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Clinical Trials/JPRN-jRCT2071200110
JPRN-jRCT2071200110
Completed
Phase 1

A Phase 1/2 study to assess the safety, immunogenicity and recommended dose of DS-5670a (COVID-19 Vaccine) in Japanese healthy adults and elderly subjects

Inoguchi Akihiro0 sites152 target enrollmentMarch 10, 2021
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ConditionsPrevention of COVID-19

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Prevention of COVID-19
Sponsor
Inoguchi Akihiro
Enrollment
152
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 10, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Inoguchi Akihiro

Eligibility Criteria

Inclusion Criteria

  • •1\) Japanese
  • •2\) Healthy adults aged \>\=20 and \<65 years, or healthy elderly aged \>\=65 and \<75 years (at the time of informed consent)
  • •3\) Body Mass Index (BMI) is \>\=17\.5 and \<30\.0 kg/m^2 (at screening )
  • •4\) Subjects who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc.

Exclusion Criteria

  • •1\) Having a history of anaphylaxis or severe allergies due to food, cosmetics, medicines, or vaccination.
  • •2\) Having alcohol or drug dependence.
  • •3\) Having a history of immunodeficiency or having a close relative with congenital immunodeficiency.
  • •4\) Having a history of SARS\-CoV\-2 infection.
  • •5\) Having fever of \>\=39\.0 C or symptoms of suspected allergies such as systemic rash within 2 days after past vaccination.

Outcomes

Primary Outcomes

Not specified

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