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

GlaxoSmithKline1 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Presence of Materials From PCV-1

Interventions

Serum samplePROCEDURE

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.

Medical Language ↔ Plain English

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

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes