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Trial - NCT04821674


Column Value
Trial registration number NCT04821674
Full text link
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04821674

First author
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Daiichi Sankyo Contact for Clinical Trial Information

Contact
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

dsclinicaltrial@daiichisankyo.co.jp

Registration date
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-03-29

Recruitment status
Last imported at : Sept. 1, 2022, 10 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - japanese citizen - healthy adults aged ≥20 and <65 years, or healthy elderly aged ≥65 and <75 years (at the time of informed consent) - body mass index (bmi) is ≥17.5 and <30.0 kg/m^2 (at screening) - participants who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc.

Exclusion criteria
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- have a history of immunodeficiency or having a close relative with congenital immunodeficiency. - have a history of sars-cov-2 infection. - have previously participated in an investigational study of sars-cov-2 vaccine or involving lnps. - have a history of anaphylaxis or severe allergies due to food, cosmetics, medicines, or vaccination - have alcohol or drug dependence. - have a fever of ≥39.0°c or symptoms of suspected allergies such as systemic rash within 2 days after past vaccination, etc.

Number of arms
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

5

Funding
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Daiichi Sankyo Co., Ltd.

Inclusion age min
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

20

Inclusion age max
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

74

Countries
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Japan

Type of patients
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Sept. 1, 2022, 10 p.m.
Source : ClinicalTrials.gov

142

primary outcome
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific Neutralizing Antibody;Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody;Number of Participants Reporting Local and Systemic Adverse Events;Number of Participants Reporting Serious Events;Number of Participants Reporting Treatment-emergent Adverse Events;Seroconversion Rates of SARS-CoV-2 Specific Neutralizing Antibody

Notes
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Phase 1/Phase 2

Arms
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "10 \u00b5g;1; \u226520 and <65 years and \u226565 and <75 years", "treatment_id": 422, "treatment_name": "Ds-5670a", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30 \u00b5g;1; \u226520 and <65 years and \u226565 and <75 years", "treatment_id": 422, "treatment_name": "Ds-5670a", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "60 \u00b5g;1; \u226520 and <65 years and \u226565 and <75 years", "treatment_id": 422, "treatment_name": "Ds-5670a", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "100 \u00b5g;1; \u226520 and <65 years and \u226565 and <75 years", "treatment_id": 422, "treatment_name": "Ds-5670a", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]