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

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01511133

First received: December 1, 2011

Last updated: January 26, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 1, 2011

Last Updated Date

January 26, 2012

Start Date ^ICMJE

April 2010

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01511133 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Serum and stool samples

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

Condition ^ICMJE

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

Intervention ^ICMJE

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.

Study Group/Cohort (s)

HRV Group
Subjects received two or three doses of HRV in previous studies.
Interventions:
- Procedure: Stool sample
- Procedure: Serum sample
Placebo Group
Subjects received two or three doses of placebo in previous studies.
Interventions:
- Procedure: Stool sample
- Procedure: Serum sample

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2010

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Weeks to 12 Weeks

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01511133

Other Study ID Numbers ^ICMJE

114444, 444563/022, 444563/033, 103477, 104480

Has Data Monitoring Committee

Not Provided

Responsible Party

Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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