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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002856-10 | EudraCT Number |
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The primary objective of this clinical study is to assess the safety, and reactogenicity of CV7202 mRNA-rabies vaccine in healthy adults. Immunogenicity is also assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rabipur® | Active Comparator | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. |
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| CV7202 1 mcg | Experimental | Participants received messenger ribonucleic acid (mRNA) CV7202 1 microgram (mcg) intramuscular injection at Day 1, of whom half of the participants received a second dose of CV7202 1 mcg at Day 29. |
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| CV7202 2 mcg | Experimental | Participants received mRNA CV7202 2 mcg intramuscular injection at Day 1, of whom half of the participants received a second dose of CV7202 2 mcg at Day 29. |
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| CV7202 5 mcg | Experimental | Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rabipur® | Biological | 3 doses administered IM at Days 1, 8 and 29 in the deltoid region of the arm |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced a Local Solicited Adverse Event (AE) Post Dose 1 (Day 1) | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in a diary by the participant. | From the first dose of vaccination up to 7 days after vaccination (up to Day 8) |
| Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. The intensity of local solicited AEs was graded as:Pain at injection site(Grade 0:absent,Grade 1:Does not interfere with activity, Grade 2:Interferes with activity/repeated use of non-narcotic pain reliever greater than [>] 24 hours,Grade 3:prevent daily activity/repeated use of narcotic pain reliever); Redness(Grade 0:less than or equal to [<=]2.5 centimeters(cm), Grade 1:2.5 to 5cm,Grade 2: 5.1 to 10cm, Grade 3: >10cm);Swelling(Grade 0: <=2.5 cm,Grade 1: 2.5 to 5cm and does not interfere with activity,Grade 2:5.1 to 10cm/interferes with activity,Grade 3:>10cm or prevents daily activity);Itching(Grade 0:absent,Grade 1:Mild,no interference with normal activity,Grade 2:Moderate,some interference with normal activity,Grade 3:Significant, prevents normal activity). | From the first dose of vaccination up to 7 days after vaccination (up to Day 8) |
| Number of Participants Who Experienced a Systemic Solicited AE and Related Systemic Solicited AE Post Dose 1 (Day 1) | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia, and arthralgia on the day of vaccination and following 7 days after dose 1. All AEs were documented in diary by the participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Related SAEs From 12 Months Post-vaccination up to 24 Months | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. SAE was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect. Vaccine-related SAEs was included as SAEs for which there is evidence to suggest a causal relationship between the study product and the adverse event. |
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Inclusion criteria: Subjects must satisfy the following criteria at trial entry:
Exclusion Criteria Any trial subject who meets any of the following criteria will not qualify for entry into the trial
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | 9000 | Belgium | |||
| Department of Infectious Diseases and Tropical Medicine (DITM), Medical Center of the University of Munich |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33487468 | Derived | Aldrich C, Leroux-Roels I, Huang KB, Bica MA, Loeliger E, Schoenborn-Kellenberger O, Walz L, Leroux-Roels G, von Sonnenburg F, Oostvogels L. Proof-of-concept of a low-dose unmodified mRNA-based rabies vaccine formulated with lipid nanoparticles in human volunteers: A phase 1 trial. Vaccine. 2021 Feb 22;39(8):1310-1318. doi: 10.1016/j.vaccine.2020.12.070. Epub 2021 Jan 22. |
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A total 90 participants were screened, out of which 53 were enrolled and received the treatment.
The study was conducted at 2 investigative sites in Germany and Belgium between 12 October 2018 and 23 November 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | CV7202 1 mcg | Participants received messenger ribonucleic acid (mRNA) CV7202 1 microgram (mcg) intramuscular injection at Day 1, of whom half of the participants received a second dose of CV7202 1 mcg at Day 29. |
| FG001 | CV7202 2 mcg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 30, 2020 | Nov 24, 2022 |
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| Rabies mRNA vaccine CV7202 | Biological | CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm |
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| Rabies mRNA vaccine CV7202 | Biological | CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm |
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| Rabies mRNA vaccine CV7202 | Biological | CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm |
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| From the first dose of vaccination up to 7 days after vaccination (up to Day 8) |
| Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | The intensity of Systemic AEs was graded as: Fever(Grade 0: <38 degree Celsius (°C), Grade 1: >=38°C to 38.4°C, Grade 2:>=38.5°C to 38.9°C, Grade 3: >=39°C); Headache(Grade 0: absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Fatigue(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Chills(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Myalgia(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Arthralgia(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Nausea/Vomiting(Grade 0: Absent, Grade 1: Mild, no interference with activity/1-2 episodes/24 hours, Grade 2: Moderate, some interference with activity/>2 episodes/ 24 hours, Grade 3: Severe, prevents daily activity, requires outpatient intravenous [IV] hydration); Diarrhea(Grade 0: Absent, Grade 1: 2-3 stools, Grade 2: 4-5 stools, Grade 3: 6 or more watery stools or requires outpatient IV hydration). | From the first dose of vaccination up to 7 days after vaccination (up to Day 8) |
| Number of Days of Local Solicited AEs Post Dose 1 (Day 1) | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in diary by the participant. | From Day 1 (post-dose 1) to Day 8 |
| Number of Days of Local Solicited AEs Post Dose 2 | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in diary by the participant. | CV7202: From Day 29 (post-dose 2) to Day 36; Rabipur: Day 8 (post-dose 2) to Day 15 |
| Number of Days of Local Solicited AEs Post Dose 3 | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in diary by the participant. | Day 29 (post-dose 3) to Day 36 |
| Number of Days of Systemic Solicited AEs Post Dose 1 | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, chills, diarrhea, headache, fatigue, myalgia, and arthralgia. All AEs were documented in diary by the participant. | From Day 1 (post-dose 1) to Day 8 |
| Number of Days of Systemic Solicited AEs Post Dose 2 | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, diarrhea, chills, headache, fatigue, myalgia, and arthralgia. All AEs were documented in diary by the participant. | CV7202: From Day 29 (post-dose 2) to Day 36; Rabipur: Day 8 (post-dose 2) to Day 15 |
| Number of Days of Systemic Solicited AEs Post Dose 3 | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia, and arthralgia. All AEs were documented in diary by the participant. | Day 29 (post-dose 3) to Day 36 |
| Number of Participants Who Experienced Unsolicited and Related Unsolicited AEs | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. An unsolicited AE was defined as any other AE reported by the participant via diary cards or during study visits on the day of vaccination and the 28 subsequent days. The number of participants with unsolicited and related unsolicited AEs were reported. | From the first dose of vaccination up to 28 days after vaccination (up to Day 29) |
| Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. An unsolicited AE was defined as any other AE reported by the participant via diary cards or during study visits on the day of vaccination and the 28 subsequent days. The intensity of AEs was graded as: 1) Mild (Grade 1): An event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities.; 2) Moderate (Grade 2): An event that caused sufficient discomfort to interfere with normal everyday activities.; 3) Severe (Grade 3): An event that prevented normal everyday activities. Number of participants with Grade 1, 2 and 3 unsolicited and related unsolicited AEs were reported. | From the first dose of vaccination up to 28 days after vaccination (up to Day 29) |
| Number of Participants With Any Serious Adverse Events (SAEs) up to 12 Months | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. SAE was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect. | From the first dose of vaccination up to 12 months |
| Number of Participants With Any Medically-attended AEs (MAAEs) up to 12 Months | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Vaccine-related MAAEs include any AEs for which the participant received medical attention, defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason for which there is evidence to suggest a causal relationship between the study product and the adverse event. Number of participants with any MAAEs were reported. | From the first dose of vaccination up to 12 months |
| Number of Participants With Any Adverse Events of Special Interest (AESIs) and Related AESI up to 12 Month | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. AEs with a suspected potential immune-mediated disease etiology was considered as AESIs. AESI was assessed by the investigator. Vaccine-related AESIs was included as AESIs for which there was evidence to suggest a causal relationship between the study product and the adverse event. | From the first dose of vaccination up to 12 months |
| From 12 months up to 24 months |
| Number of Participants With Related MAAEs From 12 Months up to 24 Months | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Vaccine-related MAAEs include any AEs for which the participant received medical attention, defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason for which there is evidence to suggest a causal relationship between the study product and the adverse event. Number of participants with related MAAEs were reported. | From 12 months up to 24 months |
| Number of Participants With Any Related AESIs From 12 Months up to 24 Months | An AE was defined as any untoward medical occurrence in a clinical study participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. AEs with a suspected potential immune-mediated disease etiology was considered as AESIs. AESI was assessed by the investigator. Vaccine-related AESIs was included as AESIs for which there was evidence to suggest a causal relationship between the study product and the adverse event. Number of participants with any related AESIs were reported. | From 12 months up to 24 months |
| Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Rabies-specific serum response was defined as VNT ≥ 0.5 international units per milliliter (IU/mL). Rabies-specific serum VNT were measured using the WHO-recommended rapid fluorescent foci inhibition test (RFFIT). Serial dilutions of each serum sample are mixed with a standard dose of rabies virus before tissue culture cells are added. Virus infected cells are detected via a fluorochrome conjugated rabies-specific antibody. If the serum contains antibodies that bind and neutralize the virus, the infectivity of the virus is reduced. The virus neutralization end-point titer is defined as the highest sample dilution at which 50% of the observed microscopic fields contain ≥ 1 infected cell. The percentages of participants with rabies-specific serum VNTs ≥0.5 were taken as positive and were reported. | Baseline (Day 1), Days 15, 43, 365, 547, and 730 |
| Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Serum geometric mean titer (antilog mean of log-transformed VNTs) was obtained from measuring VNTs using the WHO-recommended rapid fluorescent foci inhibition test. The virus neutralization end-point titer (VNT) is defined as the highest sample dilution at which 50% of the observed microscopic fields contain >=1 infected cell. | Baseline (Day 1), Days 8, 15, 29, 36, 43, 57, 91, 182, 365, 547, and 730 |
| Munich |
| Bavaria |
| 80802 |
| Germany |
Participants received mRNA CV7202 2 mcg intramuscular injection at Day 1, of whom half of the participants received a second dose of CV7202 2 mcg at Day 29.
| FG002 | CV7202 5 mcg | Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. |
| FG003 | Rabipur® | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. |
| Received Dose at Day 1 |
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| Received Dose at Day 8 |
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| Received Dose at Day 29 |
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| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data.
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| ID | Title | Description |
|---|---|---|
| BG000 | CV7202 1 mcg | Participants received mRNA CV7202 1 mcg intramuscular injection at Day 1, of whom half of the participants received a second dose of CV7202 1 mcg at Day 29. |
| BG001 | CV7202 2 mcg | Participants received mRNA CV7202 2 mcg intramuscular injection at Day 1, of whom half of the participants received a second dose of CV7202 2 mcg at Day 29. |
| BG002 | CV7202 5 mcg | Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. |
| BG003 | Rabipur® | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||
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| Primary | Number of Participants Who Experienced a Local Solicited Adverse Event (AE) Post Dose 1 (Day 1) | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in a diary by the participant. | Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data. | Posted | Count of Participants | Participants | From the first dose of vaccination up to 7 days after vaccination (up to Day 8) |
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| Primary | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. The intensity of local solicited AEs was graded as:Pain at injection site(Grade 0:absent,Grade 1:Does not interfere with activity, Grade 2:Interferes with activity/repeated use of non-narcotic pain reliever greater than [>] 24 hours,Grade 3:prevent daily activity/repeated use of narcotic pain reliever); Redness(Grade 0:less than or equal to [<=]2.5 centimeters(cm), Grade 1:2.5 to 5cm,Grade 2: 5.1 to 10cm, Grade 3: >10cm);Swelling(Grade 0: <=2.5 cm,Grade 1: 2.5 to 5cm and does not interfere with activity,Grade 2:5.1 to 10cm/interferes with activity,Grade 3:>10cm or prevents daily activity);Itching(Grade 0:absent,Grade 1:Mild,no interference with normal activity,Grade 2:Moderate,some interference with normal activity,Grade 3:Significant, prevents normal activity). | Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data. | Posted | Count of Participants | Participants | From the first dose of vaccination up to 7 days after vaccination (up to Day 8) |
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| Primary | Number of Participants Who Experienced a Systemic Solicited AE and Related Systemic Solicited AE Post Dose 1 (Day 1) | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia, and arthralgia on the day of vaccination and following 7 days after dose 1. All AEs were documented in diary by the participant. | Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data. | Posted | Count of Participants | Participants | From the first dose of vaccination up to 7 days after vaccination (up to Day 8) |
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| Primary | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | The intensity of Systemic AEs was graded as: Fever(Grade 0: <38 degree Celsius (°C), Grade 1: >=38°C to 38.4°C, Grade 2:>=38.5°C to 38.9°C, Grade 3: >=39°C); Headache(Grade 0: absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Fatigue(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Chills(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Myalgia(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Arthralgia(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Nausea/Vomiting(Grade 0: Absent, Grade 1: Mild, no interference with activity/1-2 episodes/24 hours, Grade 2: Moderate, some interference with activity/>2 episodes/ 24 hours, Grade 3: Severe, prevents daily activity, requires outpatient intravenous [IV] hydration); Diarrhea(Grade 0: Absent, Grade 1: 2-3 stools, Grade 2: 4-5 stools, Grade 3: 6 or more watery stools or requires outpatient IV hydration). | Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data. | Posted | Count of Participants | Participants | From the first dose of vaccination up to 7 days after vaccination (up to Day 8) |
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| Primary | Number of Days of Local Solicited AEs Post Dose 1 (Day 1) | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in diary by the participant. | Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who had an event in the respective category (pain, redness). | Posted | Median | Full Range | Days | From Day 1 (post-dose 1) to Day 8 |
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| Primary | Number of Days of Local Solicited AEs Post Dose 2 | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in diary by the participant. | Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who had an event in the respective category (pain, redness). | Posted | Median | Full Range | Days | CV7202: From Day 29 (post-dose 2) to Day 36; Rabipur: Day 8 (post-dose 2) to Day 15 |
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| Primary | Number of Days of Local Solicited AEs Post Dose 3 | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in diary by the participant. | Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who had an event in the respective category (pain, redness). | Posted | Median | Full Range | Days | Day 29 (post-dose 3) to Day 36 |
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| Primary | Number of Days of Systemic Solicited AEs Post Dose 1 | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, chills, diarrhea, headache, fatigue, myalgia, and arthralgia. All AEs were documented in diary by the participant. | Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who had an event in the respective category (temperature, headache, fatigue, chils, myalgia, arthralgia, nausea/vomiting, diarrhea). | Posted | Median | Full Range | Days | From Day 1 (post-dose 1) to Day 8 |
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| Primary | Number of Days of Systemic Solicited AEs Post Dose 2 | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, diarrhea, chills, headache, fatigue, myalgia, and arthralgia. All AEs were documented in diary by the participant. | Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who had an event in the respective category (temperature,headache, fatigue, chills, myalgia, arthralgia, nausea/ vomiting, diarrhea). | Posted | Median | Full Range | Days | CV7202: From Day 29 (post-dose 2) to Day 36; Rabipur: Day 8 (post-dose 2) to Day 15 |
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| Primary | Number of Days of Systemic Solicited AEs Post Dose 3 | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia, and arthralgia. All AEs were documented in diary by the participant. | Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who had an event in the respective category (headache, fatigue, chills). | Posted | Median | Full Range | Days | Day 29 (post-dose 3) to Day 36 |
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| Primary | Number of Participants Who Experienced Unsolicited and Related Unsolicited AEs | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. An unsolicited AE was defined as any other AE reported by the participant via diary cards or during study visits on the day of vaccination and the 28 subsequent days. The number of participants with unsolicited and related unsolicited AEs were reported. | Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data. | Posted | Count of Participants | Participants | From the first dose of vaccination up to 28 days after vaccination (up to Day 29) |
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| Primary | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. An unsolicited AE was defined as any other AE reported by the participant via diary cards or during study visits on the day of vaccination and the 28 subsequent days. The intensity of AEs was graded as: 1) Mild (Grade 1): An event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities.; 2) Moderate (Grade 2): An event that caused sufficient discomfort to interfere with normal everyday activities.; 3) Severe (Grade 3): An event that prevented normal everyday activities. Number of participants with Grade 1, 2 and 3 unsolicited and related unsolicited AEs were reported. | Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data. Here overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed included those participants who were evaluable for the specified categories for this outcome measure. | Posted | Count of Participants | Participants | From the first dose of vaccination up to 28 days after vaccination (up to Day 29) |
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| Primary | Number of Participants With Any Serious Adverse Events (SAEs) up to 12 Months | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. SAE was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect. | Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data. | Posted | Count of Participants | Participants | From the first dose of vaccination up to 12 months |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Any Medically-attended AEs (MAAEs) up to 12 Months | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Vaccine-related MAAEs include any AEs for which the participant received medical attention, defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason for which there is evidence to suggest a causal relationship between the study product and the adverse event. Number of participants with any MAAEs were reported. | Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data. | Posted | Count of Participants | Participants | From the first dose of vaccination up to 12 months |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Any Adverse Events of Special Interest (AESIs) and Related AESI up to 12 Month | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. AEs with a suspected potential immune-mediated disease etiology was considered as AESIs. AESI was assessed by the investigator. Vaccine-related AESIs was included as AESIs for which there was evidence to suggest a causal relationship between the study product and the adverse event. | Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data. | Posted | Count of Participants | Participants | From the first dose of vaccination up to 12 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Related SAEs From 12 Months Post-vaccination up to 24 Months | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. SAE was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect. Vaccine-related SAEs was included as SAEs for which there is evidence to suggest a causal relationship between the study product and the adverse event. | Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data. | Posted | Count of Participants | Participants | From 12 months up to 24 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Related MAAEs From 12 Months up to 24 Months | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Vaccine-related MAAEs include any AEs for which the participant received medical attention, defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason for which there is evidence to suggest a causal relationship between the study product and the adverse event. Number of participants with related MAAEs were reported. | Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data. | Posted | Count of Participants | Participants | From 12 months up to 24 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Related AESIs From 12 Months up to 24 Months | An AE was defined as any untoward medical occurrence in a clinical study participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. AEs with a suspected potential immune-mediated disease etiology was considered as AESIs. AESI was assessed by the investigator. Vaccine-related AESIs was included as AESIs for which there was evidence to suggest a causal relationship between the study product and the adverse event. Number of participants with any related AESIs were reported. | Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data. | Posted | Count of Participants | Participants | From 12 months up to 24 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Rabies-specific serum response was defined as VNT ≥ 0.5 international units per milliliter (IU/mL). Rabies-specific serum VNT were measured using the WHO-recommended rapid fluorescent foci inhibition test (RFFIT). Serial dilutions of each serum sample are mixed with a standard dose of rabies virus before tissue culture cells are added. Virus infected cells are detected via a fluorochrome conjugated rabies-specific antibody. If the serum contains antibodies that bind and neutralize the virus, the infectivity of the virus is reduced. The virus neutralization end-point titer is defined as the highest sample dilution at which 50% of the observed microscopic fields contain ≥ 1 infected cell. The percentages of participants with rabies-specific serum VNTs ≥0.5 were taken as positive and were reported. | Full analysis set (FAS) is a subset of the safety set with participants who had the baseline sample and at least 1 additional blood sample available for VNT analysis. Here overall number of participants analyzed included those participants who were evaluable for this outcome measure and number analyzed included those participants who were evaluable at specified timepoints for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Day 1), Days 15, 43, 365, 547, and 730 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Serum geometric mean titer (antilog mean of log-transformed VNTs) was obtained from measuring VNTs using the WHO-recommended rapid fluorescent foci inhibition test. The virus neutralization end-point titer (VNT) is defined as the highest sample dilution at which 50% of the observed microscopic fields contain >=1 infected cell. | FAS is a subset of the safety set with participants who had the baseline sample and at least 1 additional blood sample available for VNT analysis. Here overall number of participants analyzed included those participants who were evaluable for this outcome measure and number analyzed included those participants who were evaluable at specified timepoints for this outcome measure. | Posted | Geometric Mean | Standard Deviation | IU/mL | Baseline (Day 1), Days 8, 15, 29, 36, 43, 57, 91, 182, 365, 547, and 730 |
|
From the first dose of vaccination up to 24 months
Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety 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 | CV7202 1 mcg | Participants received mRNA CV7202 1 mcg intramuscular injection at Day 1, of whom half of the participants received a second dose of CV7202 1 mcg at Day 29. | 0 | 16 | 1 | 16 | 14 | 16 |
| EG001 | CV7202 2 mcg | Participants received mRNA CV7202 2 mcg intramuscular injection at Day 1, of whom half of the participants received a second dose of CV7202 2 mcg at Day 29. | 0 | 16 | 0 | 16 | 14 | 16 |
| EG002 | CV7202 5 mcg | Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. | 0 | 10 | 0 | 10 | 10 | 10 |
| EG003 | Rabipur® | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. | 0 | 11 | 1 | 11 | 8 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes zoster | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Chlamydial infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Epstein-Barr virus infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Strongyloidiasis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tonsillitis streptococcal | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tremor | Nervous system 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 |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abnormal faeces | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tongue discomfort | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vessel puncture site pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lactose intolerance | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oligodipsia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Allergy to animal | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Allergy to arthropod bite | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Mite allergy | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Menstruation delayed | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CureVac SE | CureVac | +49 (0) 697680587-0 | clinicaltrials@curevac.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2022 | Nov 24, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Germany |
|
| CV7202 2 mcg |
Participants received mRNA CV7202 2 mcg intramuscular injection at Day 1, of whom half of the participants received a second dose of CV7202 2 mcg at Day 29. |
| OG002 | CV7202 5 mcg | Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. |
| OG003 | Rabipur® | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. |
|
|
Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. |
| OG003 | Rabipur® | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. |
|
|
| CV7202 2 mcg |
Participants received mRNA CV7202 2 mcg intramuscular injection at Day 1, of whom half of the participants received a second dose of CV7202 2 mcg at Day 29. |
| OG002 | CV7202 5 mcg | Participants received mRNA CV7202 5 mcg intramuscular dose at Day 1. |
| OG003 | Rabipur® | Participants received 3 doses of Rabipur® intramuscularly at Days 1, 8 and 29 according to the manufacturer's recommendations. |
|
|
Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. |
| OG003 | Rabipur® | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. |
|
|
| OG002 | Rabipur® | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. |
|
|
|
| CV7202 5 mcg |
Participants received mRNA CV7202 5 mcg intramuscular dose at Day 1. |
| OG003 | Rabipur® | Participants received 3 doses of Rabipur® intramuscularly at Days 1, 8 and 29 according to the manufacturer's recommendations. |
|
|
| OG002 | Rabipur® | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. |
|
|
|
Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. |
| OG003 | Rabipur® | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. |
|
|
| OG001 | CV7202 2 mcg | Participants received mRNA CV7202 2 mcg intramuscular injection at Day 1, of whom half of the participants received a second dose of CV7202 2 mcg at Day 29. |
| OG002 | CV7202 5 mcg | Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. |
| OG003 | Rabipur® | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. |
|
|
Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. |
| OG003 | Rabipur® | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. |
|
|
| CV7202 5 mcg |
Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. |
| OG003 | Rabipur® | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. |
|
|
Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. |
| OG003 | Rabipur® | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. |
|
|
| OG002 | CV7202 5 mcg | Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. |
| OG003 | Rabipur® | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. |
|
|
| CV7202 5 mcg |
Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. |
| OG003 | Rabipur® | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. |
|
|
Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. |
| OG003 | Rabipur® | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. |
|
|
| OG001 |
| CV7202 2 mcg |
Participants received mRNA CV7202 2 mcg intramuscular injection at Day 1, of whom half of the participants received a second dose of CV7202 2 mcg at Day 29. |
| OG002 | CV7202 5 mcg | Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. |
| OG003 | Rabipur® | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. |
|
|
Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. |
| OG003 | Rabipur® | Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. |
|
|
| Grade 1 (Mild) |
|
| Grade 2 (Moderate) |
|
| Grade 3 (Severe) |
|
| Not assessed |
|
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| Title | Measurements |
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| Grade 2 (Moderate) |
|
| Grade 3 (Severe) |
|
|
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