Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511687
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Effectiveness And Impact Of Nirsevimab In Chile NIRSE-CL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness And Impact of Nirsevimab In A Nationwide Immunization Program During The 2024 Winter Campaign In Chile Nirse-CL
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
The Nirse-CL study is a collaborative effort between the Ministry of Health of Chile Instituto Sistemas Complejos de Ingeniería ISCI and the Faculty of Medicine of the University of Chile The primary aim is to determine the effectiveness of the monoclonal antibody nirsevimab in preventing RSV infection in infants based on the integrated analysis of several national databases before during and after the implementation of a universal immunization program The impact of the program on RSV-related health outcomes will also be determined
Detailed Description:
The primary aim of NirseCL is to evaluate the effectiveness of nirsevimab against Respiratory Syncytial Virus RSV in infants during the 2024 RSV season in Chile The secondary objective is to determine the impact on RSV-related health outcomes at a national level
The target population to receive nirsevimab is approximately 160000 subjects including the entire newborn cohort born during the autumn-winter season from April 1st 2024 to September 31st 2024 infants born from October 1st 2023 to March 31st 2024 which are 6 to 1 month old at the time of immunization in April-June and the high-risk group defined as infants born with 29 weeks of gestational age wga or less who were born within nine months of the beginning of the RSV season those born with Bronchopulmonary Dysplasia BPD 32 or less wga andor a birth weight less than 15 kgs born within one year of the beginning of the RSV season and newborns 34 or less wga andor weight less than 25 kgs born during the RSV season
Nirsevimab will be administered as part of Chiles national immunization program following the implementation plan designed by the Ministry of Health The coverage with nirsevimab in the target population is expected to be high 95 for those born during the winter campaign and 80 for those born before the beginning of the autumn-winter season
The primary outcome measure for effectiveness will be lower-tract respiratory infection hospitalizations LRTI attributed to RSV in the pediatric intensive care units PICU at a nationwide and regional level and the secondary outcomes will be overall LRTI hospitalizations attributed to RSV LRTI hospitalizations and hospitalizations due to any cause Additional outcomes might be included if enough statistical power is attained
Effectiveness will be determined using a two-step process First historical data will be used to determine the set of ICD10 diagnosis codes that are attributable to RSV infection by using data from the Chilean national sentinel program and consolidated hospitalization records Afterward A series of complementary statistical analyses at different aggregation levels will be conducted to estimate the impact of nirsevimab on the target population Detailed patient-level information will be used to compare LRTI hospitalizations of those receiving the immunization against those who did not using an adjusted proportional hazard rates regression model to estimate the effectiveness of nirsevimab as a function of covariates such as wga weight at birth sex nationality maternal education coexisting conditions MMR vaccination as an indicator of access to medical care and place of birth This method has been used to evaluate recent nationwide vaccination campaigns in Chile Jara et al 2021 A case-control matching approach will be used as an alternative method intended to gain statistical efficiency Rose and van der Laan 2009 Finally as a robustness analysis a synthetic control method that allows the comparison of whole time series without relying on individual-level data will be used Bruhn et al 2016
The target population to receive nirsevimab is approximately 160000 subjects including the entire newborn cohort born during the autumn-winter season from April 1st 2024 to September 31st 2024 infants born from October 1st 2023 to March 31st 2024 which are 6 to 1 month old at the time of immunization in April-June and the high-risk group defined as infants born with 29 weeks of gestational age wga or less who were born within nine months of the beginning of the RSV season those born with Bronchopulmonary Dysplasia BPD 32 or less wga andor a birth weight less than 15 kgs born within one year of the beginning of the RSV season and newborns 34 or less wga andor weight less than 25 kgs born during the RSV season
Nirsevimab will be administered as part of Chiles national immunization program following the implementation plan designed by the Ministry of Health The coverage with nirsevimab in the target population is expected to be high 95 for those born during the winter campaign and 80 for those born before the beginning of the autumn-winter season
The primary outcome measure for effectiveness will be lower-tract respiratory infection hospitalizations LRTI attributed to RSV in the pediatric intensive care units PICU at a nationwide and regional level and the secondary outcomes will be overall LRTI hospitalizations attributed to RSV LRTI hospitalizations and hospitalizations due to any cause Additional outcomes might be included if enough statistical power is attained
Effectiveness will be determined using a two-step process First historical data will be used to determine the set of ICD10 diagnosis codes that are attributable to RSV infection by using data from the Chilean national sentinel program and consolidated hospitalization records Afterward A series of complementary statistical analyses at different aggregation levels will be conducted to estimate the impact of nirsevimab on the target population Detailed patient-level information will be used to compare LRTI hospitalizations of those receiving the immunization against those who did not using an adjusted proportional hazard rates regression model to estimate the effectiveness of nirsevimab as a function of covariates such as wga weight at birth sex nationality maternal education coexisting conditions MMR vaccination as an indicator of access to medical care and place of birth This method has been used to evaluate recent nationwide vaccination campaigns in Chile Jara et al 2021 A case-control matching approach will be used as an alternative method intended to gain statistical efficiency Rose and van der Laan 2009 Finally as a robustness analysis a synthetic control method that allows the comparison of whole time series without relying on individual-level data will be used Bruhn et al 2016
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