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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04762680




Registration number
NCT04762680
Ethics application status
Date submitted
18/02/2021
Date registered
21/02/2021
Date last updated
28/06/2024

Titles & IDs
Public title
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
Scientific 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)
Secondary ID [1] 0 0
U1111-1251-4616
Secondary ID [2] 0 0
VAT00002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1
Treatment: Other - SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2
Treatment: Other - SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3
Treatment: Other - SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A
Treatment: Other - SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03
Treatment: Other - SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B
Treatment: Other - SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 1
Treatment: Other - SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 2
Treatment: Other - SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 3
Treatment: Other - SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 4
Treatment: Other - SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03

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

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

Experimental: Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 3 - 2 injections of SARS-CoV-2 vaccine Formulation 3 Day 1 and Day 22

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

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

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 will receive 1 booster injection of bivalent (D614+B.1.351)-AS03 SARS-CoV-2 vaccine

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

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

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

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

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

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


Treatment: Other: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Treatment: Other: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Treatment: Other: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Treatment: Other: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Treatment: Other: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Treatment: Other: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Treatment: Other: 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

Treatment: Other: 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

Treatment: Other: 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

Treatment: Other: 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

Treatment: Other: SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of immediate adverse events
Timepoint [1] 0 0
Within 30 minutes after vaccination
Primary outcome [2] 0 0
Presence of solicited injection site or systemic reactions
Timepoint [2] 0 0
Within 7 days after vaccination
Primary outcome [3] 0 0
Presence of unsolicited adverse events
Timepoint [3] 0 0
Within 21 days after vaccination
Primary outcome [4] 0 0
Presence of serious adverse events
Timepoint [4] 0 0
From Day 1 to Day 387
Primary outcome [5] 0 0
Presence of adverse events of special interest
Timepoint [5] 0 0
From Day 1 to Day 387
Primary outcome [6] 0 0
Presence of medically-attended adverse events
Timepoint [6] 0 0
From Day 1 to Day 387
Primary outcome [7] 0 0
Neutralizing antibody titer at Day 1
Timepoint [7] 0 0
Day 1
Primary outcome [8] 0 0
Neutralizing antibody titer at Day 36
Timepoint [8] 0 0
Day 36
Primary outcome [9] 0 0
Neutralizing antibody titer fold-rise post-vaccination
Timepoint [9] 0 0
From Day 1 to Day 36
Primary outcome [10] 0 0
2-fold rise and 4-fold-rise in neutralization antibody titer
Timepoint [10] 0 0
From Day 1 to Day 36
Primary outcome [11] 0 0
Responders, as determined by neutralizing antibody titers at Day 36
Timepoint [11] 0 0
From Day 1 to Day 36
Primary outcome [12] 0 0
Neutralizing antibody titer at Day 1 (pre-booster injection)
Timepoint [12] 0 0
Day 1 (pre-booster injection)
Primary outcome [13] 0 0
Neutralizing antibody titer at Day 15 (post-booster injection)
Timepoint [13] 0 0
Day 15 (post-booster injection)
Primary outcome [14] 0 0
Neutralizing antibody titer at Day 36 (Cohorts 1 and 2 Comparator Group)
Timepoint [14] 0 0
Day 36
Primary outcome [15] 0 0
Responders, as determined by neutralizing antibody titers at Day 36 (Cohorts 1 and 2 Comparator Group)
Timepoint [15] 0 0
From Day 1 to Day 36
Secondary outcome [1] 0 0
Neutralizing antibody titer at all pre-defined time points
Timepoint [1] 0 0
Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387
Secondary outcome [2] 0 0
Neutralizing antibody titer fold-rise post-vaccination at all pre-defined time points
Timepoint [2] 0 0
Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387
Secondary outcome [3] 0 0
Responders, as determined by neutralizing antibody titers at each pre-defined time point
Timepoint [3] 0 0
Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387
Secondary outcome [4] 0 0
2-fold rise and 4-fold-rise in neutralization antibody titer at all pre-defined time points
Timepoint [4] 0 0
Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387
Secondary outcome [5] 0 0
Binding antibody fold-rise
Timepoint [5] 0 0
Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387
Secondary outcome [6] 0 0
Binding antibody concentrations
Timepoint [6] 0 0
Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387
Secondary outcome [7] 0 0
2-fold-rise and 4-fold rise in binding antibody concentration
Timepoint [7] 0 0
Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387
Secondary outcome [8] 0 0
Responders, as determined by binding antibody concentrations
Timepoint [8] 0 0
Day 1, Day 22, Day 36, Day 78, Day 134, Day 202, Day 292 and Day 387
Secondary outcome [9] 0 0
Occurrences of laboratory-confirmed symptomatic COVID-19
Timepoint [9] 0 0
From Day 1 to Day 387
Secondary outcome [10] 0 0
Occurrences of symptomatic COVID-19 episodes associated with hospitalization
Timepoint [10] 0 0
From Day 1 to Day 387
Secondary outcome [11] 0 0
Occurrences of severe symptomatic COVID-19
Timepoint [11] 0 0
From Day 1 to Day 387
Secondary outcome [12] 0 0
Occurrences of death associated with symptomatic COVID-19
Timepoint [12] 0 0
From Day 1 to Day 387
Secondary outcome [13] 0 0
Occurrences of serologically-confirmed SARS-CoV-2 infection
Timepoint [13] 0 0
From Day 1 to Day 387
Secondary outcome [14] 0 0
Neutralizing antibody titer at all pre-defined time points post-booster and booster comparator injection
Timepoint [14] 0 0
Day 1 and Day 15 (post-booster injection) and Day 36
Secondary outcome [15] 0 0
Neutralizing antibody titer fold-rise post-vaccination at all pre-defined time points post-booster and booster comparator injection
Timepoint [15] 0 0
Day 1 and Day 15 (post-booster injection) and Day 36
Secondary outcome [16] 0 0
2-fold rise and 4-fold-rise in neutralization antibody titer at all pre-defined time points post-booster and booster comparator injection
Timepoint [16] 0 0
Day 1 and Day 15 -post-booster injection) and Day 36
Secondary outcome [17] 0 0
Seroresponse rate post-booster and booster comparator injection
Timepoint [17] 0 0
Day 1 and Day 15 (post-booster injection) and Day 36
Secondary outcome [18] 0 0
Binding antibody concentrations post-booster injection
Timepoint [18] 0 0
Day 1, Day 15, Day 29, Day 91, Day 181, and Day 366 (post-booster injection)
Secondary outcome [19] 0 0
Binding antibody fold-rise post-booster injection
Timepoint [19] 0 0
Day 1, Day 15, Day 29, Day 91, Day 181, and Day 366 (post-booster injection)
Secondary outcome [20] 0 0
2-fold-rise and 4-fold rise in binding antibody concentration post-booster injection
Timepoint [20] 0 0
Day 1, Day 15, Day 29, Day 91, Day 181, and Day 366 (post-booster injection)

Eligibility
Key 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 last vaccination (ie, second dose of primary series or booster injection). 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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. Receipt of immunoglobulins, blood, or blood-derived products in the past 3 months.

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: Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome [MERS-CoV]). Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study trial period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Exclusion criterion for the Supplemental Cohort 1 and Cohort 2 comparator group: 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/06/2023
Sample size
Target
Accrual to date
Final
3385
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Investigational Site Number : 0360001 - South Brisbane
Recruitment hospital [2] 0 0
Investigational Site Number : 0360003 - Norwood
Recruitment hospital [3] 0 0
Investigational Site Number : 0360002 - Southport
Recruitment hospital [4] 0 0
Investigational Site Number : 0360005 - Westmead
Recruitment hospital [5] 0 0
Investigational Site Number : 0360004 - Woodville
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
5067 - Norwood
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
South Dakota
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
France
State/province [22] 0 0
Dijon
Country [23] 0 0
France
State/province [23] 0 0
Limoges
Country [24] 0 0
France
State/province [24] 0 0
Lyon
Country [25] 0 0
France
State/province [25] 0 0
Marseille
Country [26] 0 0
France
State/province [26] 0 0
Nantes
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
France
State/province [28] 0 0
Pessac
Country [29] 0 0
France
State/province [29] 0 0
Pierre Benite
Country [30] 0 0
France
State/province [30] 0 0
Rennes
Country [31] 0 0
France
State/province [31] 0 0
Tours Cedex 1
Country [32] 0 0
Honduras
State/province [32] 0 0
Municipio Del Distrito Central
Country [33] 0 0
Honduras
State/province [33] 0 0
San Pedro Sula
Country [34] 0 0
New Zealand
State/province [34] 0 0
Auckland
Country [35] 0 0
New Zealand
State/province [35] 0 0
Christchurch
Country [36] 0 0
New Zealand
State/province [36] 0 0
Nawton
Country [37] 0 0
New Zealand
State/province [37] 0 0
Nelson
Country [38] 0 0
New Zealand
State/province [38] 0 0
Rotorua
Country [39] 0 0
Spain
State/province [39] 0 0
Galicia [Galicia]
Country [40] 0 0
Spain
State/province [40] 0 0
Madrid
Country [41] 0 0
Spain
State/province [41] 0 0
Valencia
Country [42] 0 0
Spain
State/province [42] 0 0
Vigo
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Halton
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Somerset
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Sutton
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Doncaster
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Gloucester
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Harrow
Country [49] 0 0
United Kingdom
State/province [49] 0 0
London
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi Pasteur, a Sanofi Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
GlaxoSmithKline
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 twodose priming series with the monovalent vaccine, and superior to that observed immediately before booster.

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 COVID19 after primary series and booster vaccination.

To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination.
Trial website
https://clinicaltrials.gov/study/NCT04762680
Trial related presentations / publications
Sridhar S, Joaquin A, Bonaparte MI, Bueso A, Chabanon AL, Chen A, Chicz RM, Diemert D, Essink BJ, Fu B, Grunenberg NA, Janosczyk H, Keefer MC, Rivera M DM, Meng Y, Michael NL, Munsiff SS, Ogbuagu O, Raabe VN, Severance R, Rivas E, Romanyak N, Rouphael NG, Schuerman L, Sher LD, Walsh SR, White J, von Barbier D, de Bruyn G, Canter R, Grillet MH, Keshtkar-Jahromi M, Koutsoukos M, Lopez D, Masotti R, Mendoza S, Moreau C, Ceregido MA, Ramirez S, Said A, Tavares-Da-Silva F, Shi J, Tong T, Treanor J, Diazgranados CA, Savarino S. Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study. Lancet Infect Dis. 2022 May;22(5):636-648. doi: 10.1016/S1473-3099(21)00764-7. Epub 2022 Jan 25.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04762680