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CTRI Number  CTRI/2021/06/034442 [Registered on: 29/06/2021] Trial Registered Prospectively
Last Modified On: 28/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Other 
Public Title of Study   Safety and efficacy of Monovalent and Bivalent Recombinant Protein Vaccines against COVID-19 in Adults 18 Years of Age and Older 
Scientific Title of Study   A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older 
Secondary IDs if Any  
Secondary ID  Registry 
23143  Other 
U1111-1264-3238  UTN 
VAT00008 version No. 2.0 dated 16 Apr 2021  Protocol Number 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  

Details Contact Person
Scientific Query
Name  Dr Somnath Mangarule 
Address  4th Floor Vasantha Chambers Fateh Maidan Road Basheer Bagh Hyderabad

Phone  04066301502  
Email  Somnath.Mangarule@sanofi.com  
Details Contact Person
Public Query
Name  Dr Somnath Mangarule 
Address  4th Floor Vasantha Chambers Fateh Maidan Road Basheer Bagh Hyderabad

Phone  04066301502  
Email  Somnath.Mangarule@sanofi.com  
Source of Monetary or Material Support  
Sanofi Pasteur Inc Discovery Drive, Swiftwater, PA 18370-0187, USA 
Primary Sponsor  
Name  Sanofi Healthcare India Private Limited 
Address  Sanofi House, CTS No.117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai 400 072, India 
Type of Sponsor  Pharmaceutical industry-Global 
Details of Secondary Sponsor  
Name  Address 
Countries of Recruitment     Colombia
Dominican Republic
Sri Lanka
United States of America  
Sites of Study
No of Sites = 10  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Jinen Shah  Aartham Multi Super Speciality Hospital  Opp. Polytechnic, NR Panjrapol cross road, Ambawadi, Ahmedabad 380015, Gujarat, India

Dr Chandramani Singh  All India Institute of Medical Science (AIIMS)  Dept. of Community and Family Medicine Phulwarisharif, Patna, Bihar- 801507, India

Dr Chandan Das  Institute of Medical Sciences (IMS) & SUM Hospital  K8, Kalinga Nagar, Ghatikia, Bhubaneswar-751003, Odisha, India

Dr Veer Bahadur Singh  Jawahar Lal Nehru Medical College  Kala Bagh, Ajmer – 305001, Rajasthan

Dr Amit Suresh Bhate  Jeevan Rekha Hospital  Dr. B R Ambedkar Road Belagavi- 590002

Dr Manish Kumar Jain  Maharaja Agrasen Supe speciality Hospital  Central Spine, Agrasen Aspatal Marg Sector 7, Vidhyadhar Nagar, Jaipur, Rajasthan – 302039, India

Dr Chinthaparthi Prabhakar Reddy  Nizam’s Institute of Medical Sciences  Department of Clinical Pharmacology & Therapeutics, Panjagutta Hyderabad Telangana - 500082 India

Dr JS Kushwaha  Prakhar Hospital Private Ltd  8/219 Arya Nagar, Kanpur – 208002, UP India
Kanpur Nagar

Dr Satyajit Mohapatra  SRM Medical College Hospital & Research Centre  SRM Nagar,Potheri, Tamil Nadu, 603211-India

Dr Nitin Khandelwal  Vidarbha Institute of Medical Sciences  Kamptee Rd, LIC Square, Mohan Nagar, Nagpur, Maharashtra 440001

Details of Ethics Committee
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Aartham Ethics Committee_Dr. Jinen Shah  Approved 
Ethics Committee of Prakhar Hospital_Dr. JS Kushwaha  Approved 
IEC, Maharaja Agrasen Hospital_Dr. Manish Kumar Jain  Approved 
IEC_AIIMS Patna_Dr. Chandramani Singh  Approved 
IEC_IMS and SUM Hospital_Dr. Chandan Das  Approved 
IEC_Jeevan Rekha Hospital_Dr. Amit Suresh Bhate  Approved 
IEC_JLN Medical College_Dr. Veer Bahadur Singh  Approved 
IEC_SRM Medical College Hospital and Research Centre_Dr. Satyajit Mohapatra  Approved 
IEC_Vidharbha Institute of Medical Sciences_Dr. Nitin Khandelwal  Approved 
NIMS Institutional Ethics Committee_Dr. CP Reddy  Approved 
Regulatory Clearance Status from DCGI
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  COVID 19 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bivalent Vaccine  Recombinant adjuvanted COVID-19 bivalent vaccine [CoV2 PreS dTM ASO3 bivalent vaccine (D614 +B.1.351)] will be administered as two dose series at D01 and D22 in STAGE 2 Participants, by IM route 
Intervention  Monovalent vaccine  Recombinant adjuvanted COVID-19 monovalent vaccine [CoV2 PreS dTM ASO3 monovalent vaccine (D614)] will be administered as two dose series at D01 and D22 in STAGE 1 Participants, by IM route 
Comparator Agent  Placebo  0.9% normal saline placebo will be administered as two dose series at D01 and D22 in STAGE 1 and 2 Participants, by IM route 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  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.
•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 
Details  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 Investigator’s judgment.
3. Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator’s judgment.
4. Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator’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. 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Efficacy: Occurrences of symptomatic COVID-19

Safety: To assess the safety of the CoV2 preS dTM-AS03 vaccines compared to placebo 
More than equals to 14 days after the second injection 
Secondary Outcome  
Outcome  TimePoints 
Key Secondary Efficacy:
•Occurrences of SARS-CoV-2 infection
•Occurrence of severe COVID-19
Key Immunogenicity:
To compare the neutralizing antibody response 21 days after last vaccination (D43) to the D614G variant and B.1.351 variant between the monovalent and bivalent vaccines in SARS-CoV-2 naïve and non-naïve participants in the Random Immunogenicity Subcohort. 
More that equals to 14 days after the second injection 
Target Sample Size   Total Sample Size="37430"
Sample Size from India="3000" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   06/07/2021 
Date of First Enrollment (Global)  26/05/2021 
Estimated Duration of Trial   Years="1"
Recruitment Status of Trial (Global)
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Brief Summary  

Background: In the VAT00008 efficacy study, the antigen dose for both the monovalent and bivalent vaccines was determined based on safety and immunogenicity data observed in the VAT00002 Phase II study, results of nonclinical studies, and information on manufacturing capacity. The interim data from the VAT00002 study were used to select the 10 µg dose for the monovalent D614 vaccine to be tested in Stage 1 of the Phase III study; and for Stage 2 of the Phase III study with the bivalent D614 + B.1.351 vaccine, a 5 µg (D614 component) + 5 µg (B.1.351 component) antigen dose was selected.

Purpose: This Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) in adults 18 years of age and older in a multi-stage approach.

Summary: VAT00008 will be a Phase III, randomized, modified double-blind, placebo-controlled, multi-stage, multi‑center, multi-country study to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older