing. However, the archived serum samples of only those subjects who satisfy the following criteria will be included in this study: Subjects who received two doses of HRV vaccine or Placebo and were included in the ATP cohort for immunogenicity in the primary studies listed. Subjects for whom their parents or Legally Acceptable Representatives (LARs) had agreed that their child or wards blood samples could be used for further research while giving consent for any of the primary studies listed. Subjects who have sufficient residual volume of serum samples at both pre- and post-vaccination time points. Exclusion Criteria: Not Applicable

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HRV Group<br>Subjects who had received 2 doses of HRV vaccine in previous studies. | Procedure: Serum sample<br>* Serum samples collected at pre-vaccination and at 1-2 months post Dose 2 in the previously conducted clinical trials will be assessed for anti-PCV-1 antibodies in this study. Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.<br>|
| Placebo Group<br>Subjects who had received 2 doses of placebo in previous studies. | Procedure: Serum sample<br>* Serum samples collected at pre-vaccination and at 1-2 months post Dose 2 in the previously conducted clinical trials will be assessed for anti-PCV-1 antibodies in this study. Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seropositivity rates for anti-PCV-1 antibodies. |  | At 1-2 months post dose 2 of HRV vaccine or placebo. | 
| Seroconversion rates for anti-PCV-1 antibodies. |  | At 1-2 months post dose 2 of HRV vaccine or placebo. | 

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