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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01651247
First received: July 12, 2012
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Presence of Materials From PCV-1
 Procedure: Serum sample

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Presence of serum anti-PCV-1 antibody. [ Time Frame: At Day 0 and post vaccination time points (up to 1 month after vaccination). ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum


Enrollment: 1
Study Start Date: May 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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 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
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   2 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651247

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01651247     History of Changes
Other Study ID Numbers: 114535, 213503/048, 217744/085
Study First Received: July 12, 2012
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Toddlers
Retrospective
Porcine circovirus type 1 (PCV-1)
 Infants
Laboratory evaluations
IPV

ClinicalTrials.gov processed this record on May 21, 2013