Clinical Trials Directory

Trials / Completed

CompletedNCT02153333

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

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)

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 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

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

Conditions

Interventions

TypeNameDescription
PROCEDURESerum sampleSerum 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.

Timeline

Start date
2014-02-01
Primary completion
2014-12-01
Completion
2014-12-01
First posted
2014-06-03
Last updated
2015-04-06

Source: ClinicalTrials.gov record NCT02153333. Inclusion in this directory is not an endorsement.