A Randomized, Active-comparator, Observer-blind, Phase I/II/III Study to Demonstrate the Immunogenicity of a Single Booster Dose of DS-5670a in Adults and Elderly Received a Primary Series of Approved COVID-19 Vaccine
- Conditions
- Prevention of infectious disease by SARS-CoV-2
- Registration Number
- JPRN-jRCT2071210106
- Lead Sponsor
- Inoguchi Akihiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 5028
1)Adults aged 18 to 64 years at the time of consent, or elderly subjects aged 65 years or older at the time of consent.
2)Subjects who had received the 2nd dose of the initial series of SARS-CoV-2 vaccines (either Comirnaty or Spikevax[previously Moderna]) at least 6 months prior to signing consent.
1)Subjects who have a history of seizure or epilepsy after vaccination.
2)Subjects who have had symptoms of SARS-CoV-2 infection and been diagnosed with SARS-CoV-2 infection by reverse transcription polymerase chain reaction (RT-PCR) test, SARS-CoV-2 antigen test, or SARS-CoV-2 antibody test in the past.
3)Subjects who have suggestive symptoms of SARS-CoV-2 infection (respiratory symptoms, headache, malaise, olfactory dysfunction, or taste disorder, etc.) at the time of consent.
4)Subjects who have a positive SARS-CoV-2 antigen test or SARSCoV-2 antibody test at the time of eligibility assessment.
5)Subjects who have a history of anaphylaxis or severe allergy to food, pharmaceuticals, cosmetics, vaccination, etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method