Chikungunya Virus Infection
Conditions
Keywords
VLA1553, Chikungunya Virus Infection, CHIKV, Live-attenuated Chikungunya virus vaccine
Brief summary
This was a prospective, randomized, double-blinded, multicenter Phase 3 clinical study investigating three Lots of VLA1553 at the final dose. Overall 409 healthy subjects aged 18 to 45 years were randomized into the study.
Detailed description
This was a prospective, randomized, double-blinded, multicenter Phase 3 clinical study investigating three Lots of VLA1553. Overall 409 healthy subjects aged 18 to 45 years were randomized into the study, approximately136 subjects per VLA1553 Lot. Subjects were block-randomized in a 1:1:1 ratio into the three study arms to receive one of three Lots of VLA1553 as a single i.m. vaccination. The primary objective was to demonstrate Lot-to-Lot manufacturing consistency of VLA1553 28 days following the single vaccination.
Interventions
BIOLOGICALBiological Vaccine VLA1553
Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Sponsors
Valneva Austria GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18 to 45 years of age on the Day of screening 2. Able to provide informed consent 3. Generally healthy as determined by the Investigator's clinical judgement based on medical history, physical examination and screening laboratory tests 4. For women of childbearing potential: 1. practiced an adequate method of contraception during 30 days before screening 2. negative serum or urine pregnancy test at screening or vaccination, respectively 3. agreed to employ adequate birth control measures for the first three months post-vaccination.
Exclusion criteria
1. CHIKV infection in the past (self-reported), including suspected CHIKV infection; was taking medication or other treatment for unresolved symptoms attributed to a previous CHIKV infection; or had participated in a clinical study involving an investigational CHIKV vaccine 2. Acute or recent infection (and not symptom-free in the week prior to screening) 3. Tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV); 4. Received another live virus vaccine within 28 days or inactivated vaccine within 14 days prior to vaccination in this study or plans to receive a vaccine within 28 days or 14 days after vaccination, respectively 5. Abnormal findings in any required study investigations (including medical history, physical examination, and clinical laboratory) considered clinically relevant by the Investigator which pose a risk for participation in the study 6. Medical history of or currently had acute or progressive, unstable or uncontrolled clinical conditions that posed a risk for participation in the study 7. History of immune-mediated or clinically relevant arthritis / arthralgia 8. History of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there had been surgical excision or treatment more than 5 years ago that was considered to have achieved a cure, the subject could be enrolled. 9. Known or suspected defect of the immune system, such as subjects with congenital or acquired immunodeficiency, including infection with HIV, status post organ transplantation or immuno-suppressive therapy within 4 weeks prior to vaccination. 10. History of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to components of the candidate vaccine, other known contraindications) 11. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws 12. Pregnant, had plans to become pregnant during the first three months post-vaccination or lactating at the time of enrollment 13. Donation of blood, blood fractions or plasma within 30 days or received blood-derived products (e.g. plasma) within 90 days prior to vaccination in this study or planned to donate blood or use blood products until Day 180 of the study 14. Rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating 15. Known or suspected problem with alcohol or drug abuse as determined by the Investigator 16. Any condition that, in the opinion of the Investigator, could compromise the subjects well-being, could interfere with evaluation of study endpoints, or could limit the subject's ability to complete the study; 17. Committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities) 18. Participation in another clinical study involving an investigational medicinal product (IMP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IMP, or device during the course of this study 19. Member of the team conducting the study or in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the Investigator or site personnel conducting the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric Mean Titer (GMT) of CHIKV-specific Neutralizing Antibodies as Determined by Microneutralization (μPRNT) Assay in Subjects Who Tested Negative for CHIKV Antibodies at Baseline | On Day 29 after single vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects | on Day 8, 29, 85 and Month 6 | — |
| Proportion of Subjects With Seroconversion | on Day 29, Day 85 and Month 6 | — |
| Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline | on Day 8, 29, 85 and Month 6 | — |
| Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | up to Month 6 | — |
| Frequency of Solicited Injection Site | 10 days post vaccination | — |
| Frequency of Solicited Systemic Reactions | 10 days post vaccination | — |
| Severity of Solicited Injection Site | 10 days post vaccination | — |
| Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers | on Day 8, 85 and Month 6 | — |
| Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination | up to Day 29 | — |
| Frequency of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination | up to Day 29 | — |
| Severity of Any Adverse Event During the Entire Study Period | up to Month 6 | — |
| Frequency of Any Adverse Event During the Entire Study Period | up to Month 6 | — |
| Frequency of Any Serious Adverse Event (SAE) During the Entire Study Period | up to Month 6 | — |
| Severity of Any Adverse Event of Special Interest (AESI) | within 2 to 21 days post-vaccination | AESI Definition: The following cluster of symptoms suggestive of CHIKV infection with or without remissions or exacerbations received particular consideration: 1. Fever (≥38.0°C \[100.4°F\] measured orally) and 2. Acute (poly)arthralgia/arthritis most frequently in the extremities (wrists, ankles, and phalanges, often symmetric), back pain and/or neurological symptoms (e.g. confusion, optic neuritis, meningoencephalitis, or polyneuropathy) and/or cardiac symptoms (e.g. myocarditis) or One or more of the following signs and symptoms: macular to maculopapular rash (sometimes with cutaneous pruritus \[foot plant\] and edema of the face and extremities), polyadenopathies; and 3. Onset of symptoms 2 to 21 days after vaccination and 4. Duration of event ≥3 days. Ongoing AESIs are monitored for entire study period |
| Frequency of Any Adverse Event of Special Interest (AESI) | Within 2 to 21 Days Post-vaccination | — |
| Severity of Solicited Systemic Reactions | 10 days post vaccination | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VLA1553 Lot 1 Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate | 136 |
| VLA1553 Lot 2 Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate | 137 |
| VLA1553 Lot 3 Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate | 135 |
| Total | 408 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 9 | 10 |
| Overall Study | Subject would like to become pregnant | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 7 | 2 |
Baseline characteristics
| Characteristic | VLA1553 Lot 1 | VLA1553 Lot 2 | VLA1553 Lot 3 | Total |
|---|---|---|---|---|
| Age, Continuous | 33.2 years STANDARD_DEVIATION 7.03 | 33.2 years STANDARD_DEVIATION 7.78 | 33.2 years STANDARD_DEVIATION 7.43 | 33.2 years STANDARD_DEVIATION 7.4 |
| Race/Ethnicity, Customized American, Indian or Alaska Native | 4 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 5 Participants | 7 Participants | 18 Participants |
| Race/Ethnicity, Customized Black or African American | 21 Participants | 22 Participants | 19 Participants | 62 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 103 Participants | 106 Participants | 106 Participants | 315 Participants |
| Sex: Female, Male Female | 75 Participants | 76 Participants | 72 Participants | 223 Participants |
| Sex: Female, Male Male | 61 Participants | 61 Participants | 63 Participants | 185 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 136 | 0 / 137 | 0 / 135 |
| other Total, other adverse events | 90 / 136 | 91 / 137 | 92 / 135 |
| serious Total, serious adverse events | 3 / 136 | 2 / 137 | 0 / 135 |
Outcome results
Primary
Geometric Mean Titer (GMT) of CHIKV-specific Neutralizing Antibodies as Determined by Microneutralization (μPRNT) Assay in Subjects Who Tested Negative for CHIKV Antibodies at Baseline
Time frame: On Day 29 after single vaccination
Population: The Per-Protocol population used for immunogenicity analyses, is based on participants without major protocol deviations that could impact the immune response.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| VLA1553 Lot 1 | Geometric Mean Titer (GMT) of CHIKV-specific Neutralizing Antibodies as Determined by Microneutralization (μPRNT) Assay in Subjects Who Tested Negative for CHIKV Antibodies at Baseline | 2556.7 Geometric Mean Titer |
| VLA1553 Lot 2 | Geometric Mean Titer (GMT) of CHIKV-specific Neutralizing Antibodies as Determined by Microneutralization (μPRNT) Assay in Subjects Who Tested Negative for CHIKV Antibodies at Baseline | 2767.7 Geometric Mean Titer |
| VLA1553 Lot 3 | Geometric Mean Titer (GMT) of CHIKV-specific Neutralizing Antibodies as Determined by Microneutralization (μPRNT) Assay in Subjects Who Tested Negative for CHIKV Antibodies at Baseline | 2613.7 Geometric Mean Titer |
Secondary
Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Time frame: on Day 8, 29, 85 and Month 6
Population: The Per-Protocol population used for immunogenicity analyses, is based on participants who have available Day 1 and Day 29 samples and without major protocol deviations that could impact the immune response.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VLA1553 Lot 1 | Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline | Visit 2 - Day 8 | 1.58 Fold increase | Standard Deviation 1.57 |
| VLA1553 Lot 1 | Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline | Visit 3 - Day 29 | 379.56 Fold increase | Standard Deviation 319.179 |
| VLA1553 Lot 1 | Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline | Visit 4 - Day 85 | 110.92 Fold increase | Standard Deviation 79.788 |
| VLA1553 Lot 1 | Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline | Visit 5 - Day 180 | 96.20 Fold increase | Standard Deviation 79.639 |
| VLA1553 Lot 2 | Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline | Visit 5 - Day 180 | 98.57 Fold increase | Standard Deviation 71.635 |
| VLA1553 Lot 2 | Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline | Visit 2 - Day 8 | 1.37 Fold increase | Standard Deviation 1.048 |
| VLA1553 Lot 2 | Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline | Visit 4 - Day 85 | 109.81 Fold increase | Standard Deviation 76.375 |
| VLA1553 Lot 2 | Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline | Visit 3 - Day 29 | 371.37 Fold increase | Standard Deviation 294.164 |
| VLA1553 Lot 3 | Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline | Visit 5 - Day 180 | 97.24 Fold increase | Standard Deviation 83.274 |
| VLA1553 Lot 3 | Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline | Visit 3 - Day 29 | 399.91 Fold increase | Standard Deviation 523.539 |
| VLA1553 Lot 3 | Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline | Visit 4 - Day 85 | 123.20 Fold increase | Standard Deviation 100.725 |
| VLA1553 Lot 3 | Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline | Visit 2 - Day 8 | 1.32 Fold increase | Standard Deviation 1.46 |
Secondary
Frequency of Any Adverse Event During the Entire Study Period
Time frame: up to Month 6
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VLA1553 Lot 1 | Frequency of Any Adverse Event During the Entire Study Period | 98 Participants |
| VLA1553 Lot 2 | Frequency of Any Adverse Event During the Entire Study Period | 97 Participants |
| VLA1553 Lot 3 | Frequency of Any Adverse Event During the Entire Study Period | 101 Participants |
Secondary
Frequency of Any Adverse Event of Special Interest (AESI)
Time frame: Within 2 to 21 Days Post-vaccination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VLA1553 Lot 1 | Frequency of Any Adverse Event of Special Interest (AESI) | 0 Participants |
| VLA1553 Lot 2 | Frequency of Any Adverse Event of Special Interest (AESI) | 1 Participants |
| VLA1553 Lot 3 | Frequency of Any Adverse Event of Special Interest (AESI) | 0 Participants |
Secondary
Frequency of Any Serious Adverse Event (SAE) During the Entire Study Period
Time frame: up to Month 6
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VLA1553 Lot 1 | Frequency of Any Serious Adverse Event (SAE) During the Entire Study Period | 3 Participants |
| VLA1553 Lot 2 | Frequency of Any Serious Adverse Event (SAE) During the Entire Study Period | 2 Participants |
| VLA1553 Lot 3 | Frequency of Any Serious Adverse Event (SAE) During the Entire Study Period | 0 Participants |
Secondary
Frequency of Solicited Injection Site
Time frame: 10 days post vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VLA1553 Lot 1 | Frequency of Solicited Injection Site | number of subjects experiencing any solicited injection site adverse events | 23 Participants |
| VLA1553 Lot 1 | Frequency of Solicited Injection Site | Tenderness | 19 Participants |
| VLA1553 Lot 1 | Frequency of Solicited Injection Site | Pain | 7 Participants |
| VLA1553 Lot 1 | Frequency of Solicited Injection Site | Erythema/Redness | 4 Participants |
| VLA1553 Lot 1 | Frequency of Solicited Injection Site | Induration | 3 Participants |
| VLA1553 Lot 1 | Frequency of Solicited Injection Site | Swelling | 2 Participants |
| VLA1553 Lot 2 | Frequency of Solicited Injection Site | Swelling | 0 Participants |
| VLA1553 Lot 2 | Frequency of Solicited Injection Site | number of subjects experiencing any solicited injection site adverse events | 30 Participants |
| VLA1553 Lot 2 | Frequency of Solicited Injection Site | Erythema/Redness | 2 Participants |
| VLA1553 Lot 2 | Frequency of Solicited Injection Site | Induration | 1 Participants |
| VLA1553 Lot 2 | Frequency of Solicited Injection Site | Tenderness | 22 Participants |
| VLA1553 Lot 2 | Frequency of Solicited Injection Site | Pain | 10 Participants |
| VLA1553 Lot 3 | Frequency of Solicited Injection Site | Tenderness | 17 Participants |
| VLA1553 Lot 3 | Frequency of Solicited Injection Site | Pain | 9 Participants |
| VLA1553 Lot 3 | Frequency of Solicited Injection Site | Swelling | 2 Participants |
| VLA1553 Lot 3 | Frequency of Solicited Injection Site | Erythema/Redness | 5 Participants |
| VLA1553 Lot 3 | Frequency of Solicited Injection Site | number of subjects experiencing any solicited injection site adverse events | 26 Participants |
| VLA1553 Lot 3 | Frequency of Solicited Injection Site | Induration | 3 Participants |
Secondary
Frequency of Solicited Systemic Reactions
Time frame: 10 days post vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VLA1553 Lot 1 | Frequency of Solicited Systemic Reactions | Myalgia | 31 Participants |
| VLA1553 Lot 1 | Frequency of Solicited Systemic Reactions | Vomiting | 2 Participants |
| VLA1553 Lot 1 | Frequency of Solicited Systemic Reactions | Nausea | 16 Participants |
| VLA1553 Lot 1 | Frequency of Solicited Systemic Reactions | Arthralgia | 19 Participants |
| VLA1553 Lot 1 | Frequency of Solicited Systemic Reactions | number of subjects experiencing any solicited systemic adverse events | 73 Participants |
| VLA1553 Lot 1 | Frequency of Solicited Systemic Reactions | Rash | 1 Participants |
| VLA1553 Lot 1 | Frequency of Solicited Systemic Reactions | Headache | 49 Participants |
| VLA1553 Lot 1 | Frequency of Solicited Systemic Reactions | Fatigue | 53 Participants |
| VLA1553 Lot 1 | Frequency of Solicited Systemic Reactions | Fever | 16 Participants |
| VLA1553 Lot 2 | Frequency of Solicited Systemic Reactions | Arthralgia | 21 Participants |
| VLA1553 Lot 2 | Frequency of Solicited Systemic Reactions | number of subjects experiencing any solicited systemic adverse events | 78 Participants |
| VLA1553 Lot 2 | Frequency of Solicited Systemic Reactions | Fatigue | 49 Participants |
| VLA1553 Lot 2 | Frequency of Solicited Systemic Reactions | Headache | 42 Participants |
| VLA1553 Lot 2 | Frequency of Solicited Systemic Reactions | Myalgia | 35 Participants |
| VLA1553 Lot 2 | Frequency of Solicited Systemic Reactions | Nausea | 20 Participants |
| VLA1553 Lot 2 | Frequency of Solicited Systemic Reactions | Fever | 18 Participants |
| VLA1553 Lot 2 | Frequency of Solicited Systemic Reactions | Rash | 6 Participants |
| VLA1553 Lot 2 | Frequency of Solicited Systemic Reactions | Vomiting | 6 Participants |
| VLA1553 Lot 3 | Frequency of Solicited Systemic Reactions | Headache | 55 Participants |
| VLA1553 Lot 3 | Frequency of Solicited Systemic Reactions | number of subjects experiencing any solicited systemic adverse events | 82 Participants |
| VLA1553 Lot 3 | Frequency of Solicited Systemic Reactions | Fever | 18 Participants |
| VLA1553 Lot 3 | Frequency of Solicited Systemic Reactions | Fatigue | 53 Participants |
| VLA1553 Lot 3 | Frequency of Solicited Systemic Reactions | Vomiting | 2 Participants |
| VLA1553 Lot 3 | Frequency of Solicited Systemic Reactions | Arthralgia | 23 Participants |
| VLA1553 Lot 3 | Frequency of Solicited Systemic Reactions | Myalgia | 30 Participants |
| VLA1553 Lot 3 | Frequency of Solicited Systemic Reactions | Rash | 6 Participants |
| VLA1553 Lot 3 | Frequency of Solicited Systemic Reactions | Nausea | 17 Participants |
Secondary
Frequency of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination
Time frame: up to Day 29
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VLA1553 Lot 1 | Frequency of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination | 38 Participants |
| VLA1553 Lot 2 | Frequency of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination | 22 Participants |
| VLA1553 Lot 3 | Frequency of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination | 42 Participants |
Secondary
Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers
Time frame: on Day 8, 85 and Month 6
Population: The Per-Protocol population used for immunogenicity analyses, is based on participants without major protocol deviations that could impact the immune response.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VLA1553 Lot 1 | Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers | Visit 4 - Day 85 | 832.3 Geometric Mean Titer |
| VLA1553 Lot 1 | Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers | Visit 2 - Day 8 | 13.0 Geometric Mean Titer |
| VLA1553 Lot 1 | Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers | Visit 5 - Day 180 | 666.4 Geometric Mean Titer |
| VLA1553 Lot 2 | Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers | Visit 4 - Day 85 | 829.0 Geometric Mean Titer |
| VLA1553 Lot 2 | Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers | Visit 2 - Day 8 | 12.0 Geometric Mean Titer |
| VLA1553 Lot 2 | Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers | Visit 5 - Day 180 | 777.6 Geometric Mean Titer |
| VLA1553 Lot 3 | Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers | Visit 2 - Day 8 | 11.4 Geometric Mean Titer |
| VLA1553 Lot 3 | Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers | Visit 5 - Day 180 | 688.3 Geometric Mean Titer |
| VLA1553 Lot 3 | Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers | Visit 4 - Day 85 | 875.8 Geometric Mean Titer |
Secondary
Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline
Time frame: up to Month 6
Population: The Per-Protocol population used for immunogenicity analyses, is based on participants who have available Day 1 and Day 29 samples and without major protocol deviations that could impact the immune response.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VLA1553 Lot 1 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 3 - Day 29: subjects reaching 4-fold increase | 118 Participants |
| VLA1553 Lot 1 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 2 - Day 8: subjects reaching 8-fold increase | 1 Participants |
| VLA1553 Lot 1 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 2 - Day 8: subjects reaching 16-fold increase | 0 Participants |
| VLA1553 Lot 1 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 2 - Day 8: subjects reaching 64-fold increase | 0 Participants |
| VLA1553 Lot 1 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 2 - Day 8: subjects reaching 4-fold increase | 8 Participants |
| VLA1553 Lot 1 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 3 - Day 29: subjects reaching 8-fold increase | 118 Participants |
| VLA1553 Lot 1 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 3 - Day 29: subjects reaching 16-fold increase | 117 Participants |
| VLA1553 Lot 1 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 3 - Day 29: subjects reaching 64-fold increase | 116 Participants |
| VLA1553 Lot 1 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 4 - Day 85: subjects reaching 4-fold increase | 107 Participants |
| VLA1553 Lot 1 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 4 - Day 85: subjects reaching 8-fold increase | 107 Participants |
| VLA1553 Lot 1 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 4 - Day 85: subjects reaching 16-fold increase | 107 Participants |
| VLA1553 Lot 1 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 4 - Day 85: subjects reaching 64-fold increase | 75 Participants |
| VLA1553 Lot 1 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 5 - Day 180: subjects reaching 4-fold increase | 107 Participants |
| VLA1553 Lot 1 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 5 - Day 180: subjects reaching 8-fold increase | 107 Participants |
| VLA1553 Lot 1 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 5 - Day 180: subjects reaching 16-fold increase | 103 Participants |
| VLA1553 Lot 1 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 5 - Day 180: subjects reaching 64-fold increase | 69 Participants |
| VLA1553 Lot 2 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 3 - Day 29: subjects reaching 8-fold increase | 116 Participants |
| VLA1553 Lot 2 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 3 - Day 29: subjects reaching 16-fold increase | 116 Participants |
| VLA1553 Lot 2 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 3 - Day 29: subjects reaching 64-fold increase | 116 Participants |
| VLA1553 Lot 2 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 5 - Day 180: subjects reaching 8-fold increase | 108 Participants |
| VLA1553 Lot 2 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 4 - Day 85: subjects reaching 4-fold increase | 106 Participants |
| VLA1553 Lot 2 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 4 - Day 85: subjects reaching 8-fold increase | 106 Participants |
| VLA1553 Lot 2 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 5 - Day 180: subjects reaching 64-fold increase | 69 Participants |
| VLA1553 Lot 2 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 4 - Day 85: subjects reaching 16-fold increase | 106 Participants |
| VLA1553 Lot 2 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 2 - Day 8: subjects reaching 4-fold increase | 6 Participants |
| VLA1553 Lot 2 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 5 - Day 180: subjects reaching 16-fold increase | 108 Participants |
| VLA1553 Lot 2 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 2 - Day 8: subjects reaching 8-fold increase | 0 Participants |
| VLA1553 Lot 2 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 4 - Day 85: subjects reaching 64-fold increase | 71 Participants |
| VLA1553 Lot 2 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 2 - Day 8: subjects reaching 16-fold increase | 0 Participants |
| VLA1553 Lot 2 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 2 - Day 8: subjects reaching 64-fold increase | 0 Participants |
| VLA1553 Lot 2 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 3 - Day 29: subjects reaching 4-fold increase | 116 Participants |
| VLA1553 Lot 2 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 5 - Day 180: subjects reaching 4-fold increase | 108 Participants |
| VLA1553 Lot 3 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 4 - Day 85: subjects reaching 16-fold increase | 113 Participants |
| VLA1553 Lot 3 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 3 - Day 29: subjects reaching 8-fold increase | 119 Participants |
| VLA1553 Lot 3 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 5 - Day 180: subjects reaching 4-fold increase | 112 Participants |
| VLA1553 Lot 3 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 2 - Day 8: subjects reaching 16-fold increase | 0 Participants |
| VLA1553 Lot 3 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 3 - Day 29: subjects reaching 16-fold increase | 119 Participants |
| VLA1553 Lot 3 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 5 - Day 180: subjects reaching 64-fold increase | 64 Participants |
| VLA1553 Lot 3 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 2 - Day 8: subjects reaching 4-fold increase | 3 Participants |
| VLA1553 Lot 3 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 3 - Day 29: subjects reaching 64-fold increase | 116 Participants |
| VLA1553 Lot 3 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 4 - Day 85: subjects reaching 64-fold increase | 77 Participants |
| VLA1553 Lot 3 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 3 - Day 29: subjects reaching 4-fold increase | 119 Participants |
| VLA1553 Lot 3 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 4 - Day 85: subjects reaching 4-fold increase | 115 Participants |
| VLA1553 Lot 3 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 5 - Day 180: subjects reaching 8-fold increase | 110 Participants |
| VLA1553 Lot 3 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 2 - Day 8: subjects reaching 8-fold increase | 1 Participants |
| VLA1553 Lot 3 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 4 - Day 85: subjects reaching 8-fold increase | 114 Participants |
| VLA1553 Lot 3 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 2 - Day 8: subjects reaching 64-fold increase | 0 Participants |
| VLA1553 Lot 3 | Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline | Visit 5 - Day 180: subjects reaching 16-fold increase | 109 Participants |
Secondary
Proportion of Subjects With Seroconversion
Time frame: on Day 29, Day 85 and Month 6
Population: At the specified time point the number of subjects with non-missing titers is stated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VLA1553 Lot 1 | Proportion of Subjects With Seroconversion | Visit 4 - Day 85 | 107 Participants |
| VLA1553 Lot 1 | Proportion of Subjects With Seroconversion | Visit 3 - Day 29 | 118 Participants |
| VLA1553 Lot 1 | Proportion of Subjects With Seroconversion | Visit 5 - Day 180 | 107 Participants |
| VLA1553 Lot 2 | Proportion of Subjects With Seroconversion | Visit 4 - Day 85 | 106 Participants |
| VLA1553 Lot 2 | Proportion of Subjects With Seroconversion | Visit 3 - Day 29 | 116 Participants |
| VLA1553 Lot 2 | Proportion of Subjects With Seroconversion | Visit 5 - Day 180 | 108 Participants |
| VLA1553 Lot 3 | Proportion of Subjects With Seroconversion | Visit 3 - Day 29 | 119 Participants |
| VLA1553 Lot 3 | Proportion of Subjects With Seroconversion | Visit 5 - Day 180 | 112 Participants |
| VLA1553 Lot 3 | Proportion of Subjects With Seroconversion | Visit 4 - Day 85 | 115 Participants |
Secondary
Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects
Time frame: on Day 8, 29, 85 and Month 6
Population: The Per-Protocol population used for immunogenicity analyses, is based on participants who have available Day 1 and Day 29 samples and without major protocol deviations that could impact the immune response
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VLA1553 Lot 1 | Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects | Visit 2 - Day 8 | 0 Participants |
| VLA1553 Lot 1 | Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects | Visit 3 - Day 29 | 117 Participants |
| VLA1553 Lot 1 | Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects | Visit 4 - Day 85 | 106 Participants |
| VLA1553 Lot 1 | Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects | Visit 5 - Day 180 | 103 Participants |
| VLA1553 Lot 2 | Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects | Visit 5 - Day 180 | 106 Participants |
| VLA1553 Lot 2 | Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects | Visit 2 - Day 8 | 0 Participants |
| VLA1553 Lot 2 | Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects | Visit 4 - Day 85 | 104 Participants |
| VLA1553 Lot 2 | Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects | Visit 3 - Day 29 | 114 Participants |
| VLA1553 Lot 3 | Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects | Visit 5 - Day 180 | 107 Participants |
| VLA1553 Lot 3 | Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects | Visit 3 - Day 29 | 117 Participants |
| VLA1553 Lot 3 | Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects | Visit 4 - Day 85 | 111 Participants |
| VLA1553 Lot 3 | Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects | Visit 2 - Day 8 | 0 Participants |
Secondary
Severity of Any Adverse Event During the Entire Study Period
Time frame: up to Month 6
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VLA1553 Lot 1 | Severity of Any Adverse Event During the Entire Study Period | Moderate | 26 Participants |
| VLA1553 Lot 1 | Severity of Any Adverse Event During the Entire Study Period | Mild | 64 Participants |
| VLA1553 Lot 1 | Severity of Any Adverse Event During the Entire Study Period | Severe | 8 Participants |
| VLA1553 Lot 2 | Severity of Any Adverse Event During the Entire Study Period | Moderate | 27 Participants |
| VLA1553 Lot 2 | Severity of Any Adverse Event During the Entire Study Period | Mild | 66 Participants |
| VLA1553 Lot 2 | Severity of Any Adverse Event During the Entire Study Period | Severe | 4 Participants |
| VLA1553 Lot 3 | Severity of Any Adverse Event During the Entire Study Period | Mild | 61 Participants |
| VLA1553 Lot 3 | Severity of Any Adverse Event During the Entire Study Period | Severe | 4 Participants |
| VLA1553 Lot 3 | Severity of Any Adverse Event During the Entire Study Period | Moderate | 36 Participants |
Secondary
Severity of Any Adverse Event of Special Interest (AESI)
AESI Definition: The following cluster of symptoms suggestive of CHIKV infection with or without remissions or exacerbations received particular consideration: 1. Fever (≥38.0°C \[100.4°F\] measured orally) and 2. Acute (poly)arthralgia/arthritis most frequently in the extremities (wrists, ankles, and phalanges, often symmetric), back pain and/or neurological symptoms (e.g. confusion, optic neuritis, meningoencephalitis, or polyneuropathy) and/or cardiac symptoms (e.g. myocarditis) or One or more of the following signs and symptoms: macular to maculopapular rash (sometimes with cutaneous pruritus \[foot plant\] and edema of the face and extremities), polyadenopathies; and 3. Onset of symptoms 2 to 21 days after vaccination and 4. Duration of event ≥3 days. Ongoing AESIs are monitored for entire study period
Time frame: within 2 to 21 days post-vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VLA1553 Lot 1 | Severity of Any Adverse Event of Special Interest (AESI) | Moderate | 0 Participants |
| VLA1553 Lot 1 | Severity of Any Adverse Event of Special Interest (AESI) | Mild | 0 Participants |
| VLA1553 Lot 1 | Severity of Any Adverse Event of Special Interest (AESI) | Severe | 0 Participants |
| VLA1553 Lot 2 | Severity of Any Adverse Event of Special Interest (AESI) | Moderate | 0 Participants |
| VLA1553 Lot 2 | Severity of Any Adverse Event of Special Interest (AESI) | Mild | 0 Participants |
| VLA1553 Lot 2 | Severity of Any Adverse Event of Special Interest (AESI) | Severe | 1 Participants |
| VLA1553 Lot 3 | Severity of Any Adverse Event of Special Interest (AESI) | Mild | 0 Participants |
| VLA1553 Lot 3 | Severity of Any Adverse Event of Special Interest (AESI) | Severe | 0 Participants |
| VLA1553 Lot 3 | Severity of Any Adverse Event of Special Interest (AESI) | Moderate | 0 Participants |
Secondary
Severity of Solicited Injection Site
Time frame: 10 days post vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VLA1553 Lot 1 | Severity of Solicited Injection Site | Moderate | 2 Participants |
| VLA1553 Lot 1 | Severity of Solicited Injection Site | Severe | 0 Participants |
| VLA1553 Lot 1 | Severity of Solicited Injection Site | Mild | 21 Participants |
| VLA1553 Lot 2 | Severity of Solicited Injection Site | Mild | 29 Participants |
| VLA1553 Lot 2 | Severity of Solicited Injection Site | Severe | 0 Participants |
| VLA1553 Lot 2 | Severity of Solicited Injection Site | Moderate | 1 Participants |
| VLA1553 Lot 3 | Severity of Solicited Injection Site | Severe | 0 Participants |
| VLA1553 Lot 3 | Severity of Solicited Injection Site | Moderate | 0 Participants |
| VLA1553 Lot 3 | Severity of Solicited Injection Site | Mild | 26 Participants |
Secondary
Severity of Solicited Systemic Reactions
Time frame: 10 days post vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VLA1553 Lot 1 | Severity of Solicited Systemic Reactions | Moderate | 12 Participants |
| VLA1553 Lot 1 | Severity of Solicited Systemic Reactions | Mild | 56 Participants |
| VLA1553 Lot 1 | Severity of Solicited Systemic Reactions | Severe | 5 Participants |
| VLA1553 Lot 2 | Severity of Solicited Systemic Reactions | Moderate | 15 Participants |
| VLA1553 Lot 2 | Severity of Solicited Systemic Reactions | Mild | 60 Participants |
| VLA1553 Lot 2 | Severity of Solicited Systemic Reactions | Severe | 3 Participants |
| VLA1553 Lot 3 | Severity of Solicited Systemic Reactions | Mild | 61 Participants |
| VLA1553 Lot 3 | Severity of Solicited Systemic Reactions | Severe | 3 Participants |
| VLA1553 Lot 3 | Severity of Solicited Systemic Reactions | Moderate | 18 Participants |
Secondary
Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination
Time frame: up to Day 29
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VLA1553 Lot 1 | Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination | Moderate | 10 Participants |
| VLA1553 Lot 1 | Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination | Mild | 25 Participants |
| VLA1553 Lot 1 | Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination | Severe | 3 Participants |
| VLA1553 Lot 2 | Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination | Moderate | 5 Participants |
| VLA1553 Lot 2 | Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination | Mild | 17 Participants |
| VLA1553 Lot 2 | Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination | Severe | 0 Participants |
| VLA1553 Lot 3 | Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination | Mild | 32 Participants |
| VLA1553 Lot 3 | Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination | Severe | 0 Participants |
| VLA1553 Lot 3 | Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination | Moderate | 10 Participants |