Rabies
Conditions
Keywords
Rabies, Vaccine, Safety, Reactogenicity, Immunogenicity
Brief summary
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.
Interventions
BIOLOGICALRabipur®
3 doses administered IM at Days 1, 8 and 29 in the deltoid region of the arm
BIOLOGICALRabies mRNA vaccine CV7202
CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm
Sponsors
CureVac
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects must satisfy the following criteria at trial entry: 1. Healthy male and female subjects aged 18 to 40 years inclusive. Healthy Subject is defined as an individual who is in good general health, not having any mental or physical disorder requiring regular or frequent medication. 2. Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. 3. Physical examination and laboratory results without clinically significant findings. 4. Body Mass Index (BMI) ≥18.0 and ≤32.0 kg/m2. 5. Females: At the time of screening, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrolment. On Day 1 (pre-vaccination): negative urine pregnancy test (hCG), (only required if the screening visit serum pregnancy test was performed more than 3 days before). 6. Females of childbearing potential must use acceptable methods of birth control from 2 weeks before the first administration of the test vaccine until 3 months following the last administration. 7. Males must use reliable forms of contraception (condom) from the moment of the first administration of the test vaccine until 3 months following the last administration and must refrain from sperm donation from the moment of the first administration of the test vaccine until 3 months after the last administration.
Exclusion criteria
Any trial subject who meets any of the following criteria will not qualify for entry into the trial 1. Use of any investigational or non-registered product (drug or vaccine) other than the trial vaccine within 4 weeks preceding the administration of the trial vaccine, or planned use during the trial period. 2. Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this trial or planned receipt of any vaccine within 28 days of any trial vaccine administration. 3. Receipt of any licensed or investigational rabies vaccine prior to the administration of the trial vaccine. 4. Planning to travel to regions/countries for which rabies vaccinations are recommended or where high risk of infection exists according to travel recommendations by the German Society of Tropical Medicine and International Health during the trial and up to the end of the trial. 5. Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the trial vaccine or planned use during the trial, with the exception of inhaled and nasal steroids, or topically-applied steroids. 6. Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) infection and hepatitis C virus (HCV) infection. 7. History of a potential immune mediated disease. 8. Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine. 9. Presence or evidence of significant acute or chronic, uncontrolled medical or psychiatric illness. 10. Known allergy to any component of CV7202 such as type I allergy to beta-lactam antibiotics or Rabipur®. 11. Evidence of current alcohol or drug abuse. 12. History of any neurological disorders or seizures including Guillain-Barré syndrome (GBS), with the exception of febrile seizures during childhood. 13. Foreseeable non-compliance with protocol as judged by the investigator. 14. For females: Pregnancy or lactation. 15. History of any life-threatening anaphylactic reactions. 16. Subjects with impaired coagulation or any bleeding disorder in whom an i.m. injection or a blood draw is contraindicated. 17. Known relatives of site research staff working on this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Events of Special Interest (AESIs) and Related AESI up to 12 Month | From the first dose of vaccination 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. 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 Days of Systemic Solicited AEs Post Dose 3 | Day 29 (post-dose 3) to Day 36 | 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. |
| Number of Participants Who Experienced Unsolicited and Related Unsolicited AEs | From the first dose of vaccination up to 28 days after vaccination (up to Day 29) | 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. |
| Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | From the first dose of vaccination up to 28 days after vaccination (up to Day 29) | 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. |
| Number of Participants With Any Serious Adverse Events (SAEs) up to 12 Months | From the first dose of vaccination 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. |
| Number of Participants With Any Medically-attended AEs (MAAEs) up to 12 Months | From the first dose of vaccination 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. |
| Number of Participants Who Experienced a Local Solicited Adverse Event (AE) Post Dose 1 (Day 1) | From the first dose of vaccination up to 7 days after vaccination (up to Day 8) | 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. |
| Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | From the first dose of vaccination up to 7 days after vaccination (up to Day 8) | 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). |
| Number of Participants Who Experienced a Systemic Solicited AE and Related Systemic Solicited AE Post Dose 1 (Day 1) | From the first dose of vaccination up to 7 days after vaccination (up to Day 8) | 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. |
| Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | From the first dose of vaccination up to 7 days after vaccination (up to Day 8) | 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). |
| Number of Days of Local Solicited AEs Post Dose 1 (Day 1) | From Day 1 (post-dose 1) to Day 8 | 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. |
| Number of Days of Local Solicited AEs Post Dose 2 | CV7202: From Day 29 (post-dose 2) to Day 36; Rabipur: Day 8 (post-dose 2) to Day 15 | 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. |
| Number of Days of Local Solicited AEs Post Dose 3 | Day 29 (post-dose 3) to Day 36 | 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. |
| Number of Days of Systemic Solicited AEs Post Dose 1 | From Day 1 (post-dose 1) to Day 8 | 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. |
| Number of Days of Systemic Solicited AEs Post Dose 2 | CV7202: From Day 29 (post-dose 2) to Day 36; Rabipur: Day 8 (post-dose 2) to Day 15 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Related MAAEs From 12 Months up to 24 Months | 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. |
| Number of Participants With Any Related AESIs From 12 Months up to 24 Months | 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. |
| Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Baseline (Day 1), Days 15, 43, 365, 547, and 730 | 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. |
| Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Baseline (Day 1), Days 8, 15, 29, 36, 43, 57, 91, 182, 365, 547, and 730 | 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. |
| Number of Participants With Related SAEs From 12 Months Post-vaccination up to 24 Months | 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. 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. |
Countries
Belgium, Germany
Participant flow
Recruitment details
The study was conducted at 2 investigative sites in Germany and Belgium between 12 October 2018 and 23 November 2021.
Pre-assignment details
A total 90 participants were screened, out of which 53 were enrolled and received the treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 16 |
| CV7202 5 mcg Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. | 10 |
| Rabipur® Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. | 11 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® | Total |
|---|---|---|---|---|---|
| Age, Continuous | 27.1 years STANDARD_DEVIATION 5.62 | 28.3 years STANDARD_DEVIATION 5.81 | 26.1 years STANDARD_DEVIATION 3.96 | 25.5 years STANDARD_DEVIATION 4.23 | 26.9 years STANDARD_DEVIATION 5.11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 15 Participants | 16 Participants | 10 Participants | 11 Participants | 52 Participants |
| Region of Enrollment Belgium | 16 participants | 8 participants | 10 participants | 11 participants | 45 participants |
| Region of Enrollment Germany | 0 participants | 8 participants | 0 participants | 0 participants | 8 participants |
| Sex: Female, Male Female | 9 Participants | 12 Participants | 5 Participants | 7 Participants | 33 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 5 Participants | 4 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 14 / 16 | 14 / 16 | 10 / 10 | 8 / 11 |
| serious Total, serious adverse events | 1 / 16 | 0 / 16 | 0 / 10 | 1 / 11 |
Outcome results
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.
Time frame: From Day 1 (post-dose 1) to Day 8
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CV7202 1 mcg | Number of Days of Local Solicited AEs Post Dose 1 (Day 1) | Pain | 1 Days |
| CV7202 2 mcg | Number of Days of Local Solicited AEs Post Dose 1 (Day 1) | Pain | 2 Days |
| CV7202 5 mcg | Number of Days of Local Solicited AEs Post Dose 1 (Day 1) | Pain | 3 Days |
| CV7202 5 mcg | Number of Days of Local Solicited AEs Post Dose 1 (Day 1) | Redness | 2 Days |
| Rabipur® | Number of Days of Local Solicited AEs Post Dose 1 (Day 1) | Pain | 2 Days |
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.
Time frame: CV7202: From Day 29 (post-dose 2) to Day 36; Rabipur: Day 8 (post-dose 2) to Day 15
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CV7202 1 mcg | Number of Days of Local Solicited AEs Post Dose 2 | Pain | 1 Days |
| CV7202 2 mcg | Number of Days of Local Solicited AEs Post Dose 2 | Pain | 2 Days |
| CV7202 5 mcg | Number of Days of Local Solicited AEs Post Dose 2 | Pain | 2 Days |
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.
Time frame: Day 29 (post-dose 3) to Day 36
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CV7202 1 mcg | Number of Days of Local Solicited AEs Post Dose 3 | Pain | 2 Days |
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.
Time frame: From Day 1 (post-dose 1) to Day 8
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CV7202 1 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Fatigue | 2 Days |
| CV7202 1 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Headache | 1 Days |
| CV7202 1 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Myalgia | 2 Days |
| CV7202 1 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Diarrhea | 4 Days |
| CV7202 1 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Nausea/Vomiting | 1 Days |
| CV7202 1 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Athralgia | 1 Days |
| CV7202 2 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Temperature | 1 Days |
| CV7202 2 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Headache | 2 Days |
| CV7202 2 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Fatigue | 2 Days |
| CV7202 2 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Chills | 1.5 Days |
| CV7202 2 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Myalgia | 3 Days |
| CV7202 2 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Athralgia | 1 Days |
| CV7202 2 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Nausea/Vomiting | 3 Days |
| CV7202 2 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Diarrhea | 1 Days |
| CV7202 5 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Myalgia | 2 Days |
| CV7202 5 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Diarrhea | 2 Days |
| CV7202 5 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Nausea/Vomiting | 1 Days |
| CV7202 5 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Chills | 1 Days |
| CV7202 5 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Fatigue | 2 Days |
| CV7202 5 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Temperature | 1 Days |
| CV7202 5 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Athralgia | 2 Days |
| CV7202 5 mcg | Number of Days of Systemic Solicited AEs Post Dose 1 | Headache | 2 Days |
| Rabipur® | Number of Days of Systemic Solicited AEs Post Dose 1 | Myalgia | 1 Days |
| Rabipur® | Number of Days of Systemic Solicited AEs Post Dose 1 | Headache | 1 Days |
| Rabipur® | Number of Days of Systemic Solicited AEs Post Dose 1 | Fatigue | 1 Days |
| Rabipur® | Number of Days of Systemic Solicited AEs Post Dose 1 | Nausea/Vomiting | 1 Days |
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.
Time frame: CV7202: From Day 29 (post-dose 2) to Day 36; Rabipur: Day 8 (post-dose 2) to Day 15
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CV7202 1 mcg | Number of Days of Systemic Solicited AEs Post Dose 2 | Temperature | 1 Days |
| CV7202 1 mcg | Number of Days of Systemic Solicited AEs Post Dose 2 | Headache | 1 Days |
| CV7202 1 mcg | Number of Days of Systemic Solicited AEs Post Dose 2 | Fatigue | 2 Days |
| CV7202 1 mcg | Number of Days of Systemic Solicited AEs Post Dose 2 | Chills | 1.5 Days |
| CV7202 1 mcg | Number of Days of Systemic Solicited AEs Post Dose 2 | Myalgia | 1.5 Days |
| CV7202 1 mcg | Number of Days of Systemic Solicited AEs Post Dose 2 | Arthralgia | 1 Days |
| CV7202 2 mcg | Number of Days of Systemic Solicited AEs Post Dose 2 | Diarrhea | 2 Days |
| CV7202 2 mcg | Number of Days of Systemic Solicited AEs Post Dose 2 | Headache | 2 Days |
| CV7202 2 mcg | Number of Days of Systemic Solicited AEs Post Dose 2 | Fatigue | 2 Days |
| CV7202 2 mcg | Number of Days of Systemic Solicited AEs Post Dose 2 | Arthralgia | 2 Days |
| CV7202 2 mcg | Number of Days of Systemic Solicited AEs Post Dose 2 | Chills | 1.5 Days |
| CV7202 2 mcg | Number of Days of Systemic Solicited AEs Post Dose 2 | Nausea/Vomiting | 2 Days |
| CV7202 2 mcg | Number of Days of Systemic Solicited AEs Post Dose 2 | Temperature | 1.5 Days |
| CV7202 2 mcg | Number of Days of Systemic Solicited AEs Post Dose 2 | Myalgia | 1.5 Days |
| CV7202 5 mcg | Number of Days of Systemic Solicited AEs Post Dose 2 | Fatigue | 2 Days |
| CV7202 5 mcg | Number of Days of Systemic Solicited AEs Post Dose 2 | Headache | 1.5 Days |
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.
Time frame: Day 29 (post-dose 3) to Day 36
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CV7202 1 mcg | Number of Days of Systemic Solicited AEs Post Dose 3 | Headache | 1 Days |
| CV7202 1 mcg | Number of Days of Systemic Solicited AEs Post Dose 3 | Fatigue | 2 Days |
| CV7202 1 mcg | Number of Days of Systemic Solicited AEs Post Dose 3 | Chills | 1 Days |
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.
Time frame: From the first dose of vaccination up to 7 days after vaccination (up to Day 8)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CV7202 1 mcg | Number of Participants Who Experienced a Local Solicited Adverse Event (AE) Post Dose 1 (Day 1) | 13 Participants |
| CV7202 2 mcg | Number of Participants Who Experienced a Local Solicited Adverse Event (AE) Post Dose 1 (Day 1) | 15 Participants |
| CV7202 5 mcg | Number of Participants Who Experienced a Local Solicited Adverse Event (AE) Post Dose 1 (Day 1) | 10 Participants |
| Rabipur® | Number of Participants Who Experienced a Local Solicited Adverse Event (AE) Post Dose 1 (Day 1) | 5 Participants |
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.
Time frame: From the first dose of vaccination up to 7 days after vaccination (up to Day 8)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CV7202 1 mcg | Number of Participants Who Experienced a Systemic Solicited AE and Related Systemic Solicited AE Post Dose 1 (Day 1) | Participants with Systemic Solicited AE | 11 Participants |
| CV7202 1 mcg | Number of Participants Who Experienced a Systemic Solicited AE and Related Systemic Solicited AE Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AE | 8 Participants |
| CV7202 2 mcg | Number of Participants Who Experienced a Systemic Solicited AE and Related Systemic Solicited AE Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AE | 13 Participants |
| CV7202 2 mcg | Number of Participants Who Experienced a Systemic Solicited AE and Related Systemic Solicited AE Post Dose 1 (Day 1) | Participants with Systemic Solicited AE | 13 Participants |
| CV7202 5 mcg | Number of Participants Who Experienced a Systemic Solicited AE and Related Systemic Solicited AE Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AE | 9 Participants |
| CV7202 5 mcg | Number of Participants Who Experienced a Systemic Solicited AE and Related Systemic Solicited AE Post Dose 1 (Day 1) | Participants with Systemic Solicited AE | 9 Participants |
| Rabipur® | Number of Participants Who Experienced a Systemic Solicited AE and Related Systemic Solicited AE Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AE | 5 Participants |
| Rabipur® | Number of Participants Who Experienced a Systemic Solicited AE and Related Systemic Solicited AE Post Dose 1 (Day 1) | Participants with Systemic Solicited AE | 8 Participants |
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.
Time frame: From the first dose of vaccination up to 28 days after vaccination (up to Day 29)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CV7202 1 mcg | Number of Participants Who Experienced Unsolicited and Related Unsolicited AEs | Participants with Unsolicited AEs | 10 Participants |
| CV7202 1 mcg | Number of Participants Who Experienced Unsolicited and Related Unsolicited AEs | Participants with Related Unsolicited AEs | 2 Participants |
| CV7202 2 mcg | Number of Participants Who Experienced Unsolicited and Related Unsolicited AEs | Participants with Related Unsolicited AEs | 9 Participants |
| CV7202 2 mcg | Number of Participants Who Experienced Unsolicited and Related Unsolicited AEs | Participants with Unsolicited AEs | 14 Participants |
| CV7202 5 mcg | Number of Participants Who Experienced Unsolicited and Related Unsolicited AEs | Participants with Unsolicited AEs | 9 Participants |
| CV7202 5 mcg | Number of Participants Who Experienced Unsolicited and Related Unsolicited AEs | Participants with Related Unsolicited AEs | 7 Participants |
| Rabipur® | Number of Participants Who Experienced Unsolicited and Related Unsolicited AEs | Participants with Unsolicited AEs | 6 Participants |
| Rabipur® | Number of Participants Who Experienced Unsolicited and Related Unsolicited AEs | Participants with Related Unsolicited AEs | 1 Participants |
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.
Time frame: From the first dose of vaccination up to 12 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CV7202 1 mcg | Number of Participants With Any Adverse Events of Special Interest (AESIs) and Related AESI up to 12 Month | Participants with AESIs | 0 Participants |
| CV7202 1 mcg | Number of Participants With Any Adverse Events of Special Interest (AESIs) and Related AESI up to 12 Month | Participants with related AESIs | 0 Participants |
| CV7202 2 mcg | Number of Participants With Any Adverse Events of Special Interest (AESIs) and Related AESI up to 12 Month | Participants with related AESIs | 0 Participants |
| CV7202 2 mcg | Number of Participants With Any Adverse Events of Special Interest (AESIs) and Related AESI up to 12 Month | Participants with AESIs | 0 Participants |
| CV7202 5 mcg | Number of Participants With Any Adverse Events of Special Interest (AESIs) and Related AESI up to 12 Month | Participants with AESIs | 0 Participants |
| CV7202 5 mcg | Number of Participants With Any Adverse Events of Special Interest (AESIs) and Related AESI up to 12 Month | Participants with related AESIs | 0 Participants |
| Rabipur® | Number of Participants With Any Adverse Events of Special Interest (AESIs) and Related AESI up to 12 Month | Participants with AESIs | 0 Participants |
| Rabipur® | Number of Participants With Any Adverse Events of Special Interest (AESIs) and Related AESI up to 12 Month | Participants with related AESIs | 0 Participants |
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.
Time frame: From the first dose of vaccination up to 12 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CV7202 1 mcg | Number of Participants With Any Medically-attended AEs (MAAEs) up to 12 Months | 6 Participants |
| CV7202 2 mcg | Number of Participants With Any Medically-attended AEs (MAAEs) up to 12 Months | 8 Participants |
| CV7202 5 mcg | Number of Participants With Any Medically-attended AEs (MAAEs) up to 12 Months | 3 Participants |
| Rabipur® | Number of Participants With Any Medically-attended AEs (MAAEs) up to 12 Months | 3 Participants |
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.
Time frame: From the first dose of vaccination up to 12 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CV7202 1 mcg | Number of Participants With Any Serious Adverse Events (SAEs) up to 12 Months | 1 Participants |
| CV7202 2 mcg | Number of Participants With Any Serious Adverse Events (SAEs) up to 12 Months | 0 Participants |
| CV7202 5 mcg | Number of Participants With Any Serious Adverse Events (SAEs) up to 12 Months | 0 Participants |
| Rabipur® | Number of Participants With Any Serious Adverse Events (SAEs) up to 12 Months | 1 Participants |
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).
Time frame: From the first dose of vaccination up to 7 days after vaccination (up to Day 8)
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CV7202 1 mcg | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Grade 3 (Severe) | 0 Participants |
| CV7202 1 mcg | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Grade 1 (Mild) | 13 Participants |
| CV7202 1 mcg | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Not assessed | 0 Participants |
| CV7202 1 mcg | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Grade 2 (Moderate) | 0 Participants |
| CV7202 1 mcg | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Grade 0 (No AE/Absent) | 3 Participants |
| CV7202 2 mcg | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Grade 2 (Moderate) | 1 Participants |
| CV7202 2 mcg | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Grade 3 (Severe) | 1 Participants |
| CV7202 2 mcg | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Not assessed | 0 Participants |
| CV7202 2 mcg | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Grade 1 (Mild) | 13 Participants |
| CV7202 2 mcg | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Grade 0 (No AE/Absent) | 1 Participants |
| CV7202 5 mcg | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Grade 2 (Moderate) | 5 Participants |
| CV7202 5 mcg | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Grade 0 (No AE/Absent) | 0 Participants |
| CV7202 5 mcg | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Grade 1 (Mild) | 4 Participants |
| CV7202 5 mcg | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Grade 3 (Severe) | 1 Participants |
| CV7202 5 mcg | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Not assessed | 0 Participants |
| Rabipur® | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Grade 3 (Severe) | 0 Participants |
| Rabipur® | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Grade 1 (Mild) | 5 Participants |
| Rabipur® | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Grade 0 (No AE/Absent) | 5 Participants |
| Rabipur® | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Grade 2 (Moderate) | 0 Participants |
| Rabipur® | Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) | Not assessed | 1 Participants |
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).
Time frame: From the first dose of vaccination up to 7 days after vaccination (up to Day 8)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| CV7202 1 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Grade 0 (No AE/Absent) | 5 Participants |
| CV7202 1 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Grade 1 (Mild) | 8 Participants |
| CV7202 1 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Grade 2 (Moderate) | 3 Participants |
| CV7202 1 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Grade 3 (Severe) | 0 Participants |
| CV7202 1 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Not assessed | 0 Participants |
| CV7202 1 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Grade 0 (No AE/Absent) | 8 Participants |
| CV7202 1 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Grade 1 (Mild) | 5 Participants |
| CV7202 1 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Grade 2 (Moderate) | 3 Participants |
| CV7202 1 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Grade 3 (Severe) | 0 Participants |
| CV7202 1 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Not assessed | 0 Participants |
| CV7202 2 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Grade 2 (Moderate) | 6 Participants |
| CV7202 2 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Grade 3 (Severe) | 3 Participants |
| CV7202 2 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Grade 3 (Severe) | 3 Participants |
| CV7202 2 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Not assessed | 0 Participants |
| CV7202 2 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Grade 0 (No AE/Absent) | 3 Participants |
| CV7202 2 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Grade 1 (Mild) | 4 Participants |
| CV7202 2 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Not assessed | 0 Participants |
| CV7202 2 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Grade 2 (Moderate) | 6 Participants |
| CV7202 2 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Grade 0 (No AE/Absent) | 3 Participants |
| CV7202 2 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Grade 1 (Mild) | 4 Participants |
| CV7202 5 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Grade 2 (Moderate) | 3 Participants |
| CV7202 5 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Grade 1 (Mild) | 0 Participants |
| CV7202 5 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Not assessed | 0 Participants |
| CV7202 5 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Grade 0 (No AE/Absent) | 1 Participants |
| CV7202 5 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Grade 3 (Severe) | 6 Participants |
| CV7202 5 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Grade 0 (No AE/Absent) | 1 Participants |
| CV7202 5 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Grade 3 (Severe) | 6 Participants |
| CV7202 5 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Grade 1 (Mild) | 0 Participants |
| CV7202 5 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Not assessed | 0 Participants |
| CV7202 5 mcg | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Grade 2 (Moderate) | 3 Participants |
| Rabipur® | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Not assessed | 1 Participants |
| Rabipur® | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Grade 2 (Moderate) | 3 Participants |
| Rabipur® | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Grade 0 (No AE/Absent) | 5 Participants |
| Rabipur® | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Not assessed | 1 Participants |
| Rabipur® | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Grade 1 (Mild) | 2 Participants |
| Rabipur® | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Grade 1 (Mild) | 4 Participants |
| Rabipur® | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Grade 2 (Moderate) | 4 Participants |
| Rabipur® | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Grade 3 (Severe) | 0 Participants |
| Rabipur® | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Systemic Solicited AEs | Grade 0 (No AE/Absent) | 2 Participants |
| Rabipur® | Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) | Participants with Related Systemic Solicited AEs | Grade 3 (Severe) | 0 Participants |
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.
Time frame: From the first dose of vaccination up to 28 days after vaccination (up to Day 29)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| CV7202 1 mcg | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with all unsolicited AEs | Grade 1 (Mild) | 3 Participants |
| CV7202 1 mcg | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with all unsolicited AEs | Grade 2 (Moderate) | 4 Participants |
| CV7202 1 mcg | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with all unsolicited AEs | Grade 3 (Severe) | 3 Participants |
| CV7202 1 mcg | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with related unsolicited AEs | Grade 1 (Mild) | 1 Participants |
| CV7202 1 mcg | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with related unsolicited AEs | Grade 2 (Moderate) | 1 Participants |
| CV7202 1 mcg | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with related unsolicited AEs | Grade 3 (Severe) | 0 Participants |
| CV7202 2 mcg | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with related unsolicited AEs | Grade 3 (Severe) | 2 Participants |
| CV7202 2 mcg | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with related unsolicited AEs | Grade 1 (Mild) | 4 Participants |
| CV7202 2 mcg | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with all unsolicited AEs | Grade 1 (Mild) | 3 Participants |
| CV7202 2 mcg | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with all unsolicited AEs | Grade 3 (Severe) | 2 Participants |
| CV7202 2 mcg | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with all unsolicited AEs | Grade 2 (Moderate) | 9 Participants |
| CV7202 2 mcg | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with related unsolicited AEs | Grade 2 (Moderate) | 3 Participants |
| CV7202 5 mcg | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with all unsolicited AEs | Grade 2 (Moderate) | 1 Participants |
| CV7202 5 mcg | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with all unsolicited AEs | Grade 3 (Severe) | 6 Participants |
| CV7202 5 mcg | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with related unsolicited AEs | Grade 1 (Mild) | 1 Participants |
| CV7202 5 mcg | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with related unsolicited AEs | Grade 3 (Severe) | 5 Participants |
| CV7202 5 mcg | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with related unsolicited AEs | Grade 2 (Moderate) | 1 Participants |
| CV7202 5 mcg | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with all unsolicited AEs | Grade 1 (Mild) | 2 Participants |
| Rabipur® | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with related unsolicited AEs | Grade 2 (Moderate) | 1 Participants |
| Rabipur® | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with related unsolicited AEs | Grade 3 (Severe) | 0 Participants |
| Rabipur® | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with all unsolicited AEs | Grade 2 (Moderate) | 3 Participants |
| Rabipur® | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with related unsolicited AEs | Grade 1 (Mild) | 0 Participants |
| Rabipur® | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with all unsolicited AEs | Grade 1 (Mild) | 2 Participants |
| Rabipur® | Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs | Participants with all unsolicited AEs | Grade 3 (Severe) | 1 Participants |
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.
Time frame: From 12 months up to 24 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CV7202 1 mcg | Number of Participants With Any Related AESIs From 12 Months up to 24 Months | 0 Participants |
| CV7202 2 mcg | Number of Participants With Any Related AESIs From 12 Months up to 24 Months | 0 Participants |
| CV7202 5 mcg | Number of Participants With Any Related AESIs From 12 Months up to 24 Months | 1 Participants |
| Rabipur® | Number of Participants With Any Related AESIs From 12 Months up to 24 Months | 0 Participants |
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.
Time frame: From 12 months up to 24 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CV7202 1 mcg | Number of Participants With Related MAAEs From 12 Months up to 24 Months | 0 Participants |
| CV7202 2 mcg | Number of Participants With Related MAAEs From 12 Months up to 24 Months | 0 Participants |
| CV7202 5 mcg | Number of Participants With Related MAAEs From 12 Months up to 24 Months | 0 Participants |
| Rabipur® | Number of Participants With Related MAAEs From 12 Months up to 24 Months | 0 Participants |
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.
Time frame: From 12 months up to 24 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CV7202 1 mcg | Number of Participants With Related SAEs From 12 Months Post-vaccination up to 24 Months | 0 Participants |
| CV7202 2 mcg | Number of Participants With Related SAEs From 12 Months Post-vaccination up to 24 Months | 0 Participants |
| CV7202 5 mcg | Number of Participants With Related SAEs From 12 Months Post-vaccination up to 24 Months | 0 Participants |
| Rabipur® | Number of Participants With Related SAEs From 12 Months Post-vaccination up to 24 Months | 0 Participants |
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.
Time frame: Baseline (Day 1), Days 15, 43, 365, 547, and 730
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CV7202 1 mcg | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Baseline (Day 1) | 0.0 percentage of participants |
| CV7202 1 mcg | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 15 | 0.0 percentage of participants |
| CV7202 1 mcg | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 43 | 50.0 percentage of participants |
| CV7202 1 mcg | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 365 | 12.5 percentage of participants |
| CV7202 1 mcg | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 547 | 22.2 percentage of participants |
| CV7202 1 mcg | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 730 | 22.2 percentage of participants |
| CV7202 2 mcg | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 730 | 42.9 percentage of participants |
| CV7202 2 mcg | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 365 | 14.3 percentage of participants |
| CV7202 2 mcg | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Baseline (Day 1) | 0.0 percentage of participants |
| CV7202 2 mcg | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 43 | 62.5 percentage of participants |
| CV7202 2 mcg | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 15 | 6.3 percentage of participants |
| CV7202 2 mcg | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 547 | 28.6 percentage of participants |
| CV7202 5 mcg | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 15 | 0.0 percentage of participants |
| CV7202 5 mcg | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 43 | 22.2 percentage of participants |
| CV7202 5 mcg | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 365 | 11.1 percentage of participants |
| CV7202 5 mcg | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 730 | 16.7 percentage of participants |
| CV7202 5 mcg | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 547 | 16.7 percentage of participants |
| CV7202 5 mcg | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Baseline (Day 1) | 0.0 percentage of participants |
| Rabipur® | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 547 | 90.0 percentage of participants |
| Rabipur® | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 730 | 90.0 percentage of participants |
| Rabipur® | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 15 | 100.0 percentage of participants |
| Rabipur® | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 365 | 100.0 percentage of participants |
| Rabipur® | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Baseline (Day 1) | 0.0 percentage of participants |
| Rabipur® | Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) | Day 43 | 100.0 percentage of participants |
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.
Time frame: Baseline (Day 1), Days 8, 15, 29, 36, 43, 57, 91, 182, 365, 547, and 730
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| CV7202 1 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 365 | 0.095 IU/mL | Standard Deviation 2.7511 |
| CV7202 1 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 730 | 0.128 IU/mL | Standard Deviation 3.9213 |
| CV7202 1 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 91 | 0.445 IU/mL | Standard Deviation 5.8568 |
| CV7202 1 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Baseline (Day 1) | 0.050 IU/mL | Standard Deviation 1 |
| CV7202 1 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 182 | 0.176 IU/mL | Standard Deviation 4.6498 |
| CV7202 1 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 15 | 0.069 IU/mL | Standard Deviation 1.8803 |
| CV7202 1 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 29 | 0.092 IU/mL | Standard Deviation 1.9864 |
| CV7202 1 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 8 | 0.053 IU/mL | Standard Deviation 1.2698 |
| CV7202 1 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 547 | 0.132 IU/mL | Standard Deviation 2.7428 |
| CV7202 1 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 36 | 0.231 IU/mL | Standard Deviation 3.2958 |
| CV7202 1 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 43 | 0.653 IU/mL | Standard Deviation 9.3871 |
| CV7202 1 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 57 | 0.540 IU/mL | Standard Deviation 8.2728 |
| CV7202 2 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 8 | 0.053 IU/mL | Standard Deviation 1.2179 |
| CV7202 2 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 57 | 0.502 IU/mL | Standard Deviation 7.6846 |
| CV7202 2 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 29 | 0.189 IU/mL | Standard Deviation 3.8604 |
| CV7202 2 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 182 | 0.163 IU/mL | Standard Deviation 3.6199 |
| CV7202 2 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 365 | 0.097 IU/mL | Standard Deviation 2.8842 |
| CV7202 2 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 91 | 0.275 IU/mL | Standard Deviation 6.0428 |
| CV7202 2 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Baseline (Day 1) | 0.050 IU/mL | Standard Deviation 1 |
| CV7202 2 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 43 | 0.692 IU/mL | Standard Deviation 8.364 |
| CV7202 2 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 36 | 0.433 IU/mL | Standard Deviation 5.1784 |
| CV7202 2 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 15 | 0.095 IU/mL | Standard Deviation 2.6702 |
| CV7202 2 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 730 | 0.246 IU/mL | Standard Deviation 4.0963 |
| CV7202 2 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 547 | 0.149 IU/mL | Standard Deviation 3.6318 |
| CV7202 5 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 91 | 0.105 IU/mL | Standard Deviation 2.9133 |
| CV7202 5 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Baseline (Day 1) | 0.050 IU/mL | Standard Deviation 1 |
| CV7202 5 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 8 | 0.050 IU/mL | Standard Deviation 1 |
| CV7202 5 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 15 | 0.062 IU/mL | Standard Deviation 1.5685 |
| CV7202 5 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 29 | 0.144 IU/mL | Standard Deviation 2.8064 |
| CV7202 5 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 36 | 0.136 IU/mL | Standard Deviation 3.1008 |
| CV7202 5 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 43 | 0.122 IU/mL | Standard Deviation 2.979 |
| CV7202 5 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 57 | 0.125 IU/mL | Standard Deviation 2.8786 |
| CV7202 5 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 182 | 0.074 IU/mL | Standard Deviation 2.4421 |
| CV7202 5 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 365 | 0.072 IU/mL | Standard Deviation 2.3457 |
| CV7202 5 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 547 | 0.077 IU/mL | Standard Deviation 2.9198 |
| CV7202 5 mcg | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 730 | 0.073 IU/mL | Standard Deviation 2.56 |
| Rabipur® | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 43 | 9.341 IU/mL | Standard Deviation 2.2222 |
| Rabipur® | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 36 | 8.921 IU/mL | Standard Deviation 2.4253 |
| Rabipur® | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Baseline (Day 1) | 0.050 IU/mL | Standard Deviation 1 |
| Rabipur® | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 365 | 0.816 IU/mL | Standard Deviation 2.1405 |
| Rabipur® | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 29 | 4.478 IU/mL | Standard Deviation 3.0074 |
| Rabipur® | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 15 | 7.834 IU/mL | Standard Deviation 2.7369 |
| Rabipur® | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 730 | 0.831 IU/mL | Standard Deviation 2.0624 |
| Rabipur® | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 547 | 0.879 IU/mL | Standard Deviation 1.9594 |
| Rabipur® | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 91 | 4.888 IU/mL | Standard Deviation 1.8755 |
| Rabipur® | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 57 | 7.849 IU/mL | Standard Deviation 1.8818 |
| Rabipur® | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 8 | 0.057 IU/mL | Standard Deviation 1.3394 |
| Rabipur® | Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs | Day 182 | 1.089 IU/mL | Standard Deviation 1.9244 |