Other substances

SCB-2019

COVID-19 candidate vaccine

Phase of research

Potential treatment - pre-clinical evidence

How it helps

Vaccine

Drug status

Experimental

1
 Supporting references
0
 Contradictory references
4
 AI-suggested references
9
 Clinical trials

General information

SCB-2019 is a COVID-19 candidate vaccine being developed by Clover Biopharmaceuticals Inc./GSK/Dynavax. It is a native-like trimeric subunit Spike Protein type of candidate vaccine. It is based on the Protein Subunit platform, which is also used for non-COVID-19 candidates, such as HIV, REV, and Influenza. Currently, this COVID-19 candidate vaccine is in Phase I clinical evaluation.

 

Supporting references

Link Tested on Impact factor Notes Publication date
DRAFT landscape of COVID-19 candidate vaccines – 26 March 2020
in vitro Mar/26/2020

AI-suggested references

Link Publication date
Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, placebo-controlled trial
Jul/13/2021
Immunogenicity of SCB-2019 Coronavirus Disease 2019 Vaccine Compared With 4 Approved Vaccines
Nov/12/2021
Persistence of the Immune Responses and Cross-Neutralizing Activity With Variants of Concern Following 2 Doses of Adjuvanted SCB-2019 Coronavirus Disease 2019 Vaccine
May/30/2020
Efficacy of the adjuvanted subunit protein COVID-19 vaccine, SCB-2019: a phase 2 and 3 multicentre, double-blind, randomised, placebo-controlled trial
Jan/20/2022

Clinical trials

ID Title Status Phase Start date Completion date
NCT05012787 A Study of Safety and Immunogenicity of Adjuvanted SARS-CoV-2 (SCB-2019) Vaccine in Adults With Chronic Immune-Mediated Diseases Not yet recruiting Phase 3 Sep/13/2021 Dec/16/2022
  • Alternative id - CLO-SCB-2019-005
  • Interventions - Biological: CpG 1018/Alum-adjuvanted SCB-2019 vaccine|Biological: Havrix|Other: Placebo; 0.9% saline
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Brandwag, Bloemfontein, Brandwag, Bloemfontein, South Africa|Cape Town, Cape Town, South Africa|Kyiv, Kyiv, Ukraine|Kyiv, Kyiv, Ukraine
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
  • Enrollment - 300
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Percentage of Participants With Unsolicited Adverse Events (AEs)|Percentage of Participants With Medically Attended AEs (MAAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)|Percentage of Participants With Any Confirmed Relapse of Immune-mediated Disease (RA, IBD, or RRMS)|Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb)|Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb|Number of Participants With Seroconversion for SARS-CoV-2 nAb|Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody|Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody|Number of Participants With Seroconversion for SCB-2019 Binding Antibody|Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants With RA, IBD, and RRMS|Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants With RA, IBD, and RRMS|Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants With RA, IBD and RRMS|Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants With RA, IBD, and RRMS|Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants With RA, IBD, and RRMS|Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants With RA, IBD, and RRMS|Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants Who Receive Corticosteroids|Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants Who Receive Corticosteroids|Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants Who Receive Corticosteroids|Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants Who Receive Corticosteroids|Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants Who Receive Corticosteroids|Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants Who Receive Corticosteroids|Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants Who Receive Tumor Necrosis Factor (TNF)-alpha Inhibitors|Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants Who Receive TNF-alpha Inhibitors|Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants who Received TNF-alpha Inhibitors|Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants Who Receive TNF-alpha Inhibitors|Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants Who Receive TNF-alpha Inhibitors|Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants Who Receive TNF-alpha Inhibitors|Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants Who Receive Immunomodulators|Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants Who Receive Immunomodulators|Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants who Receive Immunomodulators|Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants Who Receive Immunomodulators|Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants Who Receive Immunomodulators|Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants Who Receive Immunomodulators|Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants Who Receive Other Treatment Regimens|Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants Who Receive Other Treatment Regimens|Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants Who Receive Other Treatment Regimens|Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants Who Receive Other Treatment Regimens|Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants Who Receive Other Treatment Regimens|Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants Who Receive Other Treatment Regimens|Number of Participants With Local and Systemic Solicited AEs
NCT04672395 A Controlled Phase 2/3 Study of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Vaccine (SCB-2019) for the Prevention of COVID-19 Recruiting Phase 2|Phase 3 Mar/24/2021 Jul/01/2022
  • Alternative id - CLO-SCB-2019-003
  • Interventions - Biological: CpG 1018/Alum-adjuvanted SCB-2019 vaccine|Biological: Placebo; 0.9% saline|Biological: SCB-2019 vaccine|Biological: SCB-2019 vaccine for Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Anima, Alken, Belgium|Hôspital Erasme, Bruxelles, Belgium|Private Practice RESPISOM Namur, Namur, Belgium|Instituto D'OR de Pesquisa e Ensino, Rio de Janeiro, Rio Do Janeiro, Brazil|Instituto Atena de Pesquisa Clinica, Natal, Rio Grande Do Norte, Brazil|CPCLIN - Centro de Pesquisas Clínicas de Natal, Natal, Rio Grande Do Norte, Brazil|Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil|Hospital da Universidade Federal de Santa Maria CEP/UFSM, Santa Maria, Rio Grande Do Sul, Brazil|Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede, Acacias, Acacías, Colombia|Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede Aguazul, Aguazul, Colombia|Clínica de la Costa Ltda, Barranquilla, Colombia|Fundación Hospital Universitario del Norte, Barranquilla, Colombia|Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede, Bogotá D.C., Bogotá, Colombia|Policlinico Social del Norte, Bogotá, Colombia|Centro de Estudios en Infectología Pediátrica S.A.S. - CEIP S.A.S., Cali, Colombia|IPS Médicos Internistas de Caldas SAS, Manizales, Colombia|Centro de Atención e investigación Médica S.A.S, CAIMED S.A.S - sede, Yopal, Yopal, Colombia|De La Salle Medical and Health Sciences Institute, Dasmariñas, Cavite, Philippines|Las Pinas Doctors Hospital, Las Piñas, Philippines|Tropical Disease Foundation, Makati, Philippines|Manila Doctors Hospital, Manila, Philippines|Asian Hospital and Medical Center, Muntinlupa, Philippines|University of the Philippines Manila - Philippine General Hospital, Pasay, Philippines|UERM Memorial Medical Center, Quezon City, Philippines|University of the East Ramon Magsaysay Memorial Medical Center, Quezon City, Philippines|FEU-NRMF Medical Center, Quezon City, Philippines|St. Luke's Medical Center, Taguig, Philippines|Wits Clinical Research, Johannesburg, Gauteng, South Africa|DJW Research, Krugersdorp, Gauteng, South Africa|Soweto Clinical Trials Centre, Soweto, Gauteng, South Africa|Dr JM Engelbrecht Trial Site, Somerset West, Western Cape, South Africa
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 30000
  • Age - 12 Years and older   (Child, Adult, Older Adult)
  • Outcome measures - Number of Participants with a First Occurrence of COVID-19 of Any Severity Starting 14 Days after Second Dose of SCB-2019|Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)|Number of Participants with Unsolicited AEs|Number of Participants with Serious Adverse Events (SAEs), or Medically Attended AEs (MAAEs), or AEs Leading to Early Termination, or Adverse Events of Special Interest (AESIs)|Non-inferiority of the neutralizing titers after third dose compared to the neutralizing titers after second dose|Number of Participants with a First Occurrence of Moderate-to-Severe COVID-19 Starting 14 Days after Second Dose of SCB-2019|Number of Participants with First Occurrence of Any Laboratory-Confirmed SARS-CoV-2 infection Starting 14 Days after Second Dose of SCB-2019 or Placebo|Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of SCB-2019 or Placebo|Number of Participants with First Occurrence of Any Laboratory-Confirmed Asymptomatic SARS-CoV-2 infection Starting 14 Days after Second Dose of SCB-2019 or Placebo|Burden of Disease Score of COVID-19 or SARS-CoV-2 Infection Cases Starting 14 Days after Second Dose of SCB-2019 or Placebo|Number of Participants with a First Occurrence of COVID-19 of Any Severity, Associated with Hospitalization, Starting 14 Days after Second Dose of SCB-2019 or Placebo|Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of SCB-2019 or Placebo, regardless of evidence of prior SARS-CoV-2 Infection|Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of SCB-2019 or Placebo, regardless of risk of severe COVID-19|Number of Participants with a First Occurrence of COVID-19 Starting 14 days after First Dose of SCB-2019 or Placebo|Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)|Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb|Number of Participants with Seroconversion for SARS-CoV-2 Specific nAb|Geometric Mean Titer (GMT) of SARS-CoV-2 antibodies competing for binding of S protein to the human ACE2 receptor|Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 antibodies competing for binding of S protein to the human ACE2 receptor|Number of Participants with Seroconversion for of SARS-CoV-2 antibodies competing for binding of S protein to the human ACE2 receptor|Geometric Mean Titer (GMT) of SCB-2019 binding antibody|Geometric Mean Fold Rise (GMFR) of SCB-2019 binding antibody|Number of Participants with Seroconversion for SCB-2019 binding antibody|Geometric Mean Titer (GMT) of Trimer-Tag binding antibody|Geometric Mean Fold Rise (GMFR) of Trimer-Tag binding antibody|Non-inferiority of the neutralising titers in adolescents versus young adults.
NCT04932824 Long-term Follow-up to the Phase 1 Study of Adjuvanted SARS-CoV-2 (SCB 2019) Vaccine for COVID-19. Completed Phase 1 Jan/19/2021 Dec/16/2021
  • Alternative id - CLO-SCB-2019-002
  • Interventions - Biological: SCB-2019
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Linear Clinical Research, Nedlands, Territory Western Australia, Australia
  • Study designs - Allocation: Non-Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 137
  • Age - 18 Years to 75 Years   (Adult, Older Adult)
  • Outcome measures - Incidence of AESIs and SAEs|Serum anti-SCB-2019 IgG antibody titers|Serum anti-SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based)
NCT04954131 Immunogenicity and Safety Study of Adjuvanted SARS-CoV-2 (SCB-2019) Vaccine in Adultsin China Active, not recruiting Phase 2 Aug/10/2021 Nov/15/2022
  • Alternative id - CLO-SCB-2019-010
  • Interventions - Biological: Candidate Vaccine, SCB-2019|Other: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Shanxi Center for Disease Control and prevention, Taiyuan, Shanxi, China|Sichuan Center for disease control, Chengdu, Sichuan, China
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 766
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - GMT ratio of GMT-CLO-SCB-2019-010 over GMT-CLO-SCB-2019-003
NCT04405908 SCB-2019 as COVID-19 Vaccine Completed Phase 1 Jun/19/2020 Dec/08/2021
  • Alternative id - CLO-SCB-2019-001
  • Interventions - Biological: SCB-2019|Biological: SCB-2019 with AS03 adjuvant|Biological: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant|Biological: SCB-2019 with Alum adjuvant
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Linear Clinical Research Ltd, Nedlands, Western Australia, Australia
  • Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 166
  • Age - 18 Years to 75 Years   (Adult, Older Adult)
  • Outcome measures - Incidence of solicited adverse events (AEs) after vaccination|Incidence of unsolicited AEs after vaccination|Mean change from Baseline in safety laboratory measures (include hematology, coagulation panel, and serum chemistry)|Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)|As assessed by serum anti-SCB-2019 IgG antibody titers|Immunogenicity( serum anti SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based) )|Immunogenicity(serum anti SARS-CoV-2 neutralizing antibody titers (cell based) )|Immunogenicity(serum anti SARS-CoV-2 whole virus antibody titers)|Antibody kinetics of each SCB 2019 vaccine formulation after first and second doses
NCT05228314 Safety and Immunogenicity Dose-finding Study of Adjuvanted SCB-2020S Vaccine in Adults Not yet recruiting Phase 1 Mar/01/2022 Sep/01/2023
  • Alternative id - CLO-SCB-2020S-002
  • Interventions - Biological: Candidate vaccine, SCB-2020S|Biological: Candidate vaccine, SCB-2019|Other: Squalene based adjuvant|Other: CpG/alum adjuvant
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 152
  • Age - 18 Years to 75 Years   (Adult, Older Adult)
  • Outcome measures - Number of participants with local and systemic adverse events (AEs) after vaccination with SCB-2020S vaccine.|Number of participants with unsolicited AEs after vacccination with SCB-2020S vaccine|Number of participants with MAAEs, SAEs, AESIs and AEs leading to discontinuation from study.|Number of participants with abnormal results in hematology parameters (hemoglobin, platelet count, red blood cell count, total and differential white blood cell count).|Number of participants with abnormal results in biochemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, creatinine, total protein).|Number of participants with abnormal results in coagulation parameters (activated partial thromboplastin, prothrombin time).|Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibody (nAb)|Proportion of participants achieving seroconversion for SARS-CoV-2 nAb|Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb|Proportion of participants with nAb above a certain threshold|GMT of SCB-2019 Binding Antibody|Proportion of participants achieving seroconversion for SCB-2019 binding antibody|GMFR of SCB-2019 binding antibody|SCB-2019 binding antibody above lower limit of quantification.
NCT05188677 Immunogenicity and Safety Study of a SCB-2019 Vaccine Booster Dose to Adults Who Previously Received Primary Series of Selected COVID-19 Vaccines Not yet recruiting Phase 3 Mar/01/2022 Feb/01/2023
  • Alternative id - CLO-SCB-2019-015
  • Interventions - Biological: Candidate vaccine, SCB-2019
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Clínica de la Costa Ltda, Barranquilla, Colombia|Centro de Estudios en Infectología Pediátrica S.A.S. - CEIP S.A.S., Cali, Colombia
  • Study designs - Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 1000
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Geometric Mean Titer (GMT) ratio of GMT booster over GMT primary series|SCR difference: Seroconversion Rate (SCR) booster minus SCR primary series;|Local and systemic solicited AEs reported within 7 days after study vaccination|Unsolicited AEs reported from Visit 1 (Day 1) through Safety Call Day 43|SAEs, AEs leading to early termination from the study, MAAEs, and AESIs|GMT ratio of GMT heterologous over GMT homologous;|SCR difference: SCR heterologous minus SCR homologous;
NCT05087368 Immunogenicity and Safety of Heterologous and Homologous Boosting With ChAdOx1-S and CoronaVac or a Formulation of SCB-2019 (COVID-19) Not yet recruiting Phase 2 Dec/01/2021 Apr/01/2022
  • Alternative id - TP-SCB-2019-001
  • Interventions - Biological: ChAdOx1-S COVID-19 Vaccine(Fiocruz/Oxford-AstraZeneca)|Biological: CoronaVac (Sinovac Biotech)|Biological: Adjuvanted Recombinant SARS-CoV-2 TrimericS-protein Subunit Vaccine (SCB-2019 - Clover)
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio De Grande Do Sul, Brazil|Hospital Gloria D'or, Rio De Janeiro, Rio De, Brazil|Centro de Estudos e Pesquisa em Moléstias Infecciosas (CEPCLIN), Natal, Rio Grande Do Norte, Brazil
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 520
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Immunogenicity - Stage 1|Immunogenicity - Stage 2|Reactogenicity
NCT05193279 Safety and Immunogenicity of SCB-2019 in Children <18 Years of Age Not yet recruiting Phase 2|Phase 3 Mar/01/2022 Jul/01/2024
  • Alternative id - CLO-SCB-2019-007
  • Interventions - Biological: Candidate vaccine, SCB-2019
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Clínica de la Costa Ltda, Barranquilla, Colombia|Centro de Estudios en Infectología Pediátrica S.A.S. - CEIP S.A.S., Cali, Colombia
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 3820
  • Age - up to 17 Years   (Child)
  • Outcome measures - Phase 2, select optimal dose level of SCB-2019 vaccine by age cohort (5-11 years, 2-4 years, and < 2 years), based on safety|Phase 2, select optimal dose level of SCB-2019 vaccine in phase 2 by age cohort (5-11 years, 2-4 years, and < 2 years), based on immunogenicity|Phase 3, non-inferiority (GMT) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 5 to < 12 years as compared to young adults (18 to < 25 years)|Phase 3, non-inferiority (GMT) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 2 to < 5 years as compared to young adults (18 to < 25 years)|Phase 3, non-inferiority (GMT) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants birth to < 2 years as compared to young adults (18 to < 25 years)|Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 5 to < 12 years as compared to young adults (18 to < 25 years)|Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 2 to < 5 years as compared to young adults (18 to < 25 years)|Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants birth to < 2 years as compared to young adults (18 to < 25 years)|In phase 2 and 3, GMT of SARS-CoV-2 nAb|In phase 2 and 3, proportion of participants achieving seroconversion for SARS-CoV-2 nAb|In phase 2 and 3, GMFR in SARS-CoV-2 nAb|In phase 2 and 3, proportion of participants with SARS-CoV-2 nAb above a certain threshold|In phase 2 and 3, GMT of SCB-2019 Binding Antibody|In phase 2 and 3, proportion of participants achieving seroconversion for SCB-2019 binding antibody|In phase 2 and 3, GMFR of SCB-2019 binding antibody|In phase 2 and 3, proportion of participants with SCB-2019 binding antibody above a certain threshold|In phase 3, reactogenicity of the vaccine as indicated by the occurrence of solicited local and systemic reactions|Phase 2 and 3, safety of the vaccine in terms of occurrence of unsolicited adverse events|Phase 2 and 3, safety of the vaccine in terms of occurrence of MAAEs, SAEs, adverse events leading to discontinuation from study, and AESIs.
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