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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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05040802
Enrollment
462
Registered
2021-09-10
Start date
2021-06-02
Completion date
2021-10-04
Last updated
2023-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pertussis (Whooping Cough)

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.

Interventions

Not applicable / dataset analysis

Sponsors

Sanofi Pasteur, a Sanofi Company
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Days to 2 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of pertussis cases in infants less than 2 months and matched controlsDuring 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

MeasureTime frameDescription
Number of pertussis cases requiring hospitalization in infants less than 2 months and matched controlsDuring 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026