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Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older (VAT00002)

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ClinicalTrials.gov Identifier: NCT04762680
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : August 26, 2021
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The primary objectives of the study are:

  • To assess the safety profile of the study vaccines in each study intervention group.
  • To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults.
  • To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a two-dose priming series with the monovalent vaccine, and superior to that observed immediately before booster.
  • To demonstrate that two doses of monovalent (B.1.351)-AS03 or bivalent (D614 + B.1.351)-AS03 SARS-CoV-2 vaccine induce an immune response that is non inferior to the response induced by monovalent (D614)-AS03 vaccine.

The secondary objectives of the study are:

  • To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study.
  • To assess the neutralizing and binding antibody responses of booster vaccination.
  • To describe the occurrences of laboratory-confirmed symptomatic COVID-19 after primary series and booster vaccination.
  • To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination.

Condition or disease Intervention/treatment Phase
COVID-19 (Healthy Volunteers) Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1 Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2 Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3 Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03, Dosage A Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03, Dosage A Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03, Dosage B Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03, Dosage B Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 1 Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 2 Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 3 Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 4 Phase 2 Phase 3

Detailed Description:

The duration of each participant's participation in the study will be approximately:

Original Phase 2 part: 365 days postinjection 2 (ie, 386 days total). Supplemental Cohorts 1 and 2: 365 days post-booster injection (ie, 366 days total).

Supplemental Cohort 3 and all Supplemental comparator groups: 365 days post-injection 2 (ie, 386 days total).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: To address the emergence of variant strains, Sanofi Pasteur is developing monovalent and bivalent vaccines for use as universal late booster and/or variant prime vaccines which will be studied in 3 additional Phase 3 study cohorts that are added to the initial Phase 2 protocol cohorts. Supplemental Cohorts 1 and 2 will evaluate booster vaccine candidates and supplemental Cohort 3 will evaluate priming immunization with variant-containing vaccines.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

In the original Phase 2 part, participants, outcome assessors, Investigators, laboratory personnel, and sponsor trial staff are blinded to intervention group; and those preparing the study interventions are unblinded to vaccine assignment group.

The supplemental Cohort 1 intervention group and Supplemental Cohort 1 and Cohort 2 comparator group will be open-label. Supplemental Cohort 2 will involve sequential randomization to main arms then exploratory arms, and the intervention will be modified double-blind (observer-blinded, as described). The supplemental Cohort 3 will also be modified double-blind.

Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccines With AS03 Adjuvant in Adults 18 Years of Age and Older as a Primary Series and Immunogenicity and Safety of a Booster Dose of SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (Two Monovalent and One Bivalent)
Actual Study Start Date : February 24, 2021
Estimated Primary Completion Date : December 24, 2022
Estimated Study Completion Date : December 24, 2022

Arm Intervention/treatment
Experimental: Phase 2 Cohort -SARS-CoV-2 vaccine Formulation 1
2 injections of SARS-CoV-2 vaccine Formulation 1 at Day 1 and Day 22
Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1
Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection

Experimental: Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 2
2 injections of SARS-CoV-2 vaccine Formulation 2 at Day 1 and Day 22
Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2
Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection

Experimental: Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 3
2 injections of SARS-CoV-2 vaccine Formulation 3 Day 1 and Day 22
Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3
Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection

Experimental: Supplemental Cohort 1 - Booster Monovalent (D614)-AS03 SARS-CoV-2 vaccine
Participants who were previously vaccinated 4 to < 10 months prior with an authorized mRNA or adenovirus-vector COVID-19 vaccine will receive 1 booster injection of monovalent (D614)-AS03 SARS-CoV-2 vaccine
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B
Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection

Experimental: Supplemental Cohort 2 - Booster Monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine
Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA or adenovirus-vector COVID-19 vaccine or SARS-Cov-2 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03, Dosage B
Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection

Experimental: Supplemental Cohort 2 - Booster Bivalent (D614 + B.1.351)-AS03 SARS-CoV-2 vaccine
Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA or adenovirus-vector COVID-19 vaccine or SARS-Cov-2 vaccine will receive 1 booster injection of bivalent (D614+B.1.351)-AS03 SARS-CoV-2 vaccine
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03, Dosage B
Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection

Experimental: Supplemental Cohort 2 - Booster Monovalent (D614)-AS03 SARS-CoV-2 vaccine
Participants who were vaccinated 4 to < 10 months prior with SARS-Cov-2 vaccine will receive 1 booster injection of monovalent (D614)-AS03 SARS-CoV-2 vaccine
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B
Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection

Active Comparator: Supplemental Comparator for Cohort 1 and 2 Boosters - Monovalent (D614)-AS03 SARS-CoV-2 vaccine
2 injections of monovalent (D614)-AS03 SARS-CoV-2 vaccine at Day 1 and Day 22 in previously unvaccinated, naïve participants
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A
Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection

Active Comparator: Supplemental Cohort 3 - Monovalent (D614)-AS03 SARS-CoV-2 vaccine
2 injections of monovalent (D614)-AS03 SARS-CoV-2 vaccine at Day 1 and Day 22 in previously unvaccinated, naïve participants
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A
Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection

Experimental: Supplemental Cohort 3 - Bivalent (D614 + B.1.351)-AS03 SARS-CoV-2 vaccine
2 injections of bivalent (D614+B.1.351)-AS03 SARS-CoV-2 vaccine at Day 1 and Day 22 in previously unvaccinated, naïve participants
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03, Dosage A
Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection

Experimental: Supplemental Cohort 3 - Monovalent (B.1.351)-AS03
2 injections of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine at Day 1 and Day 22 in previously unvaccinated, naïve participants
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03, Dosage A
Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection

Experimental: Cohort 2 - Booster Exploratory 1
Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 1
Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection

Experimental: Cohort 2 - Booster Exploratory 2
Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 2
Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection

Experimental: Cohort 2 - Booster Exploratory 3
Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 3
Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection

Experimental: Cohort 2 - Booster Exploratory 4
Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 4
Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection




Primary Outcome Measures :
  1. Presence of immediate adverse events [ Time Frame: Within 30 minutes after vaccination ]
    Immediate adverse events include unsolicited adverse events occurring within 30 minutes after injection.

  2. Presence of solicited injection site or systemic reactions [ Time Frame: Within 7 days after vaccination ]
    Injection site reactions: injection site pain, erythema and swelling. Systemic reactions: fever, headache, malaise and myalgia.

  3. Presence of unsolicited adverse events [ Time Frame: Within 21 days after vaccination ]
    Adverse events other than solicited reactions.

  4. Presence of serious adverse events [ Time Frame: From Day 1 to Day 387 ]
    Serious adverse events are reported throughout the study.

  5. Presence of adverse events of special interest [ Time Frame: From Day 1 to Day 387 ]
    Adverse events of special interest are reported throughout the study.

  6. Presence of medically-attended adverse events [ Time Frame: From Day 1 to Day 387 ]
    Medically-attended adverse events are new onset or a worsening of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department.

  7. Neutralizing antibody titer at Day 1 [ Time Frame: Day 1 ]
    Neutralizing antibody titers are expressed as geometric mean titers.

  8. Neutralizing antibody titer at Day 36 [ Time Frame: Day 36 ]
    Neutralizing antibody titers are expressed as geometric mean titers.

  9. Neutralizing antibody titer fold-rise post-vaccination [ Time Frame: From Day 1 to Day 36 ]
    Neutralizing antibody titer fold-rise post-vaccination.

  10. 2-fold rise and 4-fold-rise in neutralization antibody titer [ Time Frame: From Day 1 to Day 36 ]
    Fold-rise in antibody neutralization titer post-vaccination relative to Day 1.

  11. Responders, as determined by neutralizing antibody titers at Day 36 [ Time Frame: From Day 1 to Day 36 ]
    Responders, defined as participants who had baseline values below lower limit of quantification (LLOQ) with detectable neutralization titer above assay LLOQ at each pre-defined time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titer at Day 36

  12. Neutralizing antibody titer at Day 1 (pre-booster injection) [ Time Frame: Day 1 (pre-booster injection) ]
    Neutralizing antibody titers are expressed as geometric mean titers.

  13. Neutralizing antibody titer at Day 15 (post-booster injection) [ Time Frame: Day 15 (post-booster injection) ]
    Neutralizing antibody titers are expressed as geometric mean titers.

  14. Neutralizing antibody titer at Day 36 (Cohorts 1 and 2 Comparator Group and all Cohort 3 arms) [ Time Frame: Day 36 ]
    Neutralizing antibody titers are expressed as geometric mean titers.

  15. Responders, as determined by neutralizing antibody titers at Day 36 (Cohorts 1 and 2 Comparator Group and all Cohort 3 arms) [ Time Frame: From Day 1 to Day 36 ]
    Responders are defined as participants with a 4-fold-or greater rise in serum neutralization titer [pre/post] at Day 36 relative to Day 1


Secondary Outcome Measures :
  1. Neutralizing antibody titer at all pre-defined time points [ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]
  2. Neutralizing antibody titer fold-rise post-vaccination at all pre-defined time points [ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]
    Fold-rise in antibody neutralization titer post-vaccination relative to Day 1.

  3. Responders, as determined by neutralizing antibody titers at each pre-defined time point [ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]
    Responders, defined as participants who had baseline values below LLOQ with detectable neutralization titer above assay LLOQ at each pre-defined time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titer at each pre-defined timepoint.

  4. 2-fold rise and 4-fold-rise in neutralization antibody titer at all pre-defined time points [ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]
    Fold-rise in antibody neutralization titer post-vaccination relative to Day 1.

  5. Binding antibody fold-rise [ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]
    Fold-rise in concentration relative to Day 1.

  6. Binding antibody concentrations [ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]
  7. 2-fold-rise and 4-fold rise in binding antibody concentration [ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]
    Fold-rise in concentration relative to Day 1.

  8. Responders, as determined by binding antibody concentrations [ Time Frame: Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387 ]
    Responders are defined as participants who had baseline values below LLOQ with detectable anti concentration above assay LLOQ at each pre-defined time point and participants with baseline values above LLOQ with a 4-fold increase in anti-S antibody concentration at each pre-defined time point.

  9. Occurrences of laboratory-confirmed symptomatic COVID-19 [ Time Frame: From Day 1 to Day 387 ]
    Symptomatic COVID-19 is defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. Laboratory-confirmed SARS-CoV-2 infection is defined as a positive result for SARS CoV-2 by nucleic acid amplification test (NAAT), done by the central laboratory or locally, on at least one respiratory sample.

  10. Occurrences of symptomatic COVID-19 episodes associated with hospitalization [ Time Frame: From Day 1 to Day 387 ]
    Symptomatic COVID-19 is defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness.

  11. Occurrences of severe symptomatic COVID-19 [ Time Frame: From Day 1 to Day 387 ]
    Symptomatic COVID-19 is defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness with pre-defined criteria of severity.

  12. Occurrences of death associated with symptomatic COVID-19 [ Time Frame: From Day 1 to Day 387 ]
    Symptomatic COVID-19 is defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness.

  13. Occurrences of serologically-confirmed SARS-CoV-2 infection [ Time Frame: From Day 1 to Day 387 ]
    Serologically-confirmed SARS-CoV-2 infection is defined as a positive result in a serum sample for antibodies against SARS-CoV-2.

  14. Neutralizing antibody titer at all pre-defined time points post-booster and booster comparator injection [ Time Frame: Day 1 and Day 15 (post-booster injection) and Day 36 ]
  15. Neutralizing antibody titer fold-rise post-vaccination at all pre-defined time points post-booster and booster comparator injection [ Time Frame: Day 1 and Day 15 (post-booster injection) and Day 36 ]
    Neutralizing antibody titer fold-rise post-vaccination.

  16. 2-fold rise and 4-fold-rise in neutralization antibody titer at all pre-defined time points post-booster and booster comparator injection [ Time Frame: Day 1 and Day 15 -post-booster injection) and Day 36 ]
    Neutralizing antibody titer fold-rise post-vaccination.

  17. Seroresponse rate post-booster and booster comparator injection [ Time Frame: Day 1 and Day 15 (post-booster injection) and Day 36 ]
    Seroresponse rate is defined as the percentage or participants with 4-fold-or greater rise in serum neutralization titer [pre/post] at post-vaccination relative to pre-vaccination.

  18. Binding antibody concentrations post-booster injection [ Time Frame: Day 1, Day 15, Day 29, Day 91, Day 181, and Day 366 (post-booster injection) ]
  19. Binding antibody fold-rise post-booster injection [ Time Frame: Day 1, Day 15, Day 29, Day 91, Day 181, and Day 366 (post-booster injection) ]
    Fold-rise in concentration relative to Day 1.

  20. 2-fold-rise and 4-fold rise in binding antibody concentration post-booster injection [ Time Frame: Day 1, Day 15, Day 29, Day 91, Day 181, and Day 366 (post-booster injection) ]
    Fold-rise in concentration relative to Day 1.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18 years or older on the day of inclusion.
  • 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 mut 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 vaccination until at least 12 weeks after the second vaccination. A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 4 hours before any dose of study intervention.

  • Informed consent form has been signed and dated.
  • Able to attend all scheduled visits and to comply with all study procedures.
  • SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies (Original Phase 2 Cohort).
  • For persons living with human immunodeficiency virus (HIV), stable HIV infection determined by participant currently on antiretrovirals with CD4 count > 200/mm3.
  • Does not intend to receive an authorized/approved COVID-19 vaccine from first vaccination to 3 weeks after the second vaccination despite encouragement by the investigator to receive the authorized vaccine available to them at the time of enrollment.
  • Supplemental cohorts: for participants originally enrolled in the Phase II cohort of the study, informed consent has to be signed and dated for transitioning to Supplemental Cohort 2.
  • Supplemental cohorts, booster arms: received a complete primary vaccination series with an authorized/conditionally approved mRNA COVID-19 vaccine (mRNA-1273 [Moderna] or BNT162b2 [Pfizer/BioNTech]) or adenovirus-vectored COVID-19 vaccine (ChAdOx1 nCoV-19 [Oxford University/AstraZeneca] or Ad26.CoV2.S [J&J/Janssen]), with the last dose administered a minimum of 4 months prior to inclusion but not longer than 10 months prior to inclusion.

Exclusion Criteria:

  • 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.
  • Dementia or any other cognitive condition at a stage that could interfere with following the trial procedures based on Investigator or designee's judgment.
  • Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator's judgment.
  • Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator's judgment.
  • 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.
  • Receipt of solid-organ or bone marrow transplants in the past 180 days.
  • Receipt of anti-cancer chemotherapy in the last 90 days.
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]). A prospective participant should not be included in the trial until the condition has resolved or the febrile event has subsided.
  • 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.
  • Applicable to Original Phase II Cohort, Supplemental Cohort 1 and Cohort 2 Comparator Group, and Supplemental Variant Prime Cohort 3 Groups: Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome [MERS-CoV]).
  • Participation at the time of trial enrollment (or in the 30 days preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
  • Exclusion criterion for the Supplemental Cohort 1 and Cohort 2 comparator group and for the 3 Supplemental Variant Prime Cohort 3 groups: positive rapid diagnostic test for SARS-CoV-2 antibodies at time of enrollment.
  • Exclusion criterion for participants in Supplemental Cohort 2 who were primed as participant in the Original Phase II Cohort of the present study): Receipt of authorized/conditionally approved COVID-19 vaccine after enrollment in Original Phase 2 Cohort.
  • Exclusion criterion for all Booster groups: Documented virologically-confirmed SARS-CoV-2 infection (by NAAT) after first dose of primary immunization.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04762680


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
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Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
GlaxoSmithKline
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT04762680    
Other Study ID Numbers: VAT00002
U1111-1251-4616 ( Registry Identifier: ICTRP )
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs