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

GlaxoSmithKline1 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

Stool samplePROCEDURE

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 samplePROCEDURE

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

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 12 Weeks

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Data from ClinicalTrials.gov

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