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

GlaxoSmithKline290 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

290

Conditions

Whooping Cough

Interventions

Not applicable / dataset analysisOTHER

Not applicable / dataset analysis

Eligibility

Sex: ALLMin age: 2 DaysMax age: 2 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Wavre, Belgium

Outcomes

Primary Outcomes

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

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.

Time frame: During the data collection period (from 1 January 2011 to 31 December 2014)

Secondary Outcomes

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

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.

Time frame: During the data collection period (from 1 January 2011 to 31 December 2014)

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

Data from ClinicalTrials.gov

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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

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.

Time frame: During the data collection period (from 1 January 2011 to 31 December 2014)