jRCT2031230340CompletedNot Applicable
A randomized, controlled, blinded study of ARCT-2301 as booster in healthy adults in Japan (Phase III)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Meiji Seika Pharma Co.,Ltd.
- Enrollment
- 850
- Primary Endpoint
- Geometric mean titer (GMT)
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Double Blind
Eligibility Criteria
- Ages
- 18age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •Individuals are participant (irrespective of gender) >=18 years of age at Informed consent.
- •Participant or legally authorized representatives must freely provide documented informed consent prior to study procedures being performed.
- •Individuals must have been previously vaccinated with mRNA COVID-19 vaccine and satisfy the following criteria.
- •Received 2~4 doses with authorized mRNA COVID-19 vaccine (monovalent COMIRNATY or monovalent SPIKEVAX)
- •Received the last booster dose of COMIRNATY RTU intramuscular injection ([bivalent: Wuhan strain/Omicron BA.1] or [bivalent: Wuhan strain/Omicron BA.4/5])
- •At least 3 months have passed since the last vaccination at the time of screening
- •Receipt of these vaccines is supported by any documents and application software
Exclusion Criteria
- •Individuals with acute medical illness or febrile illness, including oral temperature >= 37.5 degree Celsius within 1 day prior to Screening. These individuals may be offered the opportunity to enter the study after fever and illness has stabilized. Participants with suspected or confirmed COVID-19 should be excluded and referred for medical care. Rescreening will be permitted for individuals who presented with suspected COVID-19 if another cause is confirmed.
- •Individuals with a positive SARS-CoV-2 rapid antigen test at Screening
- •Individuals with a history of COVID-19 with ongoing sequelae of COVID-19 infection within 6 months
Outcomes
Primary Outcomes
Geometric mean titer (GMT)
Time Frame: Day 29
Geometric mean titer of neutralizing antibodies against SARS-CoV-2 (Omicron strain BA.4-5)
Seroresponse rate (SRR)
Time Frame: Day 29
Seroresponse rate of neutralizing antibodies against SARS-CoV-2 (Omicron strain BA.4-5)
Secondary Outcomes
No secondary outcomes reported
Investigators
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