Effectiveness of Adacel Vaccination in Pregnancy at Preventing Pertussis in Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

462 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-02

Study Completion Date

2021-10-04

Brief Summary

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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.

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Detailed Description

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

Conditions

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Pertussis (Whooping Cough)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Intervention Type OTHER

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

Intervention Type OTHER

Not applicable / dataset analysis

Interventions

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Not applicable / dataset analysis

Intervention Type OTHER

Eligibility Criteria

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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

* 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

* Vaccination status of the mother unknown
* Infants whose mothers were vaccinated with Boostrix or an unknown vaccine brand

* 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

Minimum Eligible Age

2 Days

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes