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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Presence of Materials From PCV-1

Treatments: Procedure: Serum sample

Study type: Observational

Funder types: Industry

Identifiers

NCT01651247

213503/048

217744/085

114535

Details and patient eligibility

About

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.

Full description

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

Enrollment: 1 patient

Sex: All

Ages: 2 months to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1 participants in 2 patient groups

Group A

Description:

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).

Treatment:

Procedure: Serum sample

Group B

Description:

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).

Treatment:

Procedure: Serum sample