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

Completed

• Conditions: Infections, Rotavirus
• Interventions: Procedure: Serum sample

• Registration Number: NCT02153333
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-29
• Study First Posted: 2014-06-03
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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.

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Exclusion Criteria

• Not Applicable

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HRV Group	Serum sample	Subjects who had received 2 doses of HRV vaccine in previous studies.
Placebo Group	Serum sample	Subjects who had received 2 doses of placebo in previous studies.

Primary Outcome Measures

Name	Time	Method
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.