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

NCT05040802 | Completed

• 1 other identifier: TD500059
• Study Type: observational
• Target: 462
• Locations: 1 country
• Sites: 1

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.

Conditions

Pertussis (Whooping Cough)

Outcome Measures

Primary Outcomes (1)

• Number of pertussis cases in infants less than 2 months and matched controls

  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 Outcomes (1)

• 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)

Study Arms (2)

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.

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.

Other: Not applicable / dataset analysis

Interventions

Not applicable / dataset analysis OTHER

Not applicable / dataset analysis

Control Group; Pertussis Case Group

Eligibility Criteria

• Age: 2 Days - 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Sanofi Pasteur

Lyon, 69007, France

Location

Related Publications (2)

• 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.

  PMID: 29028938 RESULT

• 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.

  PMID: 37032227 RESULT

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 10, 2021
• Study Start: June 2, 2021
• Primary Completion: October 4, 2021
• Study Completion: October 4, 2021
• Last Updated: April 13, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)