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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01511133

Enrollment

Registered

2012-01-18

Start date

2010-04-30

Completion date

2010-06-30

Last updated

2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Laboratory evaluations, infants, Porcine circovirus type 1 (PCV-1), serologic response, human rotavirus (HRV) vaccine

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.

Interventions

PROCEDUREStool 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.

PROCEDURESerum sample

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

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Weeks to 12 Weeks

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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)
Presence of serum anti-PCV-1 antibody	At pre and post vaccination time points (At Day 0 and 2 Months after last dose vaccination)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026