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Database Surveillance Safety Study of PENTACEL® Vaccine

NCT00804284 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 62538

Last updated 2015-08-19

No results posted yet for this study

Summary

The objective for this study is to characterize the safety profile of PENTACEL® vaccine for identification of potential vaccine-related adverse events not currently associated with PENTACEL® vaccine administration.

Conditions

  • Diphtheria
  • Tetanus
  • Pertussis
  • Haemophilus Influenzae

Interventions

BIOLOGICAL

DTaP-IPV/Hib

0.5 mL, Intramuscular

BIOLOGICAL

Other DTap Vaccines

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc

Eligibility

Min Age
6 Weeks
Max Age
24 Months
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2014-08-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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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 NCT00804284 on ClinicalTrials.gov