Effectiveness of Adacel Vaccination in Pregnancy at Preventing Pertussis in Infants < 2 Months of Age in the United States

Completed

• Conditions: Pertussis (Whooping Cough)

• Registration Number: NCT05040802
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Study Timeline

• Study Start: 2021-06-02
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-10
• Primary Completion: 2021-10-04
• Study Completion: 2021-10-04
• Status Verified: 2022-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 462

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of pertussis cases in infants less than 2 months and matched controls	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.

Secondary Outcome Measures

Name	Time	Method
Number of pertussis cases requiring hospitalization in infants less than 2 months and matched controls	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

Trial Locations

Locations (1)

Sanofi Pasteur; 🇫🇷 Lyon, France