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

Rotavirus Infection Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511133
• Other study ID #: 114444
• Secondary ID: 444563/022444563
• Status: Completed
• Phase: N/A
• First received: December 1, 2011
• Last updated: May 15, 2017
• Start date: April 2010
• Est. completion date: June 2010

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Weeks to 12 Weeks

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• Serum sample
Serum samples collected at pre and post vaccination time points in previous studies will be assessed for Anti-PCV-1 antibody.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

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