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Post-marketing Safety Study of GSK Biological's Pediarix™ Vaccine

NCT00146835 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120794

Last updated 2014-01-13

No results posted yet for this study

Summary

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.

Conditions

  • Hepatitis B
  • Poliomyelitis
  • Diphtheria
  • Tetanus
  • Acellular Pertussis

Interventions

BIOLOGICAL

Pediarix

1 or more injections

BIOLOGICAL

Licensed DTPa containing vaccine

1 or more injections

BIOLOGICAL

Prevnar®: (Wyeth)

Concomitant vaccination

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
6 Weeks
Max Age
9 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2006-06-30
Completion
2006-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00146835 on ClinicalTrials.gov