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
Brief Summary

The COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Currently, there are no licensed preventions available against COVID-19 and accelerated vaccine development is urgently needed. A safe and effective vaccine for COVID 19 prevention would have significant global public health impact.

Completed
COVID-19

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

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.

Eligibility Criteria

Inclusion Criteria:

- Participants aged 18 to 55 years (Cohort A and C), aged 56 to 69 years (Subcohorts B1
and D1), or aged ≥ 70 years (Subcohorts B2 and D2)

Exclusion Criteria:

1. Known past laboratory-confirmed SARS-CoV-2 infection

2. Positive SARS-CoV-2 RT PCR test at screening

3. Seropositivity to SARS-CoV-2 at screening.

4. Significant infection or other illness, including fever > 37.8°C on the day prior to
or day randomization

5. History of Guillain-Barré syndrome

6. Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia;
recurrent severe infections and use of immunosuppressant medication within the past 6
months, except topical steroids or short-term oral steroids (course lasting ≤ 14 days)

7. History of allergy to any component of the vaccine

8. Any history of angioedema

9. Any history of anaphylaxis

10. Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin
and uterine cervical carcinoma in situ)

11. History of serious psychiatric condition likely to affect participation in the study

12. Bleeding disorder (eg, factor deficiency, coagulopathy or platelet disorder), or prior
history of significant bleeding or bruising following IM injections or venepuncture

13. Suspected or known current alcohol or drug dependency

14. Any other significant disease, disorder or finding which may significantly increase
the risk to the participant because of participation in the study, affect the ability
of the participant to participate in the study or impair interpretation of the study
data

15. Severe and/or uncontrolled cardiovascular disease, respiratory disease,
gastrointestinal disease, liver disease, renal disease, endocrine disorder and
neurological illness (mild/moderate well controlled comorbidities are allowed)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Japan
Locations

Research Site
Fukuoka-shi, Japan

Research Site
Hachioji-shi, Japan

Research Site
Minato-ku, Japan

Research Site
Sumida-ku, Japan

Research Site
Toshima-ku, Japan

Iqvia Pty Ltd
NCT Number
Keywords
COVID-19 vaccine
MeSH Terms
COVID-19