A Phase 3, Randomized, Double-Blind, Active-Controlled, Confirmatory Study to Compare the Immunogenicity, Efficacy, and Safety of KD-414 Vaccine and Vaxzevria Vaccine in Adults Aged 18 to 40 Years Old (COVID-19)

Phase 3

Active, not recruiting

• Conditions: Prevention of COVID-19 infection

• Registration Number: JPRN-jRCT2031210679
• Lead Sponsor: Fushimi Hideki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

1. Is capable of understanding the written informed consent, provides signed informed consent, and agrees to comply with protocol requirements.
2. Is aged 18 to 40 years old.
3. Is healthy or medically stable as determined by investigator judgment based on medical history, physical examination, and vital signs. Medically stable condition is defined as any chronic medical disease or condition that has not required a change in medication or surgical intervention or resulted in hospitalization or medically attended events within 6 months prior to screening.

Exclusion Criteria

1. Has a current diagnosis or a history of laboratory confirmed SARS-CoV-2.
2. Has close contacts with person(s) with COVID-19 within 14 days of the first dose of study vaccine (based on the interview with subject).
3. Has been infected with HIV..
4. Has received any prior vaccines against COVID-19.
5. Has experienced documented anaphylaxis caused by an ingredient of study vaccine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Geometric mean titer of serum neutralizing antibody against SARS-CoV-2 at 28 days after the third dose of KD-414 (Day 148) as compared with that at 28 days after the second dose of Vaxzevria (Day 57).