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

NCT01651247 | Completed

• 3 other identifiers: 114535213503/048217744/085
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Presence of Materials From PCV-1

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Presence of serum anti-PCV-1 antibody.

  At Day 0 and post vaccination time points (up to 1 month after vaccination).

Study Arms (2)

Group A

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).

Procedure: Serum sample

Group B

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).

Procedure: Serum sample

Interventions

Serum sample PROCEDURE

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.

Group A; Group B

Eligibility Criteria

• Age: 2 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants aged 2 and 6 months who were previously given a primary vaccination series consisting of a single dose of combination DTaP-HepB-IPV (PEDIARIX®) vaccine at 2, 4, and 6 months of age or separately administered DTaP (INFANRIX®), HepB (ENGERIX-B®), and IPV (Sanofi-Pasteur's IPOL) vaccines in the study 217744/085 and toddlers aged 4-6 years who were previously vaccinated with a single dose of either the combination DTaP-IPV (KINRIX®) vaccine or separately administered DTaP and IPV vaccines in the study 213503/048.

You may qualify if:

• 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.

You may not qualify if:

• Not Applicable

Sponsors & Collaborators

• GlaxoSmithKline: lead

Biospecimen

Retention: SAMPLES WITH DNA

Serum

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 27, 2012
• Study Start: May 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 27, 2012

Record last verified: 2012-07