Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States
3 luglio 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Osservativo
Iscrizione (Effettivo)
290
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Wavre, Belgio, 1300
- GSK Investigational Site
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 2 giorni a 2 mesi (Bambino)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
Infant subjects, born to mothers exposed, or unexposed to Boostrix or any Tdap vaccination, coming from 6 emerging program network sites.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso di controllo
- Prospettive temporali: Retrospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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. |
Non applicabile / analisi del set di dati
|
|
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. |
Non applicabile / analisi del set di dati
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: 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.
|
During the data collection period (from 1 January 2011 to 31 December 2014)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: 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
Lasso di tempo: 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)
|
|
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
Lasso di tempo: 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.
|
During the data collection period (from 1 January 2011 to 31 December 2014)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
15 febbraio 2019
Completamento primario (Effettivo)
15 maggio 2019
Completamento dello studio (Effettivo)
15 maggio 2019
Date di iscrizione allo studio
Primo inviato
13 febbraio 2019
Primo inviato che soddisfa i criteri di controllo qualità
3 giugno 2019
Primo Inserito (Effettivo)
4 giugno 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
7 luglio 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 luglio 2020
Ultimo verificato
1 luglio 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 210031
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .