A two-centre open-label non-inferiority trial to assess the immunogenicity and safety of an intradermal and an intramuscular single-visit dosing regimen of purified chick-embryo cell-culture rabies vaccine in adults

Conditions

Rabies

Brief summary

Difference in boostability on day 7 after the booster between the respective intervention groups and the standard of care group.

Detailed description

Percentage of subjects that have rabies antibodies ≥3.0 IU/ml on day 7 and day 28 after booster vaccination in all groups., Percentage of subjects that have rabies antibodies ≥10.0 IU/ml on day 7 and day 28 after booster vaccination in all groups., Percentage of subjects that have rabies antibodies ≥ 0.5 IU/ml on day 28 after pre-exposure vaccination in all groups, Percentage of subjects that have rabies antibodies ≥ 0.5 IU/ml at every visit for each regimen., Rabies serology slopes between the successive visits after the booster in all groups, Mean difference in antibody response between day of the booster and day 7, day 28, and day 90 after the booster., GMTs at all visits in all arms and the ratio between the GMTs in the intervention arms respectively and the standard of care arm.

Related papers

No related papers found yet.

Interventions

DRUGRabipur Pulver und Lösungsmittel zur Herstellung einer Injektionslösung in Fertigspritze Tollwutvirus (inaktiviert

DRUGStamm Flury LEP)

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Difference in boostability on day 7 after the booster between the respective intervention groups and the standard of care group.	—

Secondary

Measure	Time frame
Percentage of subjects that have rabies antibodies ≥3.0 IU/ml on day 7 and day 28 after booster vaccination in all groups., Percentage of subjects that have rabies antibodies ≥10.0 IU/ml on day 7 and day 28 after booster vaccination in all groups., Percentage of subjects that have rabies antibodies ≥ 0.5 IU/ml on day 28 after pre-exposure vaccination in all groups, Percentage of subjects that have rabies antibodies ≥ 0.5 IU/ml at every visit for each regimen., Rabies serology slopes between the successive visits after the booster in all groups, Mean difference in antibody response between day of the booster and day 7, day 28, and day 90 after the booster., GMTs at all visits in all arms and the ratio between the GMTs in the intervention arms respectively and the standard of care arm.	—

Measure

Time frame

Percentage of subjects that have rabies antibodies ≥3.0 IU/ml on day 7 and day 28 after booster vaccination in all groups., Percentage of subjects that have rabies antibodies ≥10.0 IU/ml on day 7 and day 28 after booster vaccination in all groups., Percentage of subjects that have rabies antibodies ≥ 0.5 IU/ml on day 28 after pre-exposure vaccination in all groups, Percentage of subjects that have rabies antibodies ≥ 0.5 IU/ml at every visit for each regimen., Rabies serology slopes between the successive visits after the booster in all groups, Mean difference in antibody response between day of the booster and day 7, day 28, and day 90 after the booster., GMTs at all visits in all arms and the ratio between the GMTs in the intervention arms respectively and the standard of care arm.

—

Countries

Belgium

Outcome results

None listed