Rates of Pertussis Disease Among Persons Receiving Pentacel® or Other Pertussis Vaccines
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01129362 |
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Recruitment Status :
Completed
First Posted : May 24, 2010
Last Update Posted : June 25, 2019
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The purpose of this cohort study is to determine vaccine-specific rates of pertussis disease during the period of the study, among Wisconsin residents younger than 60 months of age (the Surveillance Population), and to descriptively compare the proportion of such persons vaccinated with Pentacel® vaccine who acquire pertussis disease to the proportion of such persons vaccinated with any other Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) vaccine who acquire pertussis disease.
Primary Objective:
To determine the rates and relative risk of pertussis disease among Surveillance Population members who have received Pentacel vaccine or another pertussis vaccine.
| Condition or disease | Intervention/treatment |
|---|---|
| Pertussis | Biological: Pentacel® (DTaP-IPV/Hib) Biological: Other Pertussis Vaccines |
The study will be conducted by the University of Wisconsin School of Medicine and Public Health, in collaboration with the Wisconsin Division of Public Health (WDPH).
Epidemiological and laboratory surveillance for pertussis disease among Wisconsin residents is routinely conducted by the WDPH. During the period of the study, de-identified data regarding all incident pertussis cases will be obtained from WDPH and vaccination coverage rates, by vaccine regimen, age group, and period of time, will be obtained from ongoing marketplace surveillance conducted on behalf of the Sponsor by a national sample-survey organization. Using these data, rates of pertussis disease will be determined.
No vaccine will be administered as part of this study.
| Study Type : | Observational |
| Actual Enrollment : | 1195 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Official Title: | Surveillance for Rates of Pertussis Disease Among Persons Birth Through 59 Months of Age Receiving Pentacel® or Other Pertussis Vaccines |
| Actual Study Start Date : | February 8, 2010 |
| Actual Primary Completion Date : | December 30, 2014 |
| Actual Study Completion Date : | December 30, 2014 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Group 1
Participants that only received Pentacel® vaccine.
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Biological: Pentacel® (DTaP-IPV/Hib)
0.5 mL dose, Intramuscular
Other Name: Pentacel® |
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Group 2
Participants that only received a single brand of pertussis vaccine other than Pentacel® vaccine.
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Biological: Other Pertussis Vaccines
0.5 mL, Intramuscular
Other Names:
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Group 3
Participants that received more than one brand of Pertussis vaccine or one or more doses of an unknown brand.
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Biological: Other Pertussis Vaccines
0.5 mL, Intramuscular
Other Names:
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- Occurrence of pertussis disease, as determined by the Wisconsin Division of Public Health (WDPH) [ Time Frame: Up to 5 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | up to 59 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria :
- Persons will be under surveillance for this study whenever the following three conditions are true: the individual resides in Wisconsin, is age birth through 59 months, and is within the surveillance period of 01 October 2009 through 30 September 2014 (or as extended in order to accrue 61,761 person years of Pentacel vaccine exposure).
Exclusion Criteria :
- Not applicable
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129362
| United States, Wisconsin | |
| Madison, Wisconsin, United States, 53701-2659 | |
| Madison, Wisconsin, United States, 53792 | |
| Study Director: | Medical Director | Sanofi Pasteur Inc. |
| Responsible Party: | Sanofi Pasteur, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT01129362 |
| Obsolete Identifiers: | NCT01079039 |
| Other Study ID Numbers: |
M5A16 UTN: U1111-1111-5171 ( Other Identifier: WHO ) |
| First Posted: | May 24, 2010 Key Record Dates |
| Last Update Posted: | June 25, 2019 |
| Last Verified: | June 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/ |
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Respiratory Tract Infections Infection Respiratory Tract Diseases |