Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003998-22 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of the randomized observer-blinded phase 2b/3 part of this trial is to demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any severity in SARS-CoV-2 naïve participants.
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized Observer-blinded Phase 2b: CVnCoV vaccine | Experimental | Participants will be vaccinated with CVnCoV 12 µg vaccine on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm. |
|
| Randomized Observer-blinded Phase 2b: Placebo | Placebo Comparator | Participants will be administered the matching placebo on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm. |
|
| Randomized Observer-blinded Phase 3: CVnCoV vaccine | Experimental | Participants will be vaccinated with CVnCoV 12 µg vaccine on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm. |
|
| Randomized Observer-blinded Phase 3: Placebo | Placebo Comparator | Participants will be administered the matching placebo on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm. |
|
| Open-label Phase | Experimental | After unblinding, the trial will shift from a randomized observer-blinded to an open-label design, and the following cohorts will be defined: Cohort A: participants who received at least 1 dose of CVnCoV in the randomized observer-blinded phases and choose to receive an authorized/licensed vaccine for preventing COVID-19 (AV) as standard of care through their national vaccination program. Cohort B: participants who received at least 1 dose of CVnCoV in the randomized observer-blinded phases and choose to remain in the trial without receiving any AV. Participants on the placebo arm will be withdrawn. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVnCoV | Biological | Intramuscular (IM) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced a First Episode of Virologically-confirmed {Reverse Transcription Polymerase Chain Reaction (RT-PCR) Positive} Case of COVID-19 of Any Severity | A case of COVID-19 meeting the definition for primary efficacy analysis was defined as follows:
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | Day 44 to Day 393 |
| Number of Participants Who Experienced One or More Medically-attended Adverse Events (AE) | Medically-attended AEs were defined as AEs with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Clinic visits for COVID-19 testing resulting in negative test results were not considered as medically attended visits, if there is no confirmed diagnosis and no prescribed concomitant medication. The Investigator assessed the relationship between trial vaccine and occurrence of each AE. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | Day 1 to Day 211 |
| Number of Participants Who Experienced One or More Serious AE (SAE) | An SAE was defined as any untoward medical occurrence that, at any dose:
The Investigator assessed the relationship between trial vaccine and occurrence of each SAE. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Moderate to Severe Case of COVID-19 | Moderate cases defined by any 1 of the following:
Severe cases defined by any 1 of the following:
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. |
Not provided
Inclusion Criteria:
Male or female participants 18 years of age or older.
Be willing and able to provide written informed consent prior to initiation of any trial procedures.
Expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit.
Females of non-childbearing potential defined as follows: surgically sterile (history of bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy) or postmenopausal {defined as amenorrhea for ≥12 consecutive months prior to screening (Day 1) without an alternative medical cause}. A follicle-stimulating hormone (FSH) level may be measured at the discretion of the Investigator to confirm postmenopausal status.
Females of childbearing potential: negative pregnancy test (human chorionic gonadotropin [hCG]) within 24 hours prior to each trial vaccination on Day 1 and Day 29.
Females of childbearing potential must use highly effective methods of birth control from 2 weeks before the first administration of the trial vaccine until 3 months following the last administration. The following methods of birth control are considered highly effective when used consistently and correctly:
Exclusion Criteria:
Roll-over Criteria for the Open-label Phase:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Investigaciones Clinicas Quilmes | Buenos Aires | 1878 | Argentina | |||
| Hospital Interzonal General Agudos Prof. Dr. Ramon Carrillo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34826381 | Derived | Kremsner PG, Ahuad Guerrero RA, Arana-Arri E, Aroca Martinez GJ, Bonten M, Chandler R, Corral G, De Block EJL, Ecker L, Gabor JJ, Garcia Lopez CA, Gonzales L, Granados Gonzalez MA, Gorini N, Grobusch MP, Hrabar AD, Junker H, Kimura A, Lanata CF, Lehmann C, Leroux-Roels I, Mann P, Martinez-Resendez MF, Ochoa TJ, Poy CA, Reyes Fentanes MJ, Rivera Mejia LM, Ruiz Herrera VV, Saez-Llorens X, Schonborn-Kellenberger O, Schunk M, Sierra Garcia A, Vergara I, Verstraeten T, Vico M, Oostvogels L; HERALD Study Group. 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. Lancet Infect Dis. 2022 Mar;22(3):329-340. doi: 10.1016/S1473-3099(21)00677-0. Epub 2021 Nov 23. |
Not provided
Not provided
Of the 39680 participants who were randomized, 39540 participants received at least one dose vaccine.
This trial was performed in Argentina, Belgium, Colombia, the Dominican Republic, Germany, Mexico, the Netherlands, Panama, Peru and Spain between 11 December 2020 and 10 June 2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CVnCoV 12 μg Vaccine | Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 25, 2021 | Dec 8, 2022 |
Not provided
Not provided
Not provided
Not provided
The randomized observer-blinded phases of this study are participant and investigator blinded. This is followed by an open-label phase.
|
|
| Placebo | Biological | Intramuscular (IM) injection. |
|
| Authorized/licensed vaccines for preventing COVID-19 (AV) as standard of care through their national vaccination program | Biological | Intramuscular (IM) injection will be received as standard of care (SoC) outside the study. |
|
| Day 1 to Day 393 |
| Intensity of SAEs as Per Investigator Assessment | An SAE was defined as any untoward medical occurrence that, at any dose:
The Investigator made an assessment of intensity of each SAE reported during the trial. Each SAE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | Day 1 to Day 393 |
| Number of Participants Who Experienced One or More Adverse Event of Special Interest (AESI) | AESIs included:
The Investigator assessed the relationship between trial vaccine and occurrence of each AESI. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | Day 1 to Day 393 |
| Number of Participants Who Experienced a Fatal SAE | A fatal SAE was defined as an SAE that resulted in death. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | Day 1 to Day 393 |
| Phase 2b Participants Only: Number of Participants Who Experienced One or More Solicited AE | Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36) |
| Phase 2b Participants Only: Intensity of Solicited AEs as Per Investigator Assessment | Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary. The Investigator made an assessment of intensity of each solicited AE reported during the trial. Each solicited AE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36) |
| Phase 2b Participants Only: Duration of Solicited AEs | Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary. Duration is calculated as consecutive days with a respective solicited AE regardless of the grade of the AE. AEs ongoing after Day 8 are included. In each case only the longest consecutive duration is displayed. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36) |
| Phase 2b Participants Only: Number of Participants Who Experienced One or More Unsolicited AE | eDiaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57) |
| Phase 2b Participants Only: Intensity of Unsolicited AEs as Per Investigator Assessment | eDiaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator made an assessment of intensity of each unsolicited AE reported during the trial. Each unsolicited AE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57) |
| Number of Participants Who Experienced One or More AEs Leading to Vaccine Withdrawal or Trial Discontinuation | Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | Day 1 to Day 393 |
| Day 44 to Day 393 |
| Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Severe Case of COVID-19 | Severe COVID-19 cases were defined by any one of the following:
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | Day 44 to Day 393 |
| Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Case of COVID-19 of Any Severity Due to Infection With "Wild Type" and "Alpha" SARS-CoV-2 Strains in SARS-CoV-2 Naïve Participants | The characterization of SARS-CoV-2 variants were implemented by viral whole genome sequencing of nasopharyngeal swab samples of participants followed by comparison with previously sequenced and typified genomes. The following phylogenetic clustering was applied:
A case of COVID-19 was defined as follows:
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | Day 44 to Day 393 |
| Number of Participants Aged ≥ 61 Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Case of COVID-19 of Any Severity | A case of COVID-19 was defined as follows:
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | Day 44 to Day 393 |
| Burden of Disease (BoD) Score #1 Based on First Episodes of Virologically-confirmed (RT-PCR Positive) Cases of COVID-19 | Score #1 was defined as no disease (not infected or asymptomatic infection) = 0; mild or moderate disease = 1; severe disease = 2. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | Day 44 to Day 393 |
| BoD Score #2 Based on First Episodes of Virologically-confirmed (RT-PCR Positive) Cases of COVID-19 | Score #2 was defined as no disease (not infected or asymptomatic infection) = 0; disease without hospitalization = 1; disease with hospitalization = 2; death = 3. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | Day 44 to Day 393 |
| SARS-CoV-2 Receptor Binding Domain (RBD) of Spike (S) Protein Antibody Levels on Days 1, 29, 43, 120 and 211 | Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by enzyme- linked immunosorbent assay (ELISA) and expressed as geometric mean of titers (GMT) with 95% confidence interval (CI), by group. Individual values below the lower limit of quantification (LLOQ) were set to half of the LLOQ. Only participants seronegative at baseline with evaluable samples at each visit are included. Participants who tested positive for SARS-CoV-2 via PCR or N-protein antibodies had their data included up to the point of positive test result or symptom onset. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. | Days 1 (baseline), 29, 43, 120 and 211 |
| Percentage of Participants Seroconverting to SARS-CoV-2 RBD of S Protein Antibodies on Days 29, 43, 120 and 211 | Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by ELISA. Percentage with 95% CI of participants for whom a seroconversion was observed is presented by group. In participants who tested seronegative to the N protein for SARS-CoV-2 at baseline, seroconversion was defined as a fold increase above 1 in antibody titer against SARS-CoV-2 RBD of S protein. Only participants seronegative at baseline with evaluable samples at each visit are included. Participants who tested positive for SARS-CoV-2 via PCR or N-protein antibodies had their data included up to the point of positive test result or symptom onset. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. | Baseline and Days 29, 43, 120 and 211 |
| SARS-CoV-2 Viral Neutralizing Antibody Levels on Days 1, 29, 43, 120 and 211 | Titers of viral neutralizing antibodies were determined by an activity assay and expressed as GMT with 95% CI, by group. Individual values below the LLOQ were set to half of the LLOQ. Only participants seronegative at baseline with evaluable samples at each visit are included. Participants who have tested positive for SARS-CoV-2 via PCR or N-protein antibodies have their data included up to the point of positive test result or symptom onset. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. | Days 1 (baseline), 29, 43, 120 and 211 |
| Percentage of Participants Seroconverting to SARS-CoV-2 Viral Neutralizing Antibodies on Days 29, 43, 120 and 211 | Titers of viral neutralizing antibodies were determined by an activity assay. Percentage with 95% CI of participants for whom a seroconversion was observed is presented by group. In participants who tested seronegative to the N protein for SARS-CoV-2 at baseline, seroconversion was defined as a fold increase above 1 in antibody titer against SARS-CoV-2 neutralizing antibody titer. Only participants seronegative at baseline with evaluable samples at each visit are included. Participants who have tested positive for SARS-CoV-2 via PCR or N-protein antibodies have their data included up to the point of positive test result or symptom onset. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. | Baseline and Days 29, 43, 120 and 211 |
| Buenos Aires |
| B1702FWM |
| Argentina |
| Hospital Interzonal General de Agudos Vicente Lopez y Planes | Buenos Aires | B1748 | Argentina |
| Hospital Zonal General de Agudos Descentralizado Evita Pueblo de Berazategui | Buenos Aires | B1884LAD | Argentina |
| Fundación Cenit Para La Investigación En Neurociencias | Buenos Aires | C1125 ABD | Argentina |
| Instituto de Investigaciones Clínicas Mar del Plata | Mar del Plata | B7600FZN | Argentina |
| Sanatorio Parque | Rosario | S2000 | Argentina |
| Corporación Médica Sanatorio | San Martin | B1650CSQ | Argentina |
| Instituto De Investigaciones Clinica Zarate | Zárate | B2800DGH | Argentina |
| Cohezio - Bruxelles | Brussels | 1000 | Belgium |
| Mensura | Brussels | 1030 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Clínica de la Costa | Barranquilla | 80020 | Colombia |
| CAIMED - Bogota Clinical Research Center | Bogotá | 111621 | Colombia |
| Centro de Estudios en Infectología Pediátrica (CEIP) | Cali | 760042 | Colombia |
| Fundacion Dominicana de Perinatologia Pro Bebe | Santo Domingo | 10204 | Dominican Republic |
| Instituto Dermatológico Dominicano y Cirugía de Piel Dr. Huberto Bogaert Díaz | Santo Domingo | 10305 | Dominican Republic |
| Clínica Cruz Jiminian | Santo Domingo | 10501 | Dominican Republic |
| Hospital General Regional Marcelino Vélez Santana | Santo Domingo | 11001 | Dominican Republic |
| Uniklinik Köln | Cologne | 50937 | Germany |
| Ludwig-Maximilians-Universität München | München | 80802 | Germany |
| Universitätsklinikum Tübingen - Institut für Tropenmedizin, Reisemedizin und Humanparasitologie | Tübingen | 72074 | Germany |
| Panamerican Clinical research Mexico (Guadalajara) | Guadalajara | 44690 | Mexico |
| Panamerican Clinical Research Mexico S.A. DE C.V. | Juriquilla | 76226 | Mexico |
| Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran | Mexico City | 14080 | Mexico |
| CAIMED - México | Mexico City | 6760 | Mexico |
| Unidad de Medicina Especializada SMA | San Juan del Río | 76800 | Mexico |
| Centro Medico Zambrano Hellion TecSalud | San Pedro Garza García | 66278 | Mexico |
| Noordwest Ziekenhuisgroep | Alkmaar | 1815JD | Netherlands |
| Amsterdam Universitair Medische Centra - Academisch Medisch Centrum | Amsterdam | 1105 AZ | Netherlands |
| The Julius Center - Utrecht Science Park - Stratenum | Utrecht | 3584 CX | Netherlands |
| Centro De Vacunacion Internacional - CEVAXIN Chorreras | Panama City | 07064 | Panama |
| Instituto de Investigaciones Científicas y Servicios de Alta Tecnología | Panama City | 07097 | Panama |
| Centro De Vacunacion Internacional - CEVAXIN 24 Diciembre | Panama City | 07113 | Panama |
| Centro de Vacunacion Internacional - CEVAXIN Avenida Mexico | Panama City | 10662 | Panama |
| Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales | Callao | 07006 | Peru |
| Hospital de Chancay y Servicios básicos de Salud | Chancay | 15131 | Peru |
| Clinica Medica San Martin | Ica | 11000 | Peru |
| Instituto de Investigación Nutricional - Las Gardenias | Lima | 15024 | Peru |
| Instituto de Investigación Nutricional - San Carlos | Lima | 15024 | Peru |
| Instituto de Investigación Nutricional | Lima | 15024 | Peru |
| Asociación Civil Impacta Salud y Educación | Lima | 15063 | Peru |
| Centro de Investigación para ensayos Clínicos UPCH | Lima | 15102 | Peru |
| OSI Eskerraldea-Enkarterri-Cruces/Hospital Universitario Cruces | Barakaldo | 48903 | Spain |
| Hospital Universitario Donostia | Donostia / San Sebastian | 20014 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29. |
| Phase 2b Participants |
|
| Phase 3 Participants |
|
| Rolled Over to Open-Label Phase |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: Included all participants randomized into Phase 2b or 3 who received at least one dose of CVnCoV or placebo.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CVnCoV 12 μg Vaccine | Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29. |
| BG001 | Placebo | Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced a First Episode of Virologically-confirmed {Reverse Transcription Polymerase Chain Reaction (RT-PCR) Positive} Case of COVID-19 of Any Severity | A case of COVID-19 meeting the definition for primary efficacy analysis was defined as follows:
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | Efficacy Analysis Set (EAS): All participants randomized in Phase 2b or Phase 3 who received both doses of trial vaccine, had not developed a virologically-confirmed case of COVID-19 before trial entry or before 15 days after the second vaccination & were SARS-CoV-2 naïve at baseline & Day 43. Participants must have not developed an asymptomatic case of SARS-CoV-2, not stopped the trial, not received an AV for preventing COVID-19 or been unblinded prior to 15 days after the second vaccination. | Posted | Count of Participants | Participants | No | Day 44 to Day 393 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced One or More Medically-attended Adverse Events (AE) | Medically-attended AEs were defined as AEs with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Clinic visits for COVID-19 testing resulting in negative test results were not considered as medically attended visits, if there is no confirmed diagnosis and no prescribed concomitant medication. The Investigator assessed the relationship between trial vaccine and occurrence of each AE. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | Safety Analysis Set (SAS): Included all participants randomized in Phase 2b or 3 who received at least one dose of CVnCoV or placebo. | Posted | Count of Participants | Participants | Day 1 to Day 211 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced One or More Serious AE (SAE) | An SAE was defined as any untoward medical occurrence that, at any dose:
The Investigator assessed the relationship between trial vaccine and occurrence of each SAE. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | SAS: Included all participants randomized in Phase 2b or 3 who received at least one dose of CVnCoV or placebo. | Posted | Count of Participants | Participants | Day 1 to Day 393 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Intensity of SAEs as Per Investigator Assessment | An SAE was defined as any untoward medical occurrence that, at any dose:
The Investigator made an assessment of intensity of each SAE reported during the trial. Each SAE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | SAS: Included all participants randomized in Phase 2b or 3 who received at least one dose of CVnCoV or placebo. Only participants who experienced SAEs were included. | Posted | Count of Participants | Participants | Day 1 to Day 393 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced One or More Adverse Event of Special Interest (AESI) | AESIs included:
The Investigator assessed the relationship between trial vaccine and occurrence of each AESI. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | SAS: Included all participants randomized in Phase 2b or 3 who received at least one dose of CVnCoV or placebo. | Posted | Count of Participants | Participants | Day 1 to Day 393 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced a Fatal SAE | A fatal SAE was defined as an SAE that resulted in death. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | SAS: Included all participants randomized in Phase 2b or 3 who received at least one dose of CVnCoV or placebo. | Posted | Count of Participants | Participants | Day 1 to Day 393 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Phase 2b Participants Only: Number of Participants Who Experienced One or More Solicited AE | Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | The SASsol: Included all phase 2b participants of the SAS with at least one diary collection indicating the occurrence or lack of occurrence of solicited AEs. | Posted | Count of Participants | Participants | Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Phase 2b Participants Only: Intensity of Solicited AEs as Per Investigator Assessment | Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary. The Investigator made an assessment of intensity of each solicited AE reported during the trial. Each solicited AE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | The SASsol: Included all phase 2b participants of the SAS with at least one diary collection indicating the occurrence or lack of occurrence of solicited AEs. Only participants who experienced solicited AEs were included. | Posted | Count of Participants | Participants | No | Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Phase 2b Participants Only: Duration of Solicited AEs | Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary. Duration is calculated as consecutive days with a respective solicited AE regardless of the grade of the AE. AEs ongoing after Day 8 are included. In each case only the longest consecutive duration is displayed. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | The SASsol: Included all phase 2b participants of the SAS with at least one diary collection indicating the occurrence or lack of occurrence of solicited AEs. Only participants who experienced solicited AEs were included. | Posted | Mean | Standard Deviation | days | Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Phase 2b Participants Only: Number of Participants Who Experienced One or More Unsolicited AE | eDiaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | SAS 2: Included all Phase 2b participants of the SAS. | Posted | Count of Participants | Participants | Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Phase 2b Participants Only: Intensity of Unsolicited AEs as Per Investigator Assessment | eDiaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator made an assessment of intensity of each unsolicited AE reported during the trial. Each unsolicited AE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | SAS 2: Included all Phase 2b participants of the SAS. | Posted | Count of Participants | Participants | Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced One or More AEs Leading to Vaccine Withdrawal or Trial Discontinuation | Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | SAS: Included all participants randomized in Phase 2b or 3 who received at least one dose of CVnCoV or placebo. | Posted | Count of Participants | Participants | Day 1 to Day 393 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Moderate to Severe Case of COVID-19 | Moderate cases defined by any 1 of the following:
Severe cases defined by any 1 of the following:
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | EAS: All participants randomized in Phase 2b or Phase 3 who received both doses of trial vaccine, had not developed a virologically-confirmed case of COVID-19 before trial entry or before 15 days after the second vaccination, & were SARS-CoV-2 naïve at baseline and Day 43. Participants must have not developed an asymptomatic case of SARS-CoV-2, not stopped the trial, not received an AV for preventing COVID-19 or not been unblinded prior to 15 days after the second vaccination. | Posted | Count of Participants | Participants | Day 44 to Day 393 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Severe Case of COVID-19 | Severe COVID-19 cases were defined by any one of the following:
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | EAS: All participants randomized in Phase 2b or Phase 3 who received both doses of trial vaccine, had not developed a virologically-confirmed case of COVID-19 before trial entry or before 15 days after the second vaccination, & were SARS-CoV-2 naïve at baseline and Day 43. Participants must have not developed an asymptomatic case of SARS-CoV-2, not stopped the trial, not received an AV for preventing COVID-19 or not been unblinded prior to 15 days after the second vaccination. | Posted | Count of Participants | Participants | Day 44 to Day 393 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Case of COVID-19 of Any Severity Due to Infection With "Wild Type" and "Alpha" SARS-CoV-2 Strains in SARS-CoV-2 Naïve Participants | The characterization of SARS-CoV-2 variants were implemented by viral whole genome sequencing of nasopharyngeal swab samples of participants followed by comparison with previously sequenced and typified genomes. The following phylogenetic clustering was applied:
A case of COVID-19 was defined as follows:
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | EAS: All participants randomized in Phase 2b or Phase 3 who received both doses of trial vaccine, had not developed a virologically-confirmed case of COVID-19 before trial entry or before 15 days after the second vaccination, & were SARS-CoV-2 naïve at baseline and Day 43. Participants must have not developed an asymptomatic case of SARS-CoV-2, not stopped the trial, not received an AV for preventing COVID-19 or not been unblinded prior to 15 days after the second vaccination. | Posted | Count of Participants | Participants | Day 44 to Day 393 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Aged ≥ 61 Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Case of COVID-19 of Any Severity | A case of COVID-19 was defined as follows:
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | The EAS including only participants who were aged ≥ 61. | Posted | Count of Participants | Participants | Day 44 to Day 393 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Burden of Disease (BoD) Score #1 Based on First Episodes of Virologically-confirmed (RT-PCR Positive) Cases of COVID-19 | Score #1 was defined as no disease (not infected or asymptomatic infection) = 0; mild or moderate disease = 1; severe disease = 2. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | EAS: All participants randomized in Phase 2b or Phase 3 who received both doses of trial vaccine, had not developed a virologically-confirmed case of COVID-19 before trial entry or before 15 days after the second vaccination, & were SARS-CoV-2 naïve at baseline and Day 43. Participants must have not developed an asymptomatic case of SARS-CoV-2, not stopped the trial, not received an AV for preventing COVID-19 or not been unblinded prior to 15 days after the second vaccination. | Posted | Count of Participants | Participants | Day 44 to Day 393 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | BoD Score #2 Based on First Episodes of Virologically-confirmed (RT-PCR Positive) Cases of COVID-19 | Score #2 was defined as no disease (not infected or asymptomatic infection) = 0; disease without hospitalization = 1; disease with hospitalization = 2; death = 3. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | EAS: All participants randomized in Phase 2b or Phase 3 who received both doses of trial vaccine, had not developed a virologically-confirmed case of COVID-19 before trial entry or before 15 days after the second vaccination, & were SARS-CoV-2 naïve at baseline and Day 43. Participants must have not developed an asymptomatic case of SARS-CoV-2, not stopped the trial, not received an AV for preventing COVID-19 or not been unblinded prior to 15 days after the second vaccination. | Posted | Count of Participants | Participants | Day 44 to Day 393 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | SARS-CoV-2 Receptor Binding Domain (RBD) of Spike (S) Protein Antibody Levels on Days 1, 29, 43, 120 and 211 | Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by enzyme- linked immunosorbent assay (ELISA) and expressed as geometric mean of titers (GMT) with 95% confidence interval (CI), by group. Individual values below the lower limit of quantification (LLOQ) were set to half of the LLOQ. Only participants seronegative at baseline with evaluable samples at each visit are included. Participants who tested positive for SARS-CoV-2 via PCR or N-protein antibodies had their data included up to the point of positive test result or symptom onset. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. | Per Protocol Immunogenicity (PPI) Set: Included all Phase 2b participants from the Immunogenicity Subset who received both doses as randomized and within the specified windows, had no important protocol deviations that impacted immunogenicity outcomes, did not receive medical treatments that interfered with the proposed immunogenicity measurements and had at least one blood sample collected at baseline and starting at 14 days post-second vaccination available for analysis. | Posted | Geometric Mean | 95% Confidence Interval | titers | Days 1 (baseline), 29, 43, 120 and 211 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Seroconverting to SARS-CoV-2 RBD of S Protein Antibodies on Days 29, 43, 120 and 211 | Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by ELISA. Percentage with 95% CI of participants for whom a seroconversion was observed is presented by group. In participants who tested seronegative to the N protein for SARS-CoV-2 at baseline, seroconversion was defined as a fold increase above 1 in antibody titer against SARS-CoV-2 RBD of S protein. Only participants seronegative at baseline with evaluable samples at each visit are included. Participants who tested positive for SARS-CoV-2 via PCR or N-protein antibodies had their data included up to the point of positive test result or symptom onset. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. | PPI Set: Included all Phase 2b participants seronegative at baseline from the Immunogenicity Subset who received both doses as randomized & within the specified windows, had no important protocol deviations that impacted immunogenicity outcomes, did not receive medical treatments that interfered with the proposed immunogenicity measurements and had at least one blood sample collected at baseline and starting at 14 days post-second vaccination available for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Days 29, 43, 120 and 211 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | SARS-CoV-2 Viral Neutralizing Antibody Levels on Days 1, 29, 43, 120 and 211 | Titers of viral neutralizing antibodies were determined by an activity assay and expressed as GMT with 95% CI, by group. Individual values below the LLOQ were set to half of the LLOQ. Only participants seronegative at baseline with evaluable samples at each visit are included. Participants who have tested positive for SARS-CoV-2 via PCR or N-protein antibodies have their data included up to the point of positive test result or symptom onset. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. | PPI Set: Included all Phase 2b participants from the Immunogenicity Subset who received both doses as randomized and within the specified windows, had no important protocol deviations that impacted immunogenicity outcomes, did not receive medical treatments that interfered with the proposed immunogenicity measurements and had at least one blood sample collected at baseline and starting at 14 days post-second vaccination available for analysis. | Posted | Geometric Mean | 95% Confidence Interval | titers | Days 1 (baseline), 29, 43, 120 and 211 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Seroconverting to SARS-CoV-2 Viral Neutralizing Antibodies on Days 29, 43, 120 and 211 | Titers of viral neutralizing antibodies were determined by an activity assay. Percentage with 95% CI of participants for whom a seroconversion was observed is presented by group. In participants who tested seronegative to the N protein for SARS-CoV-2 at baseline, seroconversion was defined as a fold increase above 1 in antibody titer against SARS-CoV-2 neutralizing antibody titer. Only participants seronegative at baseline with evaluable samples at each visit are included. Participants who have tested positive for SARS-CoV-2 via PCR or N-protein antibodies have their data included up to the point of positive test result or symptom onset. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. | PPI Set: Included all Phase 2b participants from the Immunogenicity Subset who received both doses as randomized and within the specified windows, had no important protocol deviations that impacted immunogenicity outcomes, did not receive medical treatments that interfered with the proposed immunogenicity measurements and had at least one blood sample collected at baseline and starting at 14 days post-second vaccination available for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Days 29, 43, 120 and 211 |
|
Day 1 to Day 393
Participants who became unblinded and/or received a licensed/authorized vaccine were censored at the day after unblinding or at the day after receiving the licensed/authorized vaccine, whichever is earlier. All-cause mortality includes non-censored data.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CVnCoV 12 μg Vaccine | Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29. | 17 | 19,787 | 149 | 19,787 | 3,144 | 19,787 |
| EG001 | Placebo | Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29. | 14 | 19,753 | 111 | 19,753 | 1,853 | 19,753 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Complicated appendicitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Hantaviral infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Abscess intestinal | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Bartholin's abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Haemorrhagic fever with renal syndrome | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Oophoritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pelvic infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Q fever | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Salpingitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Accident | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Avulsion fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Laryngeal injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Vascular access site haematoma | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Ovarian germ cell teratoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Malignant neoplasm of thymus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Metastases to pleura | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Neurofibrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Phaeochromocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Retroperitoneal neoplasm metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Teratoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Systematic Assessment |
| |
| Pregnancy with injectable contraceptive | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Systematic Assessment |
| |
| Pregnancy on oral contraceptive | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Systematic Assessment |
| |
| Pregnancy on contraceptive | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Systematic Assessment |
| |
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Systematic Assessment |
| |
| Abortion incomplete | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Systematic Assessment |
| |
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Systematic Assessment |
| |
| Imminent abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Silent myocardial infarction | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Carotid sinus syndrome | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cerebral ventricle dilatation | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cervical radiculopathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Complex regional pain syndrome | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Multifocal motor neuropathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neuromyelitis optica spectrum disorder | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Peripheral nerve paresis | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Radial nerve palsy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Status migrainosus | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Thalamic infarction | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Colitis microscopic | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Malocclusion | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Peptic ulcer haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Biliary cyst | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gallbladder polyp | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Plica syndrome | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| IgA nephropathy | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Mixed anxiety and depressive disorder | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Self-injurious ideation | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Superficial vein thrombosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Bartholin's cyst | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fallopian tube cyst | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hydrosalpinx | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Normocytic anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Splenic infarction | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Optic nerve disorder | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Basedow's disease | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| HIV test positive | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pelvi-ureteric obstruction | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Information | CureVac AG | 0049 6976805870 | clinicaltrials@curevac.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 10, 2022 | Dec 8, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000722934 | CVnCoV COVID-19 vaccine |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian Indian |
|
| Chinese |
|
| Filipino |
|
| Japanese |
|
| Korean |
|
| Vietnamese |
|
| American Indian or Alaska Native |
|
| Other |
|
| Not Reported |
|
| Unknown |
|
Vaccine efficacy (VE) calculated as VE = 1 - p/(1-p) *1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group. |
| Exact Binomial Test |
| 0.01600 |
1-sided p-value from the exact binomial test on proportion of cases coming from the CVnCoV group among all cases (equivalent to a test on VE with H0: VE ≤30%). Statistically significant if lower than 0.02087. |
| Vaccine Efficacy |
| 48.2 |
| 2-Sided |
| 95.826 |
| 31.0 |
| 61.4 |
2-sided 95.826% CI on VE, derived from the exact 2-sided 95.826% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases. |
| Other |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG001 | Placebo | Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29. |
|
|
|
| OG001 |
| Placebo |
Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29. |
|
|
|
Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29. |
| OG001 | Placebo | Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29. |
|
|
|
|
|
|
|
|
|
|
| OG001 | Placebo | Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29. |
|
|
| OG001 | Placebo | Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29. |
|
|
Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29.
|
|
| OG001 | Placebo | Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29. |
|
|
| Moderate (Grade 2) |
|
| Severe (Grade 3) |
|