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Assessment of the Serologic Response to Porcine Circovirus Type 1 (PCV-1) in the Serum of Infants and Toddlers, Following Administration of IPV (Inactivated Poliovirus Vaccine)-Containing Vaccines

NCT ID: NCT01651247

Last Updated: 2012-07-27

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

2010-05-31

Study Completion Date

2010-05-31

Brief Summary

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This study aims to analyse the serologic response to PCV-1 in the PEDIARIX® \[GSK Biologicals' Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine\] and KINRIX® (GSK Biologicals' Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) vaccine products. The samples have been collected at pre-determined time points from a subset of subjects who participated in selected studies \[217744/085 and 213503/048\] conducted in the United States.

Detailed Description

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Serum samples from the previously conducted clinical trials (217744/085 and 213503/048) are used in this study.

Conditions

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Presence of Materials From PCV-1

Keywords

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Toddlers Retrospective Porcine circovirus type 1 (PCV-1) Infants Laboratory evaluations IPV

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Group A

Subjects received 3 doses of the combination DTaP-HepB-IPV vaccine or separately administered DTaP, HepB, and IPV vaccines at 2, 4, and 6 months of age, in a previous study (217744/085).

Serum sample

Intervention Type PROCEDURE

Serum samples collected at pre-determined time points in previously completed studies (217744/085 and 213503/048) will be analysed to detect the presence of anti PCV-1 antibodies.

Group B

Subjects received a single dose of the combination DTaP-IPV vaccine or separately administered DTaP and IPV vaccines at 4-6 years of age, in a previous study (213503/048).

Serum sample

Intervention Type PROCEDURE

Serum samples collected at pre-determined time points in previously completed studies (217744/085 and 213503/048) will be analysed to detect the presence of anti PCV-1 antibodies.

Interventions

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Serum sample

Serum samples collected at pre-determined time points in previously completed studies (217744/085 and 213503/048) will be analysed to detect the presence of anti PCV-1 antibodies.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subjects enrolled previously in randomized, open and multicentre studies \[217744/085; 213503/048\].
* Subjects aged 6 months to 6 years at last dose vaccinated with either DTaP-HepB-IPV vaccine or separately administered DTaP, HepB, and IPV vaccines or DTaP-IPV vaccine or separately administered DTaP and IPV vaccines.
* Subjects for whom sufficient residual volume of the pre and post vaccination blood samples is available.

Exclusion Criteria

* Not Applicable
Minimum Eligible Age

2 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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213503/048

Identifier Type: -

Identifier Source: secondary_id

217744/085

Identifier Type: -

Identifier Source: secondary_id

114535

Identifier Type: -

Identifier Source: org_study_id