Clinical trial NCT03973905: Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States
Official title: Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States: Analysis of a Dataset From a Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Whooping Cough
Keywords: Whooping Cough
Boostrix
Tdap
effectiveness
pregnancy
infants
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2019-06-04
Enrollment: 290
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: Infant subjects, born to mothers exposed, or unexposed to Boostrix or any Tdap vaccination, coming from 6 emerging program network sites.

Brief summary: The purpose of this study is to estimate the effectiveness of maternal immunization with Boostrix at preventing pertussis in infants in the United States.


Eligibility criteria: Inclusion Criteria:

Inclusion criteria for case infants:

* Case infants were eligible for the enrolment if they:
* were at least 2 days old and \< 2 months old on the cough onset date
* resided in the catchment area on their cough onset date
* were born in a hospital in their state of residence
* were ≥37 weeks' gestational age at birth
* were neither adopted nor in foster care
* did not live in a residential care facility

Inclusion criteria for control infants:

* Control infants were eligible for the enrolment if they:
* were at least 2 days old and \<2 months old on the case infant's cough onset date
* were born in a hospital in their state of residence
* were ≥37 weeks' gestational age at birth
* were neither adopted nor in foster care
* did not live in a residential care facility
* were born at the same hospital as the case infant

did not have pertussis diagnosis prior to the cough onset date of the corresponding case infant

Exclusion Criteria:

* Infants (case and controls) whose mothers have received Adacel or mothers without brand information available, as well as controls who were matched to a case whose mother received Adacel or mothers without brand information available, will be excluded from the analysis of the effectiveness of vaccination with Boostrix.

Primary outcomes:
measure: Number of Pertussis Cases and Matched Controls Among Infants Born to Mothers Vaccinated With Boostrix Vaccine (During Third Trimester of Pregnancy) or Not Exposed to Any Tdap Vaccine During Pregnancy
timeFrame: During the data collection period (from 1 January 2011 to 31 December 2014)
Secondary outcomes:
measure: Number of Pertussis Cases and Matched Controls Among Infants Born to Mothers Vaccinated With Boostrix Vaccine (Before Pregnancy, During First or Second Trimester, After Pregnancy) or Not Exposed to Any Tdap Vaccine During Pregnancy
timeFrame: During the data collection period (from 1 January 2011 to 31 December 2014)
measure: Number of Pertussis Cases and Matched Controls Among Infants Born to Mothers Vaccinated With Boostrix Vaccine (During First, Second or Third Trimester) or Not Exposed to Any Tdap Vaccine During Pregnancy
timeFrame: During the data collection period (from 1 January 2011 to 31 December 2014)
measure: Number of Pertussis Cases Leading to Hospitalization and Matched Controls in Infants Born to Mothers Vaccinated With Boostrix (Before Pregnancy, During First or Second, Third Trimester, After Pregnancy) or Not Exposed to Any Tdap Vaccine During Pregnancy
timeFrame: During the data collection period (from 1 January 2011 to 31 December 2014)
Other outcomes:
Locations:
city: Wavre
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
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.