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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01651247

Enrollment

Registered

2012-07-27

Start date

2010-05-31

Completion date

2010-05-31

Last updated

2012-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presence of Materials From PCV-1

Keywords

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

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.

Interventions

PROCEDURESerum 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.

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Months to 6 Years

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026