AstraZeneca Vax – Sputnik V Combination Study

Exclusion Criteria

• Medical Conditions
• 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 of randomisation
• 5 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).
• 6 History of allergy to any component of the vaccine
• 7 Any history of anaphylaxis or angioedema.
• 8 Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and uterine cervical carcinoma in situ).
• 9 History of serious psychiatric condition likely to affect participation in the study.
• 10 Bleeding disorder (eg, factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
• 11 Suspected or known current alcohol or drug dependency.
• 12 History of Guillan-Barré syndrome or any other demyelinating condition.
• 13 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.
• 14 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).
• Prior/Concomitant Therapy
• 15 Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination.
• 16 Prior or planned receipt of an investigational or licensed vaccine or product likely to impact on interpretation of the trial data (eg, adenovirus vectored vaccines, any coronavirus vaccines).
• 17 Administration of immunoglobulins and/or any blood products within the 3 months preceding the planned administration of the vaccine candidate.
• 18 Continuous use of anticoagulants, such as coumarins and related anticoagulants (ie, warfarin) or novel oral anticoagulants (ie, apixaban, rivaroxaban, dabigatran and edoxaban).
• Prior/Concurrent Clinical Study Experience
• 19 Participation in COVID-19 prophylactic drug trials for the duration of the study.
• Other Exclusions
• 20 For female subjects only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.