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

NCT03973905 | Completed Results

• 1 other identifier: 210031
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Whooping Cough

Keywords

Whooping Cough; Boostrix; Tdap; effectiveness; pregnancy; infants

Outcome Measures

Primary Outcomes (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

  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.

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

Secondary Outcomes (3)

• 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

  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

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

• 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

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

Study Arms (2)

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

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

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

Infant subjects, born to mothers exposed, or unexposed to Boostrix or any Tdap vaccination, coming from 6 emerging program network sites.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Wavre, 1300, Belgium

Location

Related Publications (1)

• 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 BACKGROUND

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

Limitations and Caveats

Due to the specificities of this project, developing both protocol and statistical analysis plan would have been redundant and of no added value. GSK therefore described the planned analysis in a detailed statistical analysis plan.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: June 4, 2019
• Study Start: February 15, 2019
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: July 7, 2020
• Results First Posted: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)