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Clinical Trials/NCT01651247
NCT01651247CompletedNot Applicable

Blinded Retrospective Laboratory Evaluations to Assess the Serologic Response to Porcine Circovirus Type 1 (PCV-1) in the Serum of Infants Aged 2 and 6 Months and Toddlers Aged 4-6 Years Following Administration of GlaxoSmithKline (GSK) Biologicals' IPV-containing Vaccines

GlaxoSmithKline0 sites1 target enrollmentStarted: May 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1
Primary Endpoint
Presence of serum anti-PCV-1 antibody.

Study Overview

Brief Summary

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

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

Study Design

Study Type
Observational
Time Perspective
Retrospective

Eligibility Criteria

Ages
2 Months to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Presence of serum anti-PCV-1 antibody.

Time Frame: At Day 0 and post vaccination time points (up to 1 month after vaccination).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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