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
- 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.
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
- 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).
- Secondary Outcome Measures
Name Time Method