Database Surveillance Safety Study of PENTACEL® Vaccine
NCT ID: NCT00804284
Last Updated: 2015-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
62538 participants
OBSERVATIONAL
2008-09-30
2015-01-31
Brief Summary
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Detailed Description
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Vaccination databases will be reviewed to identify Diphtheria and tetanus toxoid with acellular pertussis (DTaP) vaccinations of accrued subjects. Medical encounter, emergency room, hospitalization, laboratory, state death reporting, and related databases will be reviewed to identify medical care events.
Conditions
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Study Design
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COHORT
Study Groups
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Pentacel Group
Infants initiated on PENTACEL® vaccine
DTaP-IPV/Hib
0.5 mL, Intramuscular
Other DTap vaccines Group
Infants initiated on other DTaP vaccines
Other DTap Vaccines
0.5 mL, Intramuscular
Interventions
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DTaP-IPV/Hib
0.5 mL, Intramuscular
Other DTap Vaccines
0.5 mL, Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Weeks
24 Months
MALE
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc
Locations
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Oakland, California, United States
Countries
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References
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Hansen J, Timbol J, Lewis N, Pool V, Decker MD, Greenberg DP, Klein NP. Safety of DTaP-IPV/Hib vaccine administered routinely to infants and toddlers. Vaccine. 2016 Jul 29;34(35):4172-4179. doi: 10.1016/j.vaccine.2016.06.062. Epub 2016 Jun 30.
Related Links
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Related Info
Other Identifiers
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M5A11
Identifier Type: -
Identifier Source: org_study_id
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