A Phase 2/3 interventional study of CVnCoV and Placebo in Covid19 and SARS-CoV-2, sponsored by CureVac. Completed at 46 sites in 10 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-29.
Sponsored by CureVac (part of BioNTech SE) · Phase 2/3, Interventional, and Prevention
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.).
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 39,680 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →CureVac is the lead sponsor of 18 studies on the registry; none are open to participants now.
First submitted before CureVac became part of BioNTech SE.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Females of childbearing potential must use highly effective methods of 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: CVnCoV
Participants will be administered the matching placebo on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
Biological: Placebo
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.
Biological: CVnCoV
Participants will be administered the matching placebo on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
Biological: Placebo
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.
Biological: Authorized/licensed vaccines for preventing COVID-19 (AV) as standard of care through their national vaccination program
Intramuscular (IM) injection.
Also known as: CV07050101
Intramuscular (IM) injection.
Intramuscular (IM) injection will be received as standard of care (SoC) outside the study.
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: * Virologically-confirmed case of COVID-19 (of any severity) defined as a positive SARS-CoV-2 specific RT-PCR test in a person with clinically symptomatic COVID-19. * Symptom onset ≥ 15 days after second trial vaccination. * First episode of virologically-confirmed COVID-19, i.e. the participant must not have had a history of virologically-confirmed COVID-19 illness at enrollment or have had developed a case of virologically-confirmed COVID-19 before 15 days after the second trial vaccination. * Participant was SARS-CoV-2 naïve at baseline and Day 43 (defined as seronegative to N protein in the blood samples collected at baseline and Day 43). * Primary efficacy cases were confirmed by an Adjudication Committee. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Time frame: 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.
Time frame: 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: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event. 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.
Time frame: 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: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event. 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.
Time frame: Day 1 to Day 393
Number of Participants Who Experienced One or More Adverse Event of Special Interest (AESI)
AESIs included: * AEs with a suspected immune-medicated etiology. * Other AEs relevant to SARS-CoV-2 vaccine development or the target disease. 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 to Day 393
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: * Shortness of breath/difficulty breathing * Respiratory rate ≥20 to \<30 breaths per min * Abnormal SpO2 but still \>93% on room air at sea level * Clinical/radiographic evidence of lower respiratory tract disease * Radiologic evidence of DVT Severe cases defined by any 1 of the following: * Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30breaths per minute, heart rate ≥125 per minute, SpO2 ≤93% on room air at sea level or PaO2/FIO2 \<300 mm Hg) * Respiratory failure (defined as needing high flow-oxygen, noninvasive ventilation, mechanical ventilation or ECMO) * Evidence of shock (SBP \<90mm Hg, DBP \<60 mmHg or requiring vasopressors) * Significant renal, hepatic, or neurologic dysfunction * Admission to ICU * Death Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Time frame: 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: * Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 per minute, SpO2 ≤ 93% on room air at sea level or PaO2/FIO2 \< 300 mm Hg). * Respiratory failure (defined as needing high flow-oxygen, noninvasive ventilation, mechanical ventilation or ECMO). * Evidence of shock (SBP \< 90mm Hg, DBP \< 60 mmHg, or requiring vasopressors). * Significant renal, hepatic, or neurologic dysfunction * Admission to intensive care unit (ICU). * Death. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Time frame: 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: 1. "Wild type" virus: WT/D614G, lineages A.1/B.1 without the variant of concerns (VOCs) (i.e., without B.1.1.7 \[Alpha\], B.1.351 \[Beta\], B.1.429 \[Epsilon\]). 2. "UK" VOC: B.1.1.7 (Alpha). A case of COVID-19 was defined as follows: * Virologically-confirmed case of COVID-19 defined as a positive SARS-CoV-2 specific RT-PCR test in a person with clinically symptomatic COVID-19. * Symptom onset ≥ 15 days after second vaccination. * First episode of virologically-confirmed COVID-19. * Participant was SARS-CoV-2 naïve at baseline and Day 43. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Time frame: 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: * Virologically-confirmed case of COVID-19 (of any severity) defined as a positive SARS-CoV-2 specific RT-PCR test in a person with clinically symptomatic COVID-19. * Symptom onset ≥ 15 days after second trial vaccination. * First episode of virologically-confirmed COVID-19, i.e. the participant must not have had a history of virologically-confirmed COVID-19 illness at enrollment or have had developed a case of virologically-confirmed COVID-19 before 15 days after the second trial vaccination. * Participant was SARS-CoV-2 naïve at baseline and Day 43 (defined as seronegative to N protein in the blood samples collected at baseline and Day 43). Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Days 29, 43, 120 and 211
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.
| Milestone | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Started | 19787 | 19753 |
| Phase 2b participants | 2007 | 1987 |
| Phase 3 participants | 17780 | 17766 |
| Rolled over to open-label phase | 8513 | 0 |
| Completed | 11451 | 4161 |
| Not completed | 8336 | 15592 |
| Withdrew: Adverse event | 14 | 13 |
| Withdrew: Subject received alternative authorised vaccine | 1407 | 6552 |
| Withdrew: Physician decision | 78 | 40 |
| Withdrew: Study ended by sponsor | 64 | 17 |
| Withdrew: Withdrawal by subject | 4625 | 5594 |
| Withdrew: Lost to follow-up | 2019 | 1082 |
| Withdrew: Protocol specified withdrawal criterion met | 49 | 2230 |
| Withdrew: Miscellaneous | 80 | 64 |
A case of COVID-19 meeting the definition for primary efficacy analysis was defined as follows: * Virologically-confirmed case of COVID-19 (of any severity) defined as a positive SARS-CoV-2 specific RT-PCR test in a person with clinically symptomatic COVID-19. * Symptom onset ≥ 15 days after second trial vaccination. * First episode of virologically-confirmed COVID-19, i.e. the participant must not have had a history of virologically-confirmed COVID-19 illness at enrollment or have had developed a case of virologically-confirmed COVID-19 before 15 days after the second trial vaccination. * Participant was SARS-CoV-2 naïve at baseline and Day 43 (defined as seronegative to N protein in the blood samples collected at baseline and Day 43). * Primary efficacy cases were confirmed by an Adjudication Committee. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
| Participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| 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 | 83 | 145 |
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.
| Participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Any Medically-attended AE | 2555 | 2084 |
| Any Related Medically-attended AE | 505 | 138 |
An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event. 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.
| Participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Any SAE | 149 | 111 |
| Any Related SAE | 8 | 1 |
An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event. 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.
| Participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Mild (Grade 1) | 21 | 10 |
| Moderate (Grade 2) | 50 | 35 |
| Severe (Grade 3) | 74 | 66 |
| Missing | 4 | 0 |
AESIs included: * AEs with a suspected immune-medicated etiology. * Other AEs relevant to SARS-CoV-2 vaccine development or the target disease. 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.
| Participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Any AESI | 64 | 47 |
| Any Related AESI | 19 | 5 |
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.
| Participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Number of Participants Who Experienced a Fatal SAE | 11 | 12 |
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.
| Participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Any Solicited Local AE | 1699 | 477 |
| Any Solicited Systemic AE | 1881 | 1255 |
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.
| Participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Any Solicited Local AEs — Mild (Grade 1) | 1226 | 452 |
| Any Solicited Local AEs — Moderate (Grade 2) | 448 | 24 |
| Any Solicited Local AEs — Severe (Grade 3) | 25 | 1 |
| Any Solicited Systemic AEs — Mild (Grade 1) | 376 | 708 |
| Any Solicited Systemic AEs — Moderate (Grade 2) | 969 | 487 |
| Any Solicited Systemic AEs — Severe (Grade 3) | 536 | 60 |
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.
| days | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Solicited Local AEs - Injection Site Pain | 2.3 ± 1.24 | 1.5 ± 1.24 |
| Solicited Local AEs - Redness | 2.2 ± 2.32 | 2.1 ± 1.99 |
| Solicited Local AEs - Swelling | 1.7 ± 0.97 | 1.2 ± 0.56 |
| Solicited Local AEs - Itching | 1.6 ± 1.20 | 1.4 ± 1.42 |
| Solicited Systemic AEs - Fever | 1.3 ± 0.52 | 1.0 ± 0.00 |
| Solicited Systemic AEs - Headache | 2.0 ± 1.41 | 1.8 ± 2.45 |
| Solicited Systemic AEs - Fatigue | 2.3 ± 2.84 | 2.0 ± 2.25 |
| Solicited Systemic AEs - Chills | 1.3 ± 0.67 | 1.4 ± 0.83 |
| Solicited Systemic AEs - Myalgia | 1.8 ± 1.08 | 1.6 ± 1.13 |
| Solicited Systemic AEs - Arthralgia | 1.6 ± 0.98 | 1.6 ± 1.19 |
| Solicited Systemic AEs - Nausea/Vomiting | 1.5 ± 0.97 | 1.3 ± 0.82 |
| Solicited Systemic AEs - Diarrhea | 1.4 ± 0.95 | 1.3 ± 0.90 |
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.
| Participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Any Unsolicited AE | 1016 | 911 |
| Any Related Unsolicited AE | 511 | 269 |
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.
| Participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Mild (Grade 1) | 712 | 641 |
| Moderate (Grade 2) | 259 | 225 |
| Severe (Grade 3) | 44 | 38 |
| Missing | 1 | 7 |
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
| Participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Any AE Leading to Vaccine Withdrawal | 32 | 33 |
| Any AE Leading to Withdrawal From Trial | 17 | 16 |
Moderate cases defined by any 1 of the following: * Shortness of breath/difficulty breathing * Respiratory rate ≥20 to \<30 breaths per min * Abnormal SpO2 but still \>93% on room air at sea level * Clinical/radiographic evidence of lower respiratory tract disease * Radiologic evidence of DVT Severe cases defined by any 1 of the following: * Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30breaths per minute, heart rate ≥125 per minute, SpO2 ≤93% on room air at sea level or PaO2/FIO2 \<300 mm Hg) * Respiratory failure (defined as needing high flow-oxygen, noninvasive ventilation, mechanical ventilation or ECMO) * Evidence of shock (SBP \<90mm Hg, DBP \<60 mmHg or requiring vasopressors) * Significant renal, hepatic, or neurologic dysfunction * Admission to ICU * Death Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
| Participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Moderate to Severe Case of COVID-19 | 12 | 37 |
Severe COVID-19 cases were defined by any one of the following: * Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 per minute, SpO2 ≤ 93% on room air at sea level or PaO2/FIO2 \< 300 mm Hg). * Respiratory failure (defined as needing high flow-oxygen, noninvasive ventilation, mechanical ventilation or ECMO). * Evidence of shock (SBP \< 90mm Hg, DBP \< 60 mmHg, or requiring vasopressors). * Significant renal, hepatic, or neurologic dysfunction * Admission to intensive care unit (ICU). * Death. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
| Participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Severe Case of COVID-19 | 4 | 10 |
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: 1. "Wild type" virus: WT/D614G, lineages A.1/B.1 without the variant of concerns (VOCs) (i.e., without B.1.1.7 \[Alpha\], B.1.351 \[Beta\], B.1.429 \[Epsilon\]). 2. "UK" VOC: B.1.1.7 (Alpha). A case of COVID-19 was defined as follows: * Virologically-confirmed case of COVID-19 defined as a positive SARS-CoV-2 specific RT-PCR test in a person with clinically symptomatic COVID-19. * Symptom onset ≥ 15 days after second vaccination. * First episode of virologically-confirmed COVID-19. * Participant was SARS-CoV-2 naïve at baseline and Day 43. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
| Participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| 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 | 29 | 56 |
A case of COVID-19 was defined as follows: * Virologically-confirmed case of COVID-19 (of any severity) defined as a positive SARS-CoV-2 specific RT-PCR test in a person with clinically symptomatic COVID-19. * Symptom onset ≥ 15 days after second trial vaccination. * First episode of virologically-confirmed COVID-19, i.e. the participant must not have had a history of virologically-confirmed COVID-19 illness at enrollment or have had developed a case of virologically-confirmed COVID-19 before 15 days after the second trial vaccination. * Participant was SARS-CoV-2 naïve at baseline and Day 43 (defined as seronegative to N protein in the blood samples collected at baseline and Day 43). Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
| Participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Number of Participants Aged ≥ 61 Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Case of COVID-19 of Any Severity | 12 | 9 |
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.
| Participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| 0 | 12768 | 12066 |
| 1 | 79 | 135 |
| 2 | 4 | 10 |
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.
| Participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| 0 | 12768 | 12066 |
| 1 | 82 | 143 |
| 2 | 0 | 2 |
| 3 | 1 | 0 |
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.
| titers | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Day 1 | 50.791 (50.151 to 51.439) | 50.763 (50.079 to 51.456) |
| Day 29 | 54.090 (52.213 to 56.034) | 50.734 (50.074 to 51.403) |
| Day 43 | 734.657 (645.552 to 836.061) | 50.902 (50.082 to 51.737) |
| Day 120 | 227.439 (203.647 to 254.011) | 57.357 (52.843 to 62.257) |
| Day 211 | 371.341 (161.098 to 855.966) | 107.556 (23.919 to 483.648) |
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.
| percentage of participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Day 29 | 4.3 (2.7 to 6.4) | 0.4 (0.0 to 1.4) |
| Day 43 | 87.1 (83.9 to 89.8) | 0.6 (0.1 to 1.8) |
| Day 120 | 72.2 (67.7 to 76.4) | 4.9 (2.6 to 8.4) |
| Day 211 | 66.7 (46.0 to 83.5) | 28.6 (3.7 to 71.0) |
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.
| titers | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Day 1 (Baseline) | 5.016 (4.993 to 5.039) | 5.007 (4.994 to 5.020) |
| Day 29 | 5.141 (5.022 to 5.263) | 5.030 (4.995 to 5.066) |
| Day 43 | 18.211 (16.394 to 20.230) | 5.049 (5.003 to 5.096) |
| Day 120 | 7.105 (6.640 to 7.603) | 5.136 (5.008 to 5.267) |
| Day 211 | 14.325 (7.183 to 28.565) | 6.729 (4.209 to 10.757) |
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.
| percentage of participants | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| Day 29 | 1.5 (0.6 to 2.9) | 0.6 (0.1 to 1.7) |
| Day 43 | 65.1 (60.8 to 69.2) | 1.0 (0.3 to 2.3) |
| Day 120 | 24.8 (20.8 to 29.1) | 2.0 (0.7 to 4.7) |
| Day 211 | 33.3 (16.5 to 54.0) | 28.6 (3.7 to 71.0) |
Collected over Day 1 to Day 393. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CVnCoV 12 μg Vaccine | 17/19,787 (0.1%) | 149/19,787 (0.8%) | 3,144/19,787 (15.9%) |
| Placebo | 14/19,753 (0.1%) | 111/19,753 (0.6%) | 1,853/19,753 (9.4%) |
| Event | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| AppendicitisInfections and infestations | 8/19787 | 3/19753 |
| COVID-19 pneumoniaInfections and infestations | 5/19787 | 4/19753 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 5/19787 | 0/19753 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/19787 | 4/19753 |
| NephrolithiasisRenal and urinary disorders | 1/19787 | 4/19753 |
| Pregnancy on oral contraceptivePregnancy, puerperium and perinatal conditions | 4/19787 | 0/19753 |
| Cholecystitis acuteHepatobiliary disorders | 4/19787 | 0/19753 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 4/19787 | 2/19753 |
| COVID-19Infections and infestations | 1/19787 | 3/19753 |
| Pregnancy with injectable contraceptivePregnancy, puerperium and perinatal conditions | 2/19787 | 3/19753 |
| Event | CVnCoV 12 μg Vaccine | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 2310/19787 | 1225/19753 |
| Injection site painGeneral disorders | 2008/19787 | 537/19753 |
| FatigueGeneral disorders | 1893/19787 | 1019/19753 |
| MyalgiaMusculoskeletal and connective tissue disorders | 1728/19787 | 509/19753 |
| ChillsGeneral disorders | 1439/19787 | 240/19753 |
| PyrexiaGeneral disorders | 1305/19787 | 95/19753 |
Safety Analysis Set: Included all participants randomized into Phase 2b or 3 who received at least one dose of CVnCoV or placebo.
| Age, Continuous(years) | CVnCoV 12 μg Vaccine | Placebo | Total |
|---|---|---|---|
| Mean | 43.0 ± 14.49 | 43.0 ± 14.50 | 43.0 ± 14.50 |
| Sex: Female, Male(Participants) | CVnCoV 12 μg Vaccine | Placebo | Total |
|---|---|---|---|
| Female | 8935 | 8936 | 17871 |
| Male | 10852 | 10817 | 21669 |
| Ethnicity (NIH/OMB)(Participants) | CVnCoV 12 μg Vaccine | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 14732 | 14740 | 29472 |
| Not Hispanic or Latino | 4960 | 4932 | 9892 |
| Unknown or Not Reported | 95 | 81 | 176 |
| Race/Ethnicity, Customized(Participants) | CVnCoV 12 μg Vaccine | Placebo | Total |
|---|---|---|---|
| Race — White | 9012 | 8989 | 18001 |
| Race — Black or African American | 383 | 356 | 739 |
| Race — Asian Indian | 18 | 10 | 28 |
| Race — Chinese | 21 | 22 | 43 |
| Race — Filipino | 1 | 3 | 4 |
| Race — Japanese | 5 | 0 | 5 |
| Race — Korean | 0 | 2 | 2 |
| Race — Vietnamese | 9 | 9 | 18 |
| Race — American Indian or Alaska Native | 2492 | 2485 | 4977 |
| Race — Other | 7797 | 7812 | 15609 |
| Race — Not Reported | 34 | 44 | 78 |
| Race — Unknown | 15 | 21 | 36 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2020 to primary completion in Jun 2022, 17 months.
Results were first posted in Apr 2024, 1 year 10 months after primary completion.
Of 73 industry-sponsored phase 2/3 interventional studies under COVID-19, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's 17 months is above that.
Counting every sponsor, half of 168 studies reached it within 11 months; a quarter within 5 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: CVnCoV COVID-19 vaccine