Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647654
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Impact and Effectiveness of ABRYSVO Vaccination During Pregnancy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Real World Impact and Effectiveness of ABRYSVO Vaccination During Pregnancy Against RSV Illness in Infants
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BERNI
Brief Summary:
This study will be conducted in collaboration with a research network of independent hospital sites to evaluate the vaccine effectiveness VE and impact of ABRYSVO vaccination during pregnancy in a real-world population over multiple seasons beginning in 2024 We will use three retrospective design approaches in this study
i a test negative design TND to evaluate real-world VE of maternal ABRYSVO against RSV-associated outcomes in infants
ii a descriptive cohort design to evaluate the clinical evolution of infants hospitalized with RSV-positive lower respiratory tract disease LRTD and
iii an ecologic before-and-after design to evaluate the population-level impact of ABRYSVO vaccination during pregnancy on infant RSV-associated and all-cause respiratory outcomes
i a test negative design TND to evaluate real-world VE of maternal ABRYSVO against RSV-associated outcomes in infants
ii a descriptive cohort design to evaluate the clinical evolution of infants hospitalized with RSV-positive lower respiratory tract disease LRTD and
iii an ecologic before-and-after design to evaluate the population-level impact of ABRYSVO vaccination during pregnancy on infant RSV-associated and all-cause respiratory outcomes
Detailed Description:
This hospital-based retrospective study will be conducted in a research network of independent hospital sites We will collect data from hospital medical records supplemented with information from the vaccine registry This study will use three retrospective design approaches a test negative design TND to evaluate real-world vaccine effectiveness VE of maternal ABRYSVO against RSV-associated LRTD hospitalization and other outcomes in infants a descriptive cohort design to evaluate the clinical features of infants hospitalized with RSV-positive LRTD and an ecologic before-and-after design to evaluate the impact of ABRYSVO vaccination during pregnancy on infant RSV-associated and all-cause respiratory outcomes
The TND study will include infants through 9 months of age who were admitted to one of the participating hospital sites with symptoms of respiratory infection met the definition of LRTD and had a respiratory specimen collected with an RSV test result through standard of care testing To complement the VE estimates generated in the TND study we will use the cases from the primary objective of the TND analysis as a cohort of participants to describe the endpoints in the descriptive cohort study The ecologic before-and-after study will include information for all children 24 months of age meeting eligibility criteria in post-ABRYSVO program implementation years and in several historical RSV seasons pre-ABRYSVO program implementation
For the TND study a multilevel logistic regression model adjusted for confounding will be used to compute an adjusted odds ratio aOR comparing the odds of maternal ABRYSVO vaccination during pregnancy between test-positive cases and test-negative controls VE will be estimated as 1-aOR x 100 Secondary and exploratory objectives will evaluate VE estimates stratified by several characteristics For the descriptive cohort study of RSV-positive LRTD hospitalized infants 6 months of age ie the cases from the primary objective of the TND study infant characteristics timing severityclinical features and use of healthcare resources during the index hospitalization will be described For the ecologic before-and-after study the impact of maternal ABRYSVO introduction on rates of RSV-associated and all-cause outcomes among infants 6 months compared with older age groups over multiple RSV seasons will be described overall and by epidemiological week calendar year calendar month age group and hospital site These analyses will begin in the 2024 RSV season and continue in future RSV seasons 2025 and 2026 with comparison to several pre-ABRYSVO implementation seasons Quasi-experimental approaches will also be used to quantitatively compare incidence of study outcomes among infants aged 6 months with older age groups
The TND study will include infants through 9 months of age who were admitted to one of the participating hospital sites with symptoms of respiratory infection met the definition of LRTD and had a respiratory specimen collected with an RSV test result through standard of care testing To complement the VE estimates generated in the TND study we will use the cases from the primary objective of the TND analysis as a cohort of participants to describe the endpoints in the descriptive cohort study The ecologic before-and-after study will include information for all children 24 months of age meeting eligibility criteria in post-ABRYSVO program implementation years and in several historical RSV seasons pre-ABRYSVO program implementation
For the TND study a multilevel logistic regression model adjusted for confounding will be used to compute an adjusted odds ratio aOR comparing the odds of maternal ABRYSVO vaccination during pregnancy between test-positive cases and test-negative controls VE will be estimated as 1-aOR x 100 Secondary and exploratory objectives will evaluate VE estimates stratified by several characteristics For the descriptive cohort study of RSV-positive LRTD hospitalized infants 6 months of age ie the cases from the primary objective of the TND study infant characteristics timing severityclinical features and use of healthcare resources during the index hospitalization will be described For the ecologic before-and-after study the impact of maternal ABRYSVO introduction on rates of RSV-associated and all-cause outcomes among infants 6 months compared with older age groups over multiple RSV seasons will be described overall and by epidemiological week calendar year calendar month age group and hospital site These analyses will begin in the 2024 RSV season and continue in future RSV seasons 2025 and 2026 with comparison to several pre-ABRYSVO implementation seasons Quasi-experimental approaches will also be used to quantitatively compare incidence of study outcomes among infants aged 6 months with older age groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None