Study of AZD1222 for the Prevention of COVID-19 in Japan
Study identifier:D8111C00002
ClinicalTrials.gov identifier:NCT04568031
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I/II Randomized, Double-blind, Placebo-controlled Multicentre Study in Participants Aged 18 Years or Older to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19
Medical condition
COVID-19
Phase
Phase 1/2
Healthy volunteers
Yes
Study drug
AZD1222, 0.9% (w/v) saline
Sex
All
Actual Enrollment
256
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 23 Aug 2020
Primary Completion Date: 22 Nov 2021
Study Completion Date: 22 Nov 2021
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Prevention
Verification:
Verified 01 Jul 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
IQVIA
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Part I Cohort C will include healthy participants aged 18 to 55 years. Cohort D will include healthy elderly participants aged ≥ 56 years. In Cohort D, the elderly population is further divided into 2 different age subgroups; aged 56 to 69 years (Subcohort D1) and aged ≥ 70 years (Subcohort D2). At least 30% of participants in Cohort D will be secured for participants with age ≥ 70 years. | Drug: AZD1222 For subjects in part 1 will have that route of Administration as Intramuscular, 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) on V2 |
| Placebo Comparator: Part II Cohort C will include healthy participants aged 18 to 55 years. Cohort D will include healthy elderly participants aged ≥ 56 years. In Cohort D, the elderly population is further divided into 2 different age subgroups; aged 56 to 69 years (Subcohort D1) and aged ≥ 70 years (Subcohort D2). At least 30% of participants in Cohort D will be secured for participants with age ≥ 70 years. | Drug: 0.9% (w/v) saline For subjects in placebo will have that route of Administration as Intramuscular 0.9% (w/v) saline on V2 and V6. |
