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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-06-30

Brief Summary

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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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Detailed Description

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

Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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HRV Group

Subjects received two or three doses of HRV in previous studies.

Stool sample

Intervention Type 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

Intervention Type PROCEDURE

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.

Stool sample

Intervention Type 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

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Serum sample

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.