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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- 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