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Post-Marketing Safety Study of GSK Biological''s Pediarix™ Vaccine. - Article


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Spondyloepimetaphyseal dysplasia, Strudwick type

Dappled metaphysis syndrome; SED Strudwick; SEMD, Strudwick type; SMED, Strudwick type; SMED, type I; Spondylometaepiphyseal dysplasia congenita, Strudwick type; Spondylometaphyseal dysplasia (SMD); Spondylometaphyseal Dysplasia, Strudwick Type; Strudwick syndrome

Clinical Trial: Post-Marketing Safety Study of GSK Biological''s Pediarix™ Vaccine.

This study has been completed.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00146835

Purpose

Pre-licensure studies of GSK Biologicals'''' PEDIARIX vaccine have shown it to be generally safe and unlikely to result in vaccine-associated serious adverse events. This post-licensure study is designed to evaluate relatively uncommon/rare outcomes in a large population cohort.
Condition Intervention Phase
Prophylaxis: Diphtheria, tetanus, pertussis, hepatitis B, poliovirus type 1, type 2 and type 3
  Vaccine: Diphtheria, tetanus, pertussis, hepatitis B, poliovirus type 1, type 2 and type 3
 Phase IV

MedlinePlus consumer health information 

Study Type: Observational
Study Design: Longitudinal, Defined Population, Prospective Study

Official Title: Phase IV, Prospective, Study of the Safety of GSK Biologicals'''' Pediarix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined) Administered to a Cohort of Infants in a US Health Maintenance Organization (HMO)

Further Study Details: 

Expected Total Enrollment:  40000

Study start: April 2003

"• The outcomes to be assessed include the occurrence of all seizures (with or without fever), medically-attended fever, seizures associated with fever, allergic reactions, outpatient visits and hospitalizations for any cause, and all deaths.

• Data collection through utilization of automated databases at the study site with subset medical record review."

Eligibility

Ages Eligible for Study:  1 Month   -   9 Months,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria
All infants from the HMO who have begun their primary course of vaccine with PEDIARIX co-administered with Prevnar vaccine.

Location Information


California
      Torrance,  California,  90502,  United States

Study chairs or principal investigators

Clinical Trials,  Study Director,  GlaxoSmithKline   

More Information

Study ID Numbers:  217744
Last Updated:  September 6, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00146835
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005


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September 5, 2008


Page Updated: September 6, 2005
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