Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States
3 juillet 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Réel)
290
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Wavre, Belgique, 1300
- GSK Investigational Site
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
2 jours à 2 mois (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Infant subjects, born to mothers exposed, or unexposed to Boostrix or any Tdap vaccination, coming from 6 emerging program network sites.
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas-témoins
- Perspectives temporelles: Rétrospective
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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. |
Non applicable / analyse des ensembles de données
|
|
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 applicable / analyse des ensembles de données
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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
Délai: 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)
|
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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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
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Publications et liens utiles
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 février 2019
Achèvement primaire (Réel)
15 mai 2019
Achèvement de l'étude (Réel)
15 mai 2019
Dates d'inscription aux études
Première soumission
13 février 2019
Première soumission répondant aux critères de contrôle qualité
3 juin 2019
Première publication (Réel)
4 juin 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 juillet 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 juillet 2020
Dernière vérification
1 juillet 2020
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 210031
Plan pour les données individuelles des participants (IPD)
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Non
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