Not Signed In -
Ehlers-Danlos syndrome, vascular type |
Sack-Barabas syndrome |
Clinical Trial: Post-Marketing Safety Study of GSK Biological''s Pediarix™ Vaccine.
This study has been completed.
|
Purpose
| 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)
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
Accepts Healthy Volunteers
Location Information
California
Torrance, California, 90502, United States
Clinical Trials, Study Director, GlaxoSmithKline
More Information
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
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