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Completed

NCT Number: NCT01511133

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

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.

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Key information

Conditions

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

Age range

6 week–12 week

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stool sample

Procedure

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

Procedure

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

Primary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 18, 2012
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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