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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Whooping Cough

Treatments: Other: Not applicable / dataset analysis

Study type: Observational

Funder types: Industry

Identifiers

NCT03973905

210031

Details and patient eligibility

About

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

Enrollment: 290 patients

Sex: All

Ages: 2 days to 2 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

290 participants in 2 patient 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.

Treatment:

Other: Not applicable / dataset analysis

Control Group

Description:

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.

Treatment:

Other: Not applicable / dataset analysis