Clinical trial NCT05040802: Effectiveness of Adacel Vaccination in Pregnancy at Preventing Pertussis in Infants < 2 Months of Age in the United States
Official title: Effectiveness of Adacel Vaccination in Pregnancy at Preventing Pertussis in Infants < 2 Months of Age in the United States (US)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pertussis (Whooping Cough)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2021-09-10
Enrollment: 462
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants between 2 days to \< 2 months of age for whom a case of pertussis was reported to one of 6 Emerging Infection Program (EIP) network sites included in the original Skoff et al. study (in 2017) and their respective control infants, for the study period.

Brief summary: The purpose of this study is to determine the effectiveness of Adacel against pertussis disease in infants \< 2 months when administered during pregnancy following the current Advisory Committee on Immunization Practices (ACIP) recommendations, i.e., from 27 to 36 weeks of gestation, and 14 days or more before delivery.

Detailed description: The original study included cases recorded from 01 January 2011 through 31 December 2014, based on retrospective case-control methodology.

Eligibility criteria: 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

Primary outcomes:
measure: Number of pertussis cases in infants less than 2 months and matched controls
timeFrame: During the data collection period (from 01 January 2011 to 31 December 2014)
Secondary outcomes:
measure: Number of pertussis cases requiring hospitalization in infants less than 2 months and matched controls
timeFrame: During the data collection period (from 01 January 2011 to 31 December 2014)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Sanofi Pasteur
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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 May 2;41(18):2968-2975. doi: 10.1016/j.vaccine.2023.03.048. Epub 2023 Apr 7.