Expired Study
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Oakland, California 94612


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Receipt of DTaP vaccine during the study period by a previously unvaccinated child Exclusion Criteria: - None


Study is Available At:


Original ID:

M5A11


NCT ID:

NCT00804284


Secondary ID:


Study Acronym:


Brief Title:

Database Surveillance Safety Study of PENTACEL® Vaccine


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Male


Minimum Age:

6 Weeks


Maximum Age:

24 Months


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sanofi


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

62538


Enrollment Type:

Actual


Overall Contact Information

Official Name:Medical Director
Study Director
Sanofi Pasteur Inc

Study Dates

Start Date:September 2008
Completion Date:January 2015
Completion Type:Actual
Primary Completion Date:August 2014
Primary Completion Type:Actual
Verification Date:August 2015
Last Changed Date:August 17, 2015
First Received Date:December 5, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:A summary of all non-elective hospitalization and emergency room visits as well as outcome of interest from chart review.
Time Frame:Up to 6 months post -dose 4 DTap Vaccination
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Biological
Name:DTaP-IPV/Hib
Description:0.5 mL, Intramuscular
Arm Name:Pentacel Group
Other Name:PENTACEL®
Intervention Type:Biological
Name:Other DTap Vaccines
Description:0.5 mL, Intramuscular
Arm Name:Other DTap vaccines Group
Other Name:DAPTACEL®

Study Arms

Study Arm Type:Other
Arm Name:Other DTap vaccines Group
Description:Infants initiated on other DTaP vaccines
Study Arm Type:Other
Arm Name:Pentacel Group
Description:Infants initiated on PENTACEL® vaccine

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Sanofi Pasteur, a Sanofi Company

Samples and Retentions

Study Population: Receipt of DTaP vaccine during the study period by a previously unvaccinated subjects
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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