Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-29 @ 10:58 AM
Study NCT ID:
NCT04063150
Status:
TERMINATED
Last Update Posted:
2022-05-18
First Post:
2019-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity of Intramuscular and Intradermal IPV
Sponsor:
Centers for Disease Control and Prevention
Organization:
Study Overview
Official Title:
Immunogenicity of Intramuscular and Intradermal Inactivated Poliovirus Vaccine in Routine Immunization
Status:
TERMINATED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID-19 pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IM and ID IPV
Brief Summary:
This is an open-label phase IV randomized clinical trial that will compare immune responses among infants who receive different dose schedules of either fractional dose or full dose inactivated poliovirus vaccine (IPV), delivered either intramuscularly or intradermally.
Note: This study was terminated early due to the COVID-19 pandemic. Due to early study closure, the study objectives could not be evaluated as planned. Both of the primary objectives and several secondary objectives could not be evaluated because none of the study participants reached the corresponding endpoint. Due to limited sample size, the analysis approach for four secondary objectives was changed from a non-inferiority assessment to a comparison of proportions between groups.
Note: This study was terminated early due to the COVID-19 pandemic. Due to early study closure, the study objectives could not be evaluated as planned. Both of the primary objectives and several secondary objectives could not be evaluated because none of the study participants reached the corresponding endpoint. Due to limited sample size, the analysis approach for four secondary objectives was changed from a non-inferiority assessment to a comparison of proportions between groups.
Detailed Description:
Oral poliovirus vaccine (OPV) cessation is essential to achieve eradication of polio as OPV contains live poliovirus, which can mutate and become neurovirulent. After OPV cessation, inactivated poliovirus vaccine (IPV) will be the only polio vaccine used for routine immunization. This clinical trial will provide poliovirus type-specific immunogenicity data on an IPV or fractional-dose IPV (fIPV)-only schedule for routine immunization, which will be important for post OPV cessation era. For fIPV, it will provide immunogenicity data on fIPV administered either intradermally (ID) or intramuscularly (IM) and allow a direct comparison of the two methods.
Healthy infants 6 weeks of age will be enrolled at two study clinics in Dhaka, Bangladesh, and randomized to one of seven study arms. Infants will be followed-up until 10 months of age through clinic visits. Blood specimens will be collected to test for immunological response.
Healthy infants 6 weeks of age will be enrolled at two study clinics in Dhaka, Bangladesh, and randomized to one of seven study arms. Infants will be followed-up until 10 months of age through clinic visits. Blood specimens will be collected to test for immunological response.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: