N/A
N=290
Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States
Whooping Cough
Bottom Line
View on ClinicalTrials.gov: NCT03973905 ↗Enrolled (actual)
290
Serious AEs
—
Results posted
Jul 2020
Primary outcome: Primary: 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 — 72; 112; 5; 17 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Not applicable / dataset analysis (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
72; 112; 5; 17 | — |
| SECONDARY 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 |
72; 112; 1; 4; 1; 6 | — |
| SECONDARY 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 |
72; 112; 6; 23 | — |
| SECONDARY 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 |
49; 78; 1; 2; 0; 5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03973905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.