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

May 15, 2017 updated by: GlaxoSmithKline

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Serum and stool samples collected from 4 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.

Study Type

Observational

Enrollment (Actual)

1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Infants aged 6 to 12 weeks from 4 previously conducted clinical trials, who received 2 or 3 doses of either Rotarix™ or Placebo

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of PCV-1 DNA and pattern of detection in the stool samples collected
Time Frame: At pre-defined time points after vaccination (3-7 time points up to day 45 after vaccination)
At pre-defined time points after vaccination (3-7 time points up to day 45 after vaccination)
Presence of serum anti-PCV-1 antibody
Time Frame: At pre and post vaccination time points (At Day 0 and 2 Months after last dose vaccination)
At pre and post vaccination time points (At Day 0 and 2 Months after last dose vaccination)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

December 1, 2011

First Submitted That Met QC Criteria

January 12, 2012

First Posted (Estimate)

January 18, 2012

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114444
  • 103477 (Other Identifier: GSK)
  • 444563/022 (Other Identifier: GSK)
  • 104480 (Other Identifier: GSK)
  • 444563/033 (GSK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rotavirus Infection

Clinical Trials on Stool sample

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe