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

Completed

• Conditions: Presence of Materials From PCV-1
• Interventions: Procedure: Serum sample

• Registration Number: NCT01651247
• Lead Sponsor: GlaxoSmithKline

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 Timeline

• Study Start: 2010-05
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-07
• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-24
• Last Update Submitted: 2012-07-24
• Study First Posted: 2012-07-27
• Last Update Posted: 2012-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Serum sample	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).
Group B	Serum sample	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).

Primary Outcome Measures

Name	Time	Method
Presence of serum anti-PCV-1 antibody.	At Day 0 and post vaccination time points (up to 1 month after vaccination).