Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States
3 juli 2020 uppdaterad av: GlaxoSmithKline
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
The purpose of this study is to estimate the effectiveness of maternal immunization with Boostrix at preventing pertussis in infants in the United States.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Faktisk)
290
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Wavre, Belgien, 1300
- GSK Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
2 dagar till 2 månader (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
Infant subjects, born to mothers exposed, or unexposed to Boostrix or any Tdap vaccination, coming from 6 emerging program network sites.
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Case-Control
- Tidsperspektiv: Retrospektiv
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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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. |
Ej tillämpligt / datasetanalys
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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. |
Ej tillämpligt / datasetanalys
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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
Tidsram: During the data collection period (from 1 January 2011 to 31 December 2014)
|
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.
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During the data collection period (from 1 January 2011 to 31 December 2014)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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
Tidsram: During the data collection period (from 1 January 2011 to 31 December 2014)
|
Vaccine effectiveness at preventing pertussis occurrence in infants < 2 months old is assessed by comparing the Boostrix immunization status before pregnancy, during first or second pregnancy trimester, after pregnancy 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)
|
|
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
Tidsram: During the data collection period (from 1 January 2011 to 31 December 2014)
|
Vaccine effectiveness at preventing pertussis occurrence in infants < 2 months old is assessed by comparing the Boostrix immunization status during pregnancy 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)
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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
Tidsram: During the data collection period (from 1 January 2011 to 31 December 2014)
|
Vaccine effectiveness at preventing pertussis occurrence leading to hospitalization in infants < 2 months old is assessed by comparing the Boostrix immunization status before pregnancy, during first or second, third trimester, after pregnancy 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.
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During the data collection period (from 1 January 2011 to 31 December 2014)
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Studieavstämningsdatum
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Studera stora datum
Studiestart (Faktisk)
15 februari 2019
Primärt slutförande (Faktisk)
15 maj 2019
Avslutad studie (Faktisk)
15 maj 2019
Studieregistreringsdatum
Först inskickad
13 februari 2019
Först inskickad som uppfyllde QC-kriterierna
3 juni 2019
Första postat (Faktisk)
4 juni 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
7 juli 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 juli 2020
Senast verifierad
1 juli 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 210031
Plan för individuella deltagardata (IPD)
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Nej
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