PertussisNCT01129362
Rates of Pertussis Disease Among Persons Receiving Pentacel® or Other Pertussis Vaccines
An observational study of Pertussis, run by Sanofi Pasteur, a Sanofi Company at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Pertussis
- What is being tested?
- Pentacel® (DTaP-IPV/Hib) and Other Pertussis Vaccines
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 1,195 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Feb 2010to 30 Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Wisconsin residents younger than 60 months of age.
Who may be able to join
- 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).
Who cannot join
- Not applicable
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Madison, Wisconsin, 53701-2659
Study site
Madison, Wisconsin, 53792
About this study
Official title: Surveillance for Rates of Pertussis Disease Among Persons Birth Through 59 Months of Age Receiving Pentacel® or Other Pertussis Vaccines
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.
Read the detailed description
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.
- Conditions
- Pertussis
- Being tested
- Pentacel® (DTaP-IPV/Hib), Other Pertussis Vaccines
- Keywords
- Pertussis, Whooping Cough, Pertussis Vaccine
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentacel® (DTaP-IPV/Hib)Biological
Also called Pentacel®
0.5 mL dose, Intramuscular
Other Pertussis VaccinesBiological
Also called DAPTACEL®, Tripedia®, TriHIBit®, Infanrix®
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Participants that only received Pentacel® vaccine. Receives: Biological: Pentacel® (DTaP-IPV/Hib) | |
| Group 2 | Participants that only received a single brand of pertussis vaccine other than Pentacel® vaccine. Receives: Biological: Other Pertussis Vaccines | |
| Group 3 | Participants that received more than one brand of Pertussis vaccine or one or more doses of an unknown brand. Receives: Biological: Other Pertussis Vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of pertussis disease, as determined by the Wisconsin Division of Public Health (WDPH)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study start8 Feb 2010
- Primary completion30 Dec 2014
- Study completion30 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PertussisStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129362
- Sponsor's protocol ID
- M5A16
- Other IDs
- UTN: U1111-1111-5171
- Status last verified
- Apr 2022
- First submitted
- 20 May 2010
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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://vivli.org
Publications
Conway JH, Davis JP, Eickhoff JC, Pool V, Greenberg DP, Decker MD. Brand-specific rates of pertussis disease among Wisconsin children given 1-4 doses of pertussis Vaccine, 2010-2014. Vaccine. 2020 Oct 21;38(45):7063-7069. doi: 10.1016/j.vaccine.2020.09.016. Epub 2020 Sep 11.
PubMed 32921507Decker MD, Hosbach P, Johnson DR, Pool V, Greenberg DP. Estimating the effectiveness of tetanus-diphtheria-acellular pertussis vaccine. J Infect Dis. 2015 Feb 1;211(3):497-8. doi: 10.1093/infdis/jiu477. Epub 2014 Aug 25. No abstract available.
PubMed 25156560
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance for Rates of Pertussis Disease Among Persons Birth Through 59 Months of Age Receiving Pentacel® or Other Pertussis Vaccines
- ClinicalTrials.gov ID
- NCT01129362
- Acronym / sponsor ID
- M5A16
- Conditions
- Pertussis
- Keywords
- Pertussis, Whooping Cough, Pertussis Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,195 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2010 (actual)
- Primary completion
- 30 Dec 2014 (actual)
- Study completion
- 30 Dec 2014 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Biological: Pentacel® (DTaP-IPV/Hib)Participants that only received Pentacel® vaccine. |
| Group 2 | – | Biological: Other Pertussis VaccinesParticipants that only received a single brand of pertussis vaccine other than Pentacel® vaccine. |
| Group 3 | – | Biological: Other Pertussis VaccinesParticipants that received more than one brand of Pertussis vaccine or one or more doses of an unknown brand. |
Who may qualify
- Ages
- Up to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Wisconsin residents younger than 60 months of age.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pentacel® (DTaP-IPV/Hib)Also: Pentacel®0.5 mL dose, Intramuscular | Biological | Group 1 |
| Other Pertussis VaccinesAlso: DAPTACEL®, Tripedia®, TriHIBit®, Infanrix®0.5 mL, Intramuscular | Biological | Group 2, Group 3 |
Primary outcome
Occurrence of pertussis disease, as determined by the Wisconsin Division of Public Health (WDPH)
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Derived from this study: PubMed 32921507Conway JH, Davis JP, Eickhoff JC, Pool V, Greenberg DP, Decker MD. Brand-specific rates of pertussis disease among Wisconsin children given 1-4 doses of pertussis Vaccine, 2010-2014. Vaccine. 2020 Oct 21;38(45):7063-7069. doi: 10.1016/j.vaccine.2020.09.016. Epub 2020 Sep 11.
- Derived from this study: PubMed 25156560Decker MD, Hosbach P, Johnson DR, Pool V, Greenberg DP. Estimating the effectiveness of tetanus-diphtheria-acellular pertussis vaccine. J Infect Dis. 2015 Feb 1;211(3):497-8. doi: 10.1093/infdis/jiu477. Epub 2014 Aug 25. No abstract available.
- Individual participant dataSharing planned: Yes. 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://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Sanofi Pasteur Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertussis, run by Sanofi Pasteur, a Sanofi Company at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of pertussis disease, as determined by the Wisconsin Division of Public Health (WDPH) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01129362, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.