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Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States

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ClinicalTrials.gov Identifier: NCT03973905
Recruitment Status : Completed
First Posted : June 4, 2019
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment
Whooping Cough Other: Not applicable / dataset analysis

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Study Type : Observational
Actual Enrollment : 290 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Actual Study Start Date : February 15, 2019
Actual Primary Completion Date : May 15, 2019
Actual Study Completion Date : May 15, 2019


Group/Cohort Intervention/treatment
Pertussis Case Group

Infant subjects of at least 2 days old and less than (<) 2 months old, who met the pertussis diagnosis definition (laboratory confirmed pertussis, epidemiological linkage to a laboratory-confirmed case, clinically compatible illness), and who met the case infants inclusion criteria (resided in the catchment area on their cough onset date, were born in a hospital in their state of residence, had at least 37 weeks gestational age at birth, were neither adopted, nor in foster care and did not live in a residential care facility).

This post-hoc analysis was limited to cases and controls whose mothers were either vaccinated with Boostrix or did not receive any Tdap vaccine. Cases with no remaining matched control were also excluded from the analysis and vice versa.

Other: Not applicable / dataset analysis
Not applicable / dataset analysis

Control Group

Infant subjects of at least 2 days old and less than (<) 2 months old, who did not have a pertussis diagnosis prior to the cough onset date and who met the inclusion criteria for control infants (were born on a hospital in their state of residence, were at least 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).

This post-hoc analysis was limited to cases and controls whose mothers were either vaccinated with Boostrix or did not receive any Tdap vaccine. Cases with no remaining matched control were also excluded from the analysis and vice versa.

Other: Not applicable / dataset analysis
Not applicable / dataset analysis




Primary Outcome Measures :
  1. 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 [ Time Frame: During the data collection period (from 1 January 2011 to 31 December 2014) ]
    Vaccine effectiveness at preventing pertussis occurrence in infants < 2 months old is assessed by comparing the Boostrix immunization status during the third pregnancy trimester in mothers of infant pertussis cases and matched controls. The association between maternal Boostrix vaccination and pertussis in infants was analyzed using conditional logistic regression. The multivariate analysis was performed to obtain the adjusted values. Covariates that were statistically significant in the univariate analysis or considered as clinically significant were included in the multivariable conditional logistic regression model. Subjects with missing or unknown values, if any, for at least one of the risk factors were excluded from the model.


Secondary Outcome Measures :
  1. 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 [ Time Frame: During the data collection period (from 1 January 2011 to 31 December 2014) ]
    Vaccine effectiveness at preventing pertussis occurrence in infants < 2 months old is assessed by comparing the Boostrix immunization status before pregnancy, during first or second pregnancy trimester, after pregnancy in mothers of infant pertussis cases and matched controls. The association between maternal Boostrix vaccination and pertussis in infants was analyzed using conditional logistic regression. The multivariate analysis was performed to obtain the adjusted values. Covariates that were statistically significant in the univariate analysis or considered as clinically significant were included in the multivariable conditional logistic regression model. Subjects with missing or unknown values, if any, for at least one of the risk factors were excluded from the model.

  2. 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 [ Time Frame: During the data collection period (from 1 January 2011 to 31 December 2014) ]
    Vaccine effectiveness at preventing pertussis occurrence in infants < 2 months old is assessed by comparing the Boostrix immunization status during pregnancy in mothers of infant pertussis cases and matched controls. The association between maternal Boostrix vaccination and pertussis in infants was analyzed using conditional logistic regression. The multivariate analysis was performed to obtain the adjusted values. Covariates that were statistically significant in the univariate analysis or considered as clinically significant were included in the multivariable conditional logistic regression model. Subjects with missing or unknown values, if any, for at least one of the risk factors were excluded from the model.

  3. 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 [ Time Frame: During the data collection period (from 1 January 2011 to 31 December 2014) ]
    Vaccine effectiveness at preventing pertussis occurrence leading to hospitalization in infants < 2 months old is assessed by comparing the Boostrix immunization status before pregnancy, during first or second, third trimester, after pregnancy in mothers of infant pertussis cases and matched controls. The association between maternal Boostrix vaccination and pertussis in infants was analyzed using conditional logistic regression. The multivariate analysis was performed to obtain the adjusted values. Covariates that were statistically significant in the univariate analysis or considered as clinically significant were included in the multivariable conditional logistic regression model. Subjects with missing or unknown values, if any, for at least one of the risk factors were excluded from the model.



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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973905


Locations
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Belgium
GSK Investigational Site
Wavre, Belgium, 1300
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Statistical Analysis Plan  [PDF] March 8, 2019
Study Protocol  [PDF] June 24, 2020

Publications:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03973905    
Other Study ID Numbers: 210031
First Posted: June 4, 2019    Key Record Dates
Results First Posted: July 7, 2020
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by GlaxoSmithKline:
Whooping Cough
Boostrix
Tdap
effectiveness
pregnancy
infants
Additional relevant MeSH terms:
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Whooping Cough
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection