Database Surveillance Safety Study of PENTACEL® Vaccine

Tetanus Clinical Trial

Official title:

Post-Licensure Safety Surveillance Study of Routine Use of PENTACEL® Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804284
• Other study ID #: M5A11
• Status: Completed
• Phase: N/A
• First received: December 5, 2008
• Last updated: August 17, 2015
• Start date: September 2008
• Est. completion date: January 2015

Study information

• Verified date: August 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

The study will be conducted at Kaiser Permanente Northern California and will commence with first use of licensed PENTACEL® vaccine within that organization.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62538
• Est. completion date: January 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 6 Weeks to 24 Months

Eligibility

Inclusion Criteria:

• Receipt of DTaP vaccine during the study period by a previously unvaccinated child

Exclusion Criteria:

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenzae
• Pertussis
• Tetanus
• Whooping Cough

Intervention

Biological:
• DTaP-IPV/Hib
0.5 mL, Intramuscular
• Other DTap Vaccines
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A summary of all non-elective hospitalization and emergency room visits as well as outcome of interest from chart review.	Outcome of interest identified from Kaiser Permanente Medical Care Program (KPMCP) computerized records via International Classification of Diseases, 9th edition (ICD-9) codes, defined as: Death,; Outpatient clinic visit for: seizure occurring within 72 hours of vaccination, Guillain-Barré Syndrome, encephalopathy, encephalitis, alteration of consciousness (other than secondary to another diagnosis), or meningitis; hypersensitivity reactions (e.g. urticaria, angioedema, or anaphylaxis) occurring within 72 hours of vaccination,; new-onset autoimmune disease (including idiopathic thrombocytopenic purpura, hemolytic anemia).	Up to 6 months post -dose 4 DTap Vaccination	No

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