Immunogenicity of Intramuscular and Intradermal IPV

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.

Timeline

Start

2019-10-06

Primary completion

2020-03-25

Completion

2020-03-25

Outcome

Outcome not reported

Stopped: “COVID-19 pandemic”

Drugs

Indications