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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:
ClinicalTrials.gov Identifier:
NCT01511133
First Posted: January 18, 2012
Last Update Posted: May 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention
Rotavirus Infection Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants Procedure: Stool sample Procedure: Serum sample

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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) ]
  • 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) ]

Biospecimen Retention:   Samples With DNA
Serum and stool samples

Enrollment: 1
Study Start Date: April 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511133


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01511133     History of Changes
Other Study ID Numbers: 114444
444563/022 ( Other Identifier: GSK )
444563/033 ( Other Identifier: GSK )
103477 ( Other Identifier: GSK )
104480 ( Other Identifier: GSK )
First Submitted: December 1, 2011
First Posted: January 18, 2012
Last Update Posted: May 16, 2017
Last Verified: May 2017

Keywords provided by GlaxoSmithKline:
Laboratory evaluations
infants
Porcine circovirus type 1 (PCV-1)
serologic response
human rotavirus (HRV) vaccine

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases