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

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:

MedlinePlus related topics: Bowel Movement Rotavirus Infections

Drug Information available for: Deoxyribonucleic acid Rotarix

U.S. FDA Resources

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

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 June 18, 2013