Safety and efficacy of Monovalent and Bivalent Recombinant Protein Vaccines against COVID-19 in Adults 18 Years of Age and Older

Phase 3

• Registration Number: CTRI/2021/06/034442
• Lead Sponsor: Sanofi Healthcare India Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Aged 18 years or older on the day of inclusion.

2. For persons living with HIV, stable HIV infection determined by participant currently on antiretroviral with CD4 count more than 200/mm3.

3. SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies.

4. Does not intend to receive an authorized/approved COVID-19 vaccine despite encouragement by the Investigator.

5. A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:

•Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile.

OR

•Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 12 weeks after the second study intervention administration.

A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours before any dose of study intervention.

6. Informed consent form has been signed and dated.

7. Able to attend all visits and to comply with all study procedures.

8. Covered by health insurance, only if required by local, regional or national regulations

Exclusion Criteria

1. Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances.

2. Dementia or any other cognitive condition at a stage that could interfere with following the study procedures based on Investigatorâ??s judgment.

3. Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigatorâ??s judgment.

4. Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigatorâ??s judgment.

5. Unstable acute or chronic illness that in the opinion of the Investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures.

6. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature more than equal to 38.0°C [more than equal to 100.4°F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.

7. Receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention.

8. Prior administration of a coronavirus vaccine (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2], SARS-CoV, Middle East Respiratory Syndrome [MERS-CoV]).

9. Receipt of solid-organ or bone marrow transplants in the past 180 days.

10. Receipt of anti-cancer chemotherapy in the last 90 days.

11. Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.

12. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.

13. Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified