Last updated: 11/20/2023 05:00:26
Effectiveness of maternal immunization with Boostrix at preventing pertussis among infants <2 Months old in the United States
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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
Trial description: The purpose of this study is to estimate the effectiveness of maternal immunization with Boostrix at preventing pertussis in infants in the United States.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: During the data collection period (from 1 January 2011 to 31 December 2014)
Interventions:
Other: Not applicable / dataset analysis
Enrollment:
290
Observational study model:
Case-Control
Primary completion date:
2019-15-05
Time perspective:
Retrospective
Clinical publications:
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. PMID:29028938
Callegaro A, Caterina S, Cheuvart B, DORMAL G, Meyer N, Poirrier J, et al. . Boostrix_EPI-PERT-052 MS_The effectiveness of maternal immunization with a 3-component acellular pertussis vaccine at preventing pertussis among infants <2 months old in the United States: post-hoc sub-analysis of a case-control study_(FxD). Vaccine.
DOI: 10.1016/j.vaccine.2023.07.057 PMID: 37635001
Medical condition
Whooping cough
Product
GSK2647153A
Collaborators
Not applicable
Study date(s)
February 2019 to May 2019
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
2 Days - 2 Months
Accepts healthy volunteers
Yes
- Inclusion criteria for case infants:
- Case infants were eligible for the enrolment if they:
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Inclusion criteria for case infants:
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 location(s)
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2019-15-05
Actual study completion date
2019-15-05
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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