- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05040802
Effectiveness of Adacel Vaccination in Pregnancy at Preventing Pertussis in Infants < 2 Months of Age in the United States
Effectiveness of Adacel Vaccination in Pregnancy at Preventing Pertussis in Infants < 2 Months of Age in the United States (US)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69007
- Sanofi Pasteur
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Cases were included if they met the following inclusion criteria:
- Reported pertussis disease in the referenced EIP surveillance database
- Age greater than 2 days and younger than two months of age
- Resided in the catchment area on date of onset of their cough
- Born in a hospital in their state of residence
- ≥ 37 weeks of gestation at birth
- Not adopted, in foster care or living in a residential care facility
- Completed maternal interview
- Completed infant and maternal information
Controls were included if they met the following inclusion criteria:
- Age greater than 2 days and younger than 2 months of age on date of cough onset for the corresponding case infant
- Resided in the catchment area on date of cough onset for the corresponding case infant
- Born in a hospital in their state of residence
- ≥ 37 weeks of gestation at birth
- Not adopted, in foster care or living in a residential care facility
- Maternal interview completed
- Infant and maternal information complete
Exclusion Criteria:
Cases were excluded if they met any of the following exclusion criteria:
- Vaccination status of the mother unknown
- Infants whose mothers were vaccinated with Boostrix or an unknown vaccine brand
Controls were excluded if they met any of the following exclusion criteria:
- Vaccination status of the mother unknown
- A pertussis diagnosis prior to the cough onset date of the corresponding case infant
- Controls that were matched to Boostrix or an unknown brand cases
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pertussis Case Group
Infants between 2 days to less than 2 months of age for whom a case of pertussis was reported (laboratory confirmed pertussis, epidemiological linkage to a laboratory-confirmed case and/or clinically compatible illness) and who met case inclusion criteria. This post-hoc analysis was limited to infants born of mothers vaccinated with Adacel or who did not receive any tetanus, diphtheria, and acellular pertussis (Tdap) vaccine. |
Not applicable / dataset analysis
|
Control Group
Infants born at the same hospital as the case-infant who were less than 2 months old on the case-infant's cough onset date, and who met control inclusion criteria. This post-hoc analysis was limited to infants born of mothers vaccinated with Adacel or who did not receive any Tdap vaccine. |
Not applicable / dataset analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of pertussis cases in infants less than 2 months and matched controls
Time Frame: During the data collection period (from 01 January 2011 to 31 December 2014)
|
Vaccine effectiveness at preventing pertussis in infants less than 2 months of age was estimated using conditional logistic regression.
|
During the data collection period (from 01 January 2011 to 31 December 2014)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of pertussis cases requiring hospitalization in infants less than 2 months and matched controls
Time Frame: During the data collection period (from 01 January 2011 to 31 December 2014)
|
Vaccine effectiveness at preventing pertussis requiring hospitalization was estimated using conditional logistic regression
|
During the data collection period (from 01 January 2011 to 31 December 2014)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Skoff TH, Blain AE, Watt J, Scherzinger K, McMahon M, Zansky SM, Kudish K, Cieslak PR, Lewis M, Shang N, Martin SW. Impact of the US Maternal Tetanus, Diphtheria, and Acellular Pertussis Vaccination Program on Preventing Pertussis in Infants <2 Months of Age: A Case-Control Evaluation. Clin Infect Dis. 2017 Nov 29;65(12):1977-1983. doi: 10.1093/cid/cix724.
- Vargas-Zambrano JC, Clark LR, Johnson DR, Monfredo C, Pool V, Li L, Bouvet PE, Blangero Y, Macina D. Prenatal tetanus-diphtheria-acellular pertussis vaccine effectiveness at preventing infant pertussis. Vaccine. 2023 Apr 7:S0264-410X(23)00342-0. doi: 10.1016/j.vaccine.2023.03.048. Online ahead of print.
- Finnegan SL, Harrison OK, Booth S, Dennis A, Ezra M, Harmer CJ, Herigstad M, Guillaume B, Nichols TE, Rahman NM, Reinecke A, Renaud O, Pattinson KTS. The effect of d-cycloserine on brain processing of breathlessness over pulmonary rehabilitation: an experimental medicine study. ERJ Open Res. 2023 Apr 3;9(2):00479-2022. doi: 10.1183/23120541.00479-2022. eCollection 2023 Mar.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TD500059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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