Other substances

CVnCoV

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
6
 AI-suggested references
8
 Clinical trials

General information

CVnCoV is a COVID-19 candidate vaccine being developed by Curevac. It is an mRNA type of candidate vaccine. It is based on the RNA platform, which is also used for non-COVID-19 candidates, such as RABV, LASV, YFV; MERS, InfA, ZIKV, DengV, and NIPV. 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
Analysis of BNT162b2- and CVnCoV-elicited sera and of convalescent sera toward SARS-CoV-2 viruses.
Jan/30/2022
Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial
Dec/02/2021
A Third Dose of the COVID-19 Vaccine, CVnCoV, Increased the Neutralizing Activity against the SARS-CoV-2 Wild-Type and Delta Variant
Apr/01/2021
mRNA-based SARS-CoV-2 vaccine candidate CVnCoV induces high levels of virus-neutralising antibodies and mediates protection in rodents
Mar/01/2022
Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in ten countries in Europe and Latin America (HERALD): a randomised, observer-blinded, placebo-controlled, phase 2b/3 trial.
Nov/23/2021
CVnCoV and CV2CoV protect human ACE2 transgenic mice from ancestral B BavPat1 and emerging B.1.351 SARS-CoV-2
Jun/30/2021

Clinical trials

ID Title Status Phase Start date Completion date
NCT04652102 A Study to Determine the Safety and Efficacy of SARS-CoV-2 mRNA Vaccine CVnCoV in Adults for COVID-19 Active, not recruiting Phase 2|Phase 3 Dec/14/2020 Jun/04/2022
  • Alternative id - CV-NCOV-004|2020-003998-22
  • Interventions - Biological: CVnCoV|Biological: Placebo|Biological: Authorized/licensed vaccines for preventing COVID-19 (AV)
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Instituto de Investigaciones Clinicas Quilmes, Buenos Aires, Argentina|Hospital Interzonal General Agudos Prof. Dr. Ramon Carrillo, Buenos Aires, Argentina|Hospital Interzonal General de Agudos Vicente Lopez y Planes, Buenos Aires, Argentina|Hospital Zonal General de Agudos Descentralizado Evita Pueblo de Berazategui, Buenos Aires, Argentina|Fundación Cenit Para La Investigación En Neurociencias, Buenos Aires, Argentina|Instituto de Investigaciones Clínicas Mar del Plata, Mar Del Plata, Argentina|Sanatorio Parque, Rosario, Argentina|Corporación Médica Sanatorio, San Martín, Argentina|Instituto De Investigaciones Clinica Zarate, Zárate, Argentina|Cohezio - Bruxelles, Brussels, Belgium|Mensura, Brussel, Belgium|Universitair Ziekenhuis Gent, Gent, Belgium|Clínica de la Costa, Barranquilla, Colombia|CAIMED - Bogota Clinical Research Center, Bogotá, Colombia|Centro de Estudios en Infectología Pediátrica (CEIP), Cali, Colombia|Fundacion Dominicana de Perinatologia Pro Bebe, Santo Domingo, Dominican Republic|Instituto Dermatológico Dominicano y Cirugía de Piel Dr. Huberto Bogaert Díaz, Santo Domingo, Dominican Republic|Clínica Cruz Jiminian, Santo Domingo, Dominican Republic|Hospital General Regional Marcelino Vélez Santana, Santo Domingo, Dominican Republic|Uniklinik Köln, Köln, Germany|Ludwig-Maximilians-Universität München, München, Germany|Universitätsklinikum Tübingen - Institut für Tropenmedizin, Reisemedizin und Humanparasitologie, Tübingen, Germany|Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran, Ciudad de mexico, Mexico|CAIMED - México, Ciudad de mexico, Mexico|Panamerican Clinical research Mexico (Guadalajara), Guadalajara, Mexico|Panamerican Clinical Research Mexico S.A. DE C.V., Juriquilla, Mexico|Unidad de Medicina Especializada SMA, San Juan Del Río, Mexico|Centro Medico Zambrano Hellion TecSalud, San Pedro Garza Garcia, Mexico|Noordwest Ziekenhuisgroep, Alkmaar, Netherlands|Amsterdam Universitair Medische Centra - Academisch Medisch Centrum, Amsterdam, Netherlands|The Julius Center - Utrecht Science Park - Stratenum, Utrecht, Netherlands|Centro De Vacunacion Internacional - CEVAXIN Chorreras, Panama city, Panama|Centro De Vacunacion Internacional - CEVAXIN 24 Diciembre, Panama City, Panama|Centro de Vacunacion Internacional - CEVAXIN Avenida Mexico, Panama city, Panama|Instituto de Investigaciones Científicas y Servicios de Alta Tecnología, Panamá, Panama|Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Callao, Peru|Hospital de Chancay y Servicios básicos de Salud, Chancay, Peru|Clinica Medica San Martin, Ica, Peru|Instituto de Investigación Nutricional - Las Gardenias, Lima, Peru|Instituto de Investigación Nutricional - San Carlos, Lima, Peru|Instituto de Investigación Nutricional, Lima, Peru|Asociación Civil Impacta Salud y Educación, Lima, Peru|Centro de Investigación para ensayos Clínicos UPCH, Lima, Peru|OSI Eskerraldea-Enkarterri-Cruces/Hospital Universitario Cruces, Barakaldo, Spain|Hospital Universitario Donostia, Donostia-San Sebastián, Spain|Hospital Clínico San Carlos, Madrid, Spain
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
  • Enrollment - 39693
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity|Number of participants who experience one or more medically-attended adverse events (AEs)|Intensity grading of medically-attended adverse events (AEs) as per adapted Food and Drug Administration (FDA) classification|Number of participants who experience one or more treatment-related medically-attended adverse events (AEs)|Number of participants who experience one or more serious adverse events (SAEs)|Intensity grading of serious adverse events (SAEs) as per adapted FDA classification|Number of participants who experience one or more treatment-related serious adverse events (SAEs)|Number of participants who experience one or more adverse events of special interest (AESI)|Intensity grading of adverse events of special interest (AESI) as per adapted FDA classification|Number of participants who experience one or more treatment-related adverse events of special interest (AESI)|Number of participants who experience a fatal serious adverse event (SAE)|Number of participants who experience an adverse event (AE) leading to authorized/licensed vaccines withdrawal or trial discontinuation after first dose with an authorized/licensed vaccine for preventing COVID-19 (AV) administered|Phase 2b participants only: Number of participants who experience one or more solicited local adverse events (AEs)|Phase 2b participants only: Intensity grading of solicited local adverse events (AEs) as per adapted FDA classification|Phase 2b participants only: Duration of solicited local adverse events (AEs)|Phase 2b participants only: Number of participants who experience one or more solicited systemic adverse events (AE)|Phase 2b participants only: Intensity grading of solicited systemic adverse events (AEs) as per adapted FDA classification|Phase 2b participants only: Duration of solicited systemic adverse events (AEs)|Phase 2b participants only: Number of participants who experience one or more unsolicited adverse events (AEs)|Phase 2b participants only: Intensity grading of unsolicited adverse events (AEs) as per adapted FDA classification|Phase 2b participants only: Number of participants who experience one or more treatment-related unsolicited adverse events (AEs)|Number of participants who experience one or more adverse events (AEs) leading to vaccine withdrawal or trial discontinuation|Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} moderate to severe case of COVID-19|Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} severe case of COVID-19|Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity due to infection with "wild type" and "UK" SARS-CoV-2 strains|Number of participants aged ≥ 61 who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity|Number of participants who experience a virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} SARS-CoV-2 infection, with or without symptoms|Burden of disease (BoD) based on first episodes of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} cases of COVID-19|Number of participants who experience a virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity with symptom onset at any time after the first study vaccination|Number of participants with serum antibodies to SARS-CoV-2 spike (S) protein|Number of participants who experience seroconversion to SARS-CoV-2 spike (S) protein|Number of participants with serum vital neutralizing antibodies to SARS-CoV-2 virus|Number of participants who experience seroconversion to SARS-CoV-2 virus
NCT04515147 A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19 Active, not recruiting Phase 2 Sep/28/2020 Feb/18/2022
  • Alternative id - CV-NCOV-002
  • Interventions - Biological: CVnCoV 6 μg|Biological: CVnCoV 12 μg|Biological: Hepatitis A vaccine|Biological: Pneumococcal vaccine|Biological: CVnCoV 12μg
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Centro de vacunación internacional - CEVAXIN Panama Clinic, Panama city, Panama|Instituto de Investigación Nutricional, Lima, Peru
  • Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 674
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Number of Participants with Solicited Local Adverse Events|Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale|Duration of Solicited Local Adverse Events|Number of Participants with Solicited Systemic Adverse Events|Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale|Duration of Solicited Systemic Adverse Events|Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine|Number of Participants with Unsolicited Adverse Events|Intensity of Unsolicited Adverse Events per the FDA Toxicity Grading Scale|Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine|Number of Participants with One or More Serious Adverse Events (SAEs)|Number of Participants with One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine|Number of Participants with One or More Adverse Events of Special Interest (AESIs)|Number of Participants with One or More Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine|Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies|Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum|Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies|Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies|Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum|Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies|Number of Participants with Solicited Local Adverse Events Following the Booster Vaccine|Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale Following the Booster Vaccine|Duration of Solicited Local Adverse Events Following the Booster Vaccine|Number of Participants with Solicited Systemic Adverse Events Following the Booster Vaccine|Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale Following the Booster Vaccine|Duration of Solicited Systemic Adverse Events Following the Booster Vaccine|Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine Following the Booster Vaccine|Number of Participants with Unsolicited Adverse Events Following the Booster Vaccine|Intensity of Unsolicited Adverse Events per the FDA Toxicity Grading Scale Following the Booster Vaccine|Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine Following the Booster Vaccine|Number of Participants who Experience a First Episode of Virologically-Confirmed {Reverse Transcription Polymerase Chain Reaction (RT-PCR) Positive} Case of COVID-19 of any Severity in all age Groups|Number of Participants who Experience a First Episode of Virologically-Confirmed {Reverse Transcription Polymerase Chain Reaction (RT-PCR) positive} Case of COVID-19 of any Severity per age Group|Number of Participants who Experience a First Episode of Virologically-Confirmed {Reverse Transcription Polymerase Chain Reaction (RT-PCR) Positive} case of COVID-19 of any Severity in all age Groups|Number of Participants who Experience a First Episode of Virologically-Confirmed {Reverse Transcription Polymerase Chain Reaction (RT-PCR) Positive} Case of COVID-19 of any Severity per age Group
NCT04860258 A Study to Evaluate Safety, Reactogenicity and Immunogenicity of the SARS-CoV-2 mRNA Vaccine CVnCoV in Adults With Co-morbidities for COVID-19 Completed Phase 3 Apr/22/2021 Sep/21/2021
  • Alternative id - CV-NCOV-003|2020-004070-22
  • Interventions - Biological: CVnCoV Vaccine
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Centre Hospitalier Universitaire Saint-Pierre, Brussels, Belgium|Université Libre de Bruxelles (ULB) - Hopital Erasme, Brussels, Belgium|Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc, Brussels, Belgium|Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman, Liège, Belgium
  • Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 129
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Number of Participants Who Experience a Solicited Local Adverse Event (AE)|Intensity of Solicited Local Adverse Events (AEs) per US Food and Drug Administration (FDA) Toxicity Grading Scale|Duration of Solicited Local Adverse Events (AEs)|Number of Participants Who Experience a Solicited Systemic Adverse Event (AE)|Intensity of Solicited Systemic Adverse Events (AEs) per US Food and Drug Administration (FDA) Toxicity Grading Scale|Duration of Solicited Systemic Adverse Events (AEs)|Number of Participants Who Experience a Treatment-Related Solicited Systemic Adverse Event (AE)|Number of Participants Who Experience an Unsolicited Adverse Event (AE)|Intensity of Unsolicited Adverse Events (AEs) per the Investigator's Assessment|Number of Participants Who Experience a Treatment-Related Unsolicited Adverse Event (AE)|Number of Participants Who Experience a Serious Adverse Event (SAE)|Number of Participants Who Experience a Treatment-Related Serious Adverse Event (SAE)|Number of Participants Who Experience an Adverse Event of Special Interest (AESI)|Number of Participants Who Experience a Treatment-Related Adverse Event of Special Interest (AESI)|Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies|Individual SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD)-Specific Antibody Levels in Serum|Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies|Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies|Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum|Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies
NCT04838847 A Study to Evaluate the Immunogenicity and Safety of the SARS-CoV-2 mRNA Vaccine CVnCoV in Elderly Adults Compared to Younger Adults for COVID-19 Withdrawn Phase 3 Oct/01/2021 Sep/01/2022
  • Alternative id - CV-NCOV-012|2020-005064-54
  • Interventions - Biological: CVnCoV Vaccine
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 0
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Antibody Concentrations Against SARS-CoV-2 Spike Protein-specific Immunoglobulin G (IgG) in Serum|Antibody Concentrations Against SARS-CoV-2 Spike Protein-specific Immunoglobulins in Serum|Number of Participants With Neutralizing Antibody Titers Against SARS-CoV-2 Spike Protein in Serum|Number of Participants Who Experience a Solicited Local Adverse Event (AE)|Intensity of Solicited Local Adverse Events (AEs) per the US Food and Drug Administration (FDA) Toxicity Grading Scale|Duration of Solicited Local Adverse Events (AEs)|Number of Participants Who Experience a Solicited Systemic Adverse Event (AE)|Intensity of Solicited Systemic Adverse Events (AEs) per the US Food and Drug Administration (FDA) Toxicity Grading Scale|Duration of Solicited Systemic Adverse Events (AEs)|Number of Participants Who Experience a Treatment-related Solicited Systemic Adverse Event (AE)|Number of Participants Who Experience an Unsolicited Adverse Event (AE)|Intensity of Unsolicited Adverse Events (AEs) per the Investigator's Assessment|Number of Participants Who Experience a Treatment-related Unsolicited Adverse Event (AE)|Number of Participants Who Experience a Medically Attended Adverse Event (AE)|Number of Participants Who Experience a Treatment-related Medically Attended Adverse Event (AE)|Number of Participants Who Experience a Medically Attended Serious Adverse Event (SAE)|Number of Participants Who Experience a Medically Attended Treatment-related Serious Adverse Event (SAE)|Number of Participants Who Experience a Medically Attended Adverse Event of Special Interest (AESI)|Number of Participants Who Experience a Treatment-related Medically Attended Adverse Event of Special Interest (AESI)|Number of Participants With Virologically-confirmed SARS-CoV-2 Infection
NCT04674189 A Study to Evaluate the Safety and Immunogenicity of Vaccine CVnCoV in Healthy Adults in Germany for COVID-19 Active, not recruiting Phase 3 Dec/23/2020 Jul/12/2022
  • Alternative id - CV-NCOV-005
  • Interventions - Biological: CVnCoV Vaccine|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Universitätsmedizin der Johannes Gutenberg-Universität Mainz Langenbeckstr. 1, Mainz, Germany
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
  • Enrollment - 2351
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Number of Participants with Medically-attended Adverse Events|Intensity of Medically-attended Adverse Events per Investigator's Assessment|Number of Participants with Medically-attended Adverse Events Considered Related to Trial Vaccine|Number of Participants with One or More Serious Adverse Events (SAEs)|Intensity of Serious Adverse Events (SAEs) per Investigator's Assessment|Number of Participants with One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine|Number of Participants with One or More Adverse Events of Special Interest (AESIs)|Intensity of Adverse Events of Special Interest (AESIs) per Investigator's Assessment|Number of Participants with One or More Serious Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine|Number of Participants with Death due to a Serious Adverse Event (SAE)|Number of Participants with Adverse Events (AEs) Leading to Vaccine Withdrawal or Study Discontinuation|Number of Participants with Solicited Local Adverse Events|Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale|Duration of Solicited Local Adverse Events|Number of Participants with Solicited Systemic Adverse Events|Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale|Duration of Solicited Systemic Adverse Events|Number of Participants with Unsolicited Adverse Events|Intensity of Unsolicited Adverse Events per the Investigator's Assessment|Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine|Individual SARS-CoV-2 Spike (S) Protein-Specific Antibody Levels in Serum|Number of Participants Seroconverting for SARS-CoV-2 Spike (S) Protein Antibodies|Number of Participants that Contract COVID-19 of Any Severity|Number of Participants that Contract Mild, Moderate, Severe and Moderate to Severe COVID-19|Burden of Disease (BoD) Score Based on First Episodes of Virologically-confirmed Cases of COVID-19|Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum|Number of Participants Seroconverting to SARS-CoV-2|Individual Serum Antibodies to Spike (S) Protein of SARS-CoV-2
NCT04834869 COVID-19 Vaccines Safety Tracking (CoVaST) Recruiting Apr/01/2021 Jan/31/2022
  • Alternative id - CoVaST
  • Interventions - Biological: BNT162b2|Biological: mRNA-1273|Biological: AZD1222|Biological: CoronaVac|Biological: Sinopharm|Biological: Gam-COVID-Vac|Biological: JNJ-78436735|Biological: CVnCoV|Biological: NVX-CoV2373|Biological: BBV152
  • Study type - Observational
  • Study results - No Results Available
  • Locations - American College of Physicians, Philadelphia, Pennsylvania, United States|McMaster University, Hamilton, Ontario, Canada|University of Split, Split, Croatia|Masaryk University, Brno, Czechia|University of Tartu, Tartu, Estonia|Jimma University, Jimma, Ethiopia|Justus-Liebig University Giessen, Giessen, Germany|University of Ghana, Accra, Ghana|Sinaloa's Pediatric Hospital, Culiacán, Mexico|Medical University of Silesia, Katowice, Poland|Nursing School of Coimbra, Coimbra, Portugal|Irkutsk Scientific Center of Siberian Branch of Russian Academy of Sciences, Irkutsk, Russian Federation|University of Belgrade, Belgrade, Serbia|University of Ljubljana, Ljubljana, Slovenia
  • Study designs - Observational Model: Other|Time Perspective: Prospective
  • Enrollment - 30000
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Local Side Effects|Systemic Side Effects|Unrecognized Side Effects
NCT04449276 A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults Completed Phase 1 Jun/18/2020 Dec/21/2021
  • Alternative id - CV-NCOV-001|2020-001286-36
  • Interventions - Biological: CVnCoV Vaccine|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Universitair Ziekenhuis Ghent, Ghent, Belgium|Ludwig-Maximilians-Universität München, München, Bavaria, Germany|Medical University Hannover (MHH), Hannover, Germany|University Hospital Tübingen Institut für Tropenmedizin, Tübingen, Germany
  • Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 280
  • Age - 18 Years to 60 Years   (Adult)
  • Outcome measures - Number of Participants With Grade 3 Adverse Reactions or any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination|Number of Participants With Grade 3 Adverse Reactions or any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination|Number of Participants with Solicited Local Adverse Events|Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale|Duration of Solicited Local Adverse Events|Number of Participants with Solicited Systemic Adverse Events|Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale|Duration of Solicited Systemic Adverse Events|Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine|Number of Participants with Unsolicited Adverse Events|Intensity of Unsolicited Adverse Events Assessed by the Investigator|Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine|Number of Participants with One or More Serious Adverse events (SAEs)|Number of Participants with One or More Serious Adverse events (SAEs) Considered Related to Trial Vaccine|Number of Participants with One or More Adverse Events of Special Interest (AESIs)|Number of Participants with One or More Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine|Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies|Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum|Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies|Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies|Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum|Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies
NCT04848467 COVID-19: A Trial Studying the SARS-CoV-2 mRNA Vaccine CVnCoV to Learn About the Immune Response, the Safety, and the Degree of Typical Vaccination Reactions When CVnCoV is Given at the Same Time as a Flu Vaccine Compared to When the Vaccines Are Separately Given in Adults 60 Years of Age and Older Withdrawn Phase 3 Oct/01/2021 Nov/15/2022
  • Alternative id - 21819
  • Interventions - Biological: SARS-CoV-2 mRNA Vaccine (CVnCoV)|Biological: Quadrivalent influenza vaccine (QIV)|Other: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 0
  • Age - 60 Years and older   (Adult, Older Adult)
  • Outcome measures - Antibody titers for SARS-CoV-2 receptor binding domain (RBD)|Hemagglutination inhibition (HI) titers for each of the 4 strains|Number of participants seroconverting for SARS-CoV- 2 spike protein antibodies|SARS-CoV-2 spike protein-specific antibody levels in serum|Number of participants seroconverting for SARS-CoV- 2 neutralizing antibodies|SARS-CoV-2 neutralizing antibody levels in serum|Number of participants with seroprotection for serum antibodies against the 4 influenza vaccine strains|Number of participants seroconverting for serum antibodies against the 4 influenza vaccine strains|Serum antibody titers against the 4 influenza vaccine strains|Number of participants with solicited local adverse events (AEs) of CVnCoV vaccine|Number of participants with solicited systemic AEs|Number of participants with unsolicited AEs|Number of participants with serious adverse event (SAEs)|Number of participants with adverse event of special interest (AESIs)
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