Comparison with subcutaneous injections using a needle-free injection system

Takazawa Kenji0 sites40 target enrollmentApril 22, 2022

Overview

No summary available.

Registry

who.int

Start Date

April 22, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Takazawa Kenji

•1\)Men and women between the age of 20 and 40 at the time of obtaining informed consent
•2\)Those who can obtain document informed consent from the person in question
•3\)Those who have a wind shin antibody titer (HI method) of less than 1:32 at the time of screening test
•4\)Those who are able to observe compliance items during participation in this clinical research, receive medical examinations and examinations stipulated in this research plan, and declare symptoms, etc.
•5\)Those who have been judged to be eligible as subject of this clinical research by research responsibility (sharing) doctor in consideration of the results of the screening test.

•1\)Those who have or have a history of hypersensitivity or specific constitution to drugs that have presented anaphylaxis by food or medicine in the past
•2\)Pregnant women, breastfeeding and those who have the possibility or intention of pregnancy, and those who cannot agree to contraception from obtaining consent until 6 to 8 weeks (Visit 3\) after inoculation regardless of gender.
•3\)Those who have a clear fever
•4\)Those who are clearly involved in severe acute diseases
•5\)Those who have been found to have anaphylaxis dependent on the ingredients of the research drug used.
•6\)Those who have a disease with clearly abnormal immune function or who are receiving treatment for immune\- suppression
•7\)Those who are prone to bleeding or who are using blood clotting inhibitors.
•8\)Those who are extremely slim (BMI 16\.0 or less)
•9\)Those who have been vaccinated with a vaccine containing a rubella vaccine, a measles vaccine, or both active ingredients at least 12 years of age.
•10\) Those who have a history of suffering from measles