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
  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: 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) ] [ 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 ]

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

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511133

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01511133     History of Changes
Other Study ID Numbers: 114444, 444563/022, 444563/033, 103477, 104480
Study First Received: December 1, 2011
Last Updated: January 26, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014