Brief Title
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
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.
Study Type
Observational
Primary Outcome
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
Secondary Outcome
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
Condition
Whooping Cough
Intervention
Not applicable / dataset analysis
Study Arms / Comparison Groups
Pertussis Case Group
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
290
Start Date
February 15, 2019
Completion Date
May 15, 2019
Primary Completion Date
May 15, 2019
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.
Gender
All
Ages
2 Days - 2 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
GSK Clinical Trials, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT03973905
Organization ID
210031
Responsible Party
Sponsor
Study Sponsor
GlaxoSmithKline
Study Sponsor
GSK Clinical Trials, Study Director, GlaxoSmithKline
Verification Date
July 2020