SARS-CoV-2 Virus Infection
Conditions
Keywords
VLA2001, SARS-CoV-2 Virus Infection, Covid-19, inactivated-adjuvanted SARS-CoV-2 virus vaccine
Brief summary
A multicenter, 3-arm randomized dose finding study in the UK to evaluate safety, tolerability and immunogenicity of a vaccine candidate against Covid-19. 150 healthy volunteers will be enrolled and receive two shots of the vaccine candidate. All participants who receive two doses of the vaccine candidate will be invited to participate in the Booster phase.
Detailed description
The multicenter, dose finding Phase 1/2 study starts off with an open-label, dose-escalation part, thereafter, during the double-blind part of study, participants will be randomized 1:1:1 to receive the low, medium or high dose of the vaccine (VLA2001). All participants will received a total of two vaccinations intramuscularly, on day 1 and day 22. The first 5 participants in each dose group will receive VLA2001 open label, starting with the low dose of VLA2001. If no safety concerns are identified, the next 5 subjects will receive the medium dose of the vaccine. Again, if no safety issues are identified, 5 participants will be vaccinated with the high dose of the vaccine. A Data Safety and Monitoring Board (DSMB) will review accrued safety data before randomization of the remaining 135 subjects across all sites will be initiated. All study participants will be followed up for safety and immunogenicity up to approximately 6 months after receiving their second vaccination. This study was extended to investigate the tolerability, safety and immungenicity of a booster vaccination with VLA2001. All study participants, in the Booster phase, will be followed up for safety and immunogenicity up to 6 months after receiving their Booster vaccination.
Interventions
BIOLOGICALVLA2001
whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in combination with aluminium hydroxide
Sponsors
National Institute for Health Research, United Kingdom
Valneva Austria GmbH
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
1. st phase is open-label 2. nd phase is double-blind randomized (Participant, Investigator ) 3. rd phase is open-label phase
Intervention model description
1. st phase Sequential (open-label phase) 2. nd phase Parallel Assignment (double-blinded randomized phase ) 3. rd phase Parallel Assignment (open-label phase)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
- Subjects who meet ALL of the following criteria are eligible for the study: 1. Participant is 18 to 55 years of age 2. Participant who has a smart phone and is willing and able to install and use the eDiary. 3. Participant has an understanding of the study and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any study-related procedures. 4. Participant is generally healthy as determined by the Investigator 5. Participant has a Body Mass Index (BMI) of 18.0-30.0 kg/m2 6. If subject is of childbearing potential: 1. Participant has practiced an adequate method of contraception during the 30 days before screening (Visit 0). 2. Participant has a negative serum or urine pregnancy test at screening (Visit 0) or Visit 1, respectively. 3. Participant agrees to employ adequate birth control measures up to Day 106 (Visit 5). Inclusion Criteria for Booster Phase - Subjects who meet ALL of the following criteria are eligible for the Booster phase: * B1. Participant has received complete VLA2001 primary immunization (two vaccinations according to the protocol) * B2. Participant who has a smart phone and is willing and able to install and use the e-Diary. * B3. Participant has an understanding of the study and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any study-related procedures. * B4. Participant is generally healthy as determined by the Investigator's clinical judgement * B5. If a participant is of childbearing potential: 1. Participant has a negative urine pregnancy test at Visit 7 prior to booster vaccination. 2. Participant agrees to employ adequate birth control measures up to 3 months after the Booster vaccination.
Exclusion criteria
- Participants who meet ANY of the following criteria are NOT eligible for this study: 1. Clinically significant infection or other acute illness, including fever ≥ 38°C within 24 hours prior to the planned study vaccination. 2. History of laboratory-confirmed SARS-CoV-2 infection. 3. Participant had close contact to persons with confirmed SARS-CoV-2 infection within 30 days prior to screening (Visit 0). 4. Participant has participated in a clinical study involving an investigational SARS-CoV-2 vaccine. 5. Participant has an acute or recent infection not due to SARS-CoV-2 6. Participant has a history of SARS-CoV-1 or MERS infection (self-reported) 7. Participant tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). 8. Participant has received any vaccine within 30 days prior Visit 1 other than the study intervention, with the exception of the seasonal influenza vaccination. 9. Participant has abnormal findings in any required study investigations (including medical history, physical examination, and clinical laboratory) considered clinically relevant by the Investigator. 10. Participants with either medical history of or present acute or progressive, unstable or uncontrolled clinical conditions that pose a risk for participation or completion of the study, based on Investigator's clinical judgement. 11. Participants with underlying diseases with a high risk of developing severe COVID-19 symptoms if infected 12. Participant has a history of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there has been surgical excision or treatment more than 5 years ago that is considered to have achieved a cure, the subject may be enrolled. A history of hematologic malignancy is a permanent exclusion. Participants with a history of skin cancer must not be vaccinated at the previous tumour site. 13. Participant has a known or suspected defect of the immune system, such as Participants with congenital or acquired immune deficiency 14. Participant received immuno-suppressive therapy within 4 weeks prior to Visit 1 or receipt of immunosuppressive therapy is expected during the study. 15. Participant has a history of any vaccine related contraindicating event 16. Participant presents with clinical conditions representing a contraindication to intramuscular vaccination and blood draws. 17. Participant is pregnant, has plans to become pregnant up to Day 106 of the study or lactating at the time of enrolment. 18. Participant has donated blood, blood fractions or plasma within 4 weeks prior to Visit 1 or received blood-derived products (e.g. plasma) within 12 weeks prior to Visit 1 in this study or plans to donate blood or use blood products during the study. 19. Participant with clinically significant bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder) or prior history of significant bleeding or bruising following IM injections or venepuncture. 20. Participant has a rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating. 21. Participant has a known or suspected problem with alcohol or drug abuse as determined by the Investigator. 22. Participant has any condition that, in the opinion of the Investigator, may compromise the Participant's well-being, might interfere with evaluation of study endpoints, or would limit the Participant's ability to complete the study. 23. Participant is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities). 24. Participant has participated in another clinical study involving an investigational medicinal product (IMP) or device within 4 weeks prior to Visit 0 (screening) or is scheduled to participate in another clinical study involving an IMP, or device during the course of this study. 25. Participant is a member of the team conducting the study or in a dependent relationship with one of the study team members.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | within 7 days after any vaccination |
| Geometric Mean Titre (GMT) for Neutralizing Antibodies Against SARS-CoV-2 Determined by Wild-type Virus Neutralizing Assay | Day 36 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and Severity of Any AE | until Day 208 | — |
| Frequency and Severity of Any Vaccine-related AE | until Day 208 | — |
| Frequency of Any SAE | until Day 36 | All Adverse Events of Special Interest (AESIs) were treated as important medical event and were therefore be treated as SAE according to protocol. |
| Frequency of Any AESI | until Day 36 | — |
| Frequency and Severity of Any SAE | until Day 208 | — |
| Frequency and Severity of an AESI | until Day 208 | — |
| Frequency and Severy of Solicited AEs (Local and Systemic Reactions) After the Booster Vaccination | until Visit 7 plus 6 days | — |
| Frequency and Severity of Any Unsolicited AE | until Visit 9 | — |
| Frequency and Severity of Any AESI | until Visit 10 | — |
| Immune Response as Measured by Neutralizing Antibody Titres Against SARS-CoV-2 | until Day 208 | — |
| Proportion of Participants With Seroconversion in Terms of Neutralizing Antibodies | until Day 208 | — |
| Fold Increase of SARS-CoV-2 Neutralizing Antibody Titres Compared With Baseline | until Day 208 | — |
| Frequency of Any Unsolicited AE | until Day 36 | — |
| Proportion of Participants With Seroconversion in Terms of IgG Antibodies Against SARS-CoV-2, as Determined by ELISA in Participants Negative for SARS-CoV-2 at Screening | until Day 208 | — |
| Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose With Regards to Neutralizing Antibodies | until Visit 8 | — |
| Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose With Regards to Neutralizing Antibodies | until Visit 9 | — |
| Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose With Regards to Neutralizing Antibodies | until Visit 8 | — |
| Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose With Regards to Neutralizing Antibodies | until Visit 9 | — |
| Geometric Mean Titres (GMT) Measured as Neutralizing Antibody Titres Against SARSCoV-2 | until Visit 9 | — |
| Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose With Regards to S-protein Binding Antibodies (ELISA) | until Visit 8 | — |
| Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose With Regards to S-protein Binding Antibodies (ELISA) | until Visit 9 | — |
| Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose in Regards to S-protein Binding Antibodies (ELISA) | until Visit 8 | — |
| Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose in Regards to S-protein Binding Antibodies (ELISA) | until Visit 9 | — |
| Geometric Mean Titres (GMT) Measured as IgG Antibodies Against SARS-CoV-2 (ELISA | until Visit 9 | — |
| GMTs for IgG Antibodies Against SARS-CoV-2 Determined by ELISA | until Day 208 | — |
| Frequency of Any Vaccine-related AE | until Day 36 | — |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Dose: VLA2001 VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide | 51 |
| Medium Dose: VLA2001 VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide | 51 |
| High Dose: VLA2001 VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide | 51 |
| Total | 153 |
Baseline characteristics
| Characteristic | Low Dose: VLA2001 | Medium Dose: VLA2001 | High Dose: VLA2001 | Total |
|---|---|---|---|---|
| Age, Continuous | 33.7 years STANDARD_DEVIATION 8.89 | 35.5 years STANDARD_DEVIATION 9.53 | 31.3 years STANDARD_DEVIATION 8.52 | 33.5 years STANDARD_DEVIATION 9.1 |
| Race/Ethnicity, Customized Asian | 1 count of participants | 0 count of participants | 0 count of participants | 1 count of participants |
| Race/Ethnicity, Customized Black | 0 count of participants | 0 count of participants | 0 count of participants | 0 count of participants |
| Race/Ethnicity, Customized Latin | 1 count of participants | 0 count of participants | 0 count of participants | 1 count of participants |
| Race/Ethnicity, Customized Latin American | 2 count of participants | 0 count of participants | 0 count of participants | 2 count of participants |
| Race/Ethnicity, Customized Latino | 1 count of participants | 0 count of participants | 0 count of participants | 1 count of participants |
| Race/Ethnicity, Customized Mixed | 0 count of participants | 0 count of participants | 4 count of participants | 4 count of participants |
| Race/Ethnicity, Customized White | 46 count of participants | 51 count of participants | 46 count of participants | 143 count of participants |
| Race/Ethnicity, Customized White European | 0 count of participants | 0 count of participants | 1 count of participants | 1 count of participants |
| Sex: Female, Male Female | 24 Participants | 17 Participants | 29 Participants | 70 Participants |
| Sex: Female, Male Male | 27 Participants | 34 Participants | 22 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 8 / 51 | 6 / 51 | 12 / 51 |
| serious Total, serious adverse events | 0 / 51 | 1 / 51 | 0 / 51 |
Outcome results
Primary
Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series
Time frame: within 7 days after any vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Fatigue | 23 events |
| Low Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Injection site swelling | 1 events |
| Low Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Nausea/Vomiting | 5 events |
| Low Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Headache | 28 events |
| Low Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Subjects with at least one Solicited Systemic Reactions | 37 events |
| Low Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Subjects with at least one Solicited Injection Site Reaction | 35 events |
| Low Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Injection site pain | 19 events |
| Low Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Injection site tenderness | 32 events |
| Low Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Muscle pain | 18 events |
| Low Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Injection site itching | 3 events |
| Low Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Fever/Body temperature | 2 events |
| Medium Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Subjects with at least one Solicited Systemic Reactions | 32 events |
| Medium Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Subjects with at least one Solicited Injection Site Reaction | 31 events |
| Medium Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Injection site tenderness | 23 events |
| Medium Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Injection site pain | 21 events |
| Medium Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Injection site itching | 3 events |
| Medium Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Injection site swelling | 0 events |
| Medium Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Headache | 17 events |
| Medium Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Fatigue | 15 events |
| Medium Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Muscle pain | 15 events |
| Medium Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Nausea/Vomiting | 7 events |
| Medium Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Fever/Body temperature | 0 events |
| High Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Nausea/Vomiting | 6 events |
| High Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Fatigue | 22 events |
| High Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Injection site pain | 24 events |
| High Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Subjects with at least one Solicited Injection Site Reaction | 36 events |
| High Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Muscle pain | 17 events |
| High Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Injection site tenderness | 34 events |
| High Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Subjects with at least one Solicited Systemic Reactions | 37 events |
| High Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Injection site swelling | 1 events |
| High Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Fever/Body temperature | 0 events |
| High Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Headache | 26 events |
| High Dose: VLA2001 | Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series | Injection site itching | 2 events |
Primary
Geometric Mean Titre (GMT) for Neutralizing Antibodies Against SARS-CoV-2 Determined by Wild-type Virus Neutralizing Assay
Time frame: Day 36
Population: Overall Number of Participants analyzed according to Per-Protocol Analysis Set. The Per-Protocol Analysis Set includes all participants who have no major protocol deviations. Participants who received an already licensed COVID-19 vaccine outside of the study or participants who received less than 2 vaccinations will be excluded.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Low Dose: VLA2001 | Geometric Mean Titre (GMT) for Neutralizing Antibodies Against SARS-CoV-2 Determined by Wild-type Virus Neutralizing Assay | 161.1 Geometric Mean Titer |
| Medium Dose: VLA2001 | Geometric Mean Titre (GMT) for Neutralizing Antibodies Against SARS-CoV-2 Determined by Wild-type Virus Neutralizing Assay | 222.3 Geometric Mean Titer |
| High Dose: VLA2001 | Geometric Mean Titre (GMT) for Neutralizing Antibodies Against SARS-CoV-2 Determined by Wild-type Virus Neutralizing Assay | 530.4 Geometric Mean Titer |
Secondary
Fold Increase of SARS-CoV-2 Neutralizing Antibody Titres Compared With Baseline
Time frame: until Day 208
Secondary
Frequency and Severity of an AESI
Time frame: until Day 208
Secondary
Frequency and Severity of Any AE
Time frame: until Day 208
Secondary
Frequency and Severity of Any AESI
Time frame: until Visit 10
Secondary
Frequency and Severity of Any SAE
Time frame: until Visit 10
Secondary
Frequency and Severity of Any SAE
Time frame: until Day 208
Secondary
Frequency and Severity of Any Unsolicited AE
Time frame: until Visit 9
Secondary
Frequency and Severity of Any Vaccine-related AE
Time frame: until Visit 9
Secondary
Frequency and Severity of Any Vaccine-related AE
Time frame: until Day 208
Secondary
Frequency and Severy of Solicited AEs (Local and Systemic Reactions) After the Booster Vaccination
Time frame: until Visit 7 plus 6 days
Secondary
Frequency of Any AESI
Time frame: until Day 36
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Dose: VLA2001 | Frequency of Any AESI | 0 events |
| Medium Dose: VLA2001 | Frequency of Any AESI | 1 events |
| High Dose: VLA2001 | Frequency of Any AESI | 0 events |
Secondary
Frequency of Any SAE
All Adverse Events of Special Interest (AESIs) were treated as important medical event and were therefore be treated as SAE according to protocol.
Time frame: until Day 36
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Dose: VLA2001 | Frequency of Any SAE | 0 events |
| Medium Dose: VLA2001 | Frequency of Any SAE | 1 events |
| High Dose: VLA2001 | Frequency of Any SAE | 0 events |
Secondary
Frequency of Any Unsolicited AE
Time frame: until Day 36
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Diarrhoea | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Urinary tract infections | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Subjects with at least one unsolicited AE | 22 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Constipation | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | COVID-19 | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Blood and lymphatic system disorders | 4 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Reproductive system and breast disorders | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Aphthous ulcer | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Neutropenia | 2 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Investigations | 10 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Gastrointestinal disorders | 3 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Lymphopenia | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Eye disorders | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Ligament sprain | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Thrombocytopenia | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Haematuria | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Chillblains | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Eosinophilia | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Red blood cell sedimentation rate increased | 5 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Vaccination complications | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Leukopenia | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Anxiety | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Injury, poisoning and procedural complications | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Microcytic anaemia | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Renal and urinary disorders | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Sinus congestion | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Neutrophilia | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Gastroenteritis | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Rhinorrhoea | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Nervous system disorders | 3 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Increased appetite | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Cough | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Headache | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Lymphocyte count decreased | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Oropharyngeal pain | 3 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Dizziness | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Haemoglobin decreased | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Respiratory, thoracic and mediastinal disorders | 3 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Paraesthesia | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Dehydration | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Red blood cells urine | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Psychiatric disorders | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Metabolism and nutrition disorders | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | White blood cell count decreased | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Tooth infections | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Pain in extremity | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Alanine aminotransferase increased | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Rash erythematous | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Musculoskeletal stiffness | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Blood sodium decreased | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Asthenopia | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Limb discomfort | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | C-reactive protein increased | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Vulvovaginal candidiasis | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Arthritis | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Neutrophil count decreased | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Infections and infestations | 4 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Musculoskeletal and connective tissue disorders | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Prothrombin time prolonged | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Vaginal haemorrhage | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Peripheral swelling | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Red blood cell count decreased | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Presyncope | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Pain | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | White blood cell count increased | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Blood bilirubin increased | 2 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Influenza like illness | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Epididymitis | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Dysmenorrhoea | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | General disorders and administration site conditions | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Onychomycosis | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Aspartate aminotransferase increased | 2 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Gingival discomfort | 1 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Paronychia | 0 events |
| Low Dose: VLA2001 | Frequency of Any Unsolicited AE | Skin and subcutaneous tissue disorders | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Eye disorders | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Blood bilirubin increased | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Infections and infestations | 5 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | COVID-19 | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Gastroenteritis | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Tooth infections | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Vulvovaginal candidiasis | 2 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Presyncope | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Aspartate aminotransferase increased | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Subjects with at least one unsolicited AE | 17 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Investigations | 8 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Red blood cell sedimentation rate increased | 4 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Haemoglobin decreased | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Lymphocyte count decreased | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Red blood cells urine | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | White blood cell count decreased | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Alanine aminotransferase increased | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Blood sodium decreased | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | C-reactive protein increased | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Neutrophil count decreased | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Prothrombin time prolonged | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Red blood cell count decreased | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | White blood cell count increased | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Epididymitis | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Onychomycosis | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Paronychia | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Urinary tract infections | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Diarrhoea | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Blood and lymphatic system disorders | 2 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Neutropenia | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Lymphopenia | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Thrombocytopenia | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Eosinophilia | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Leukopenia | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Microcytic anaemia | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Neutrophilia | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Nervous system disorders | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Headache | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Dizziness | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Paraesthesia | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Respiratory, thoracic and mediastinal disorders | 3 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Oropharyngeal pain | 3 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Cough | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Rhinorrhoea | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Sinus congestion | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Injury, poisoning and procedural complications | 2 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Vaccination complications | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Chillblains | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Ligament sprain | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Gastrointestinal disorders | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Aphthous ulcer | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Constipation | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Gingival discomfort | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | General disorders and administration site conditions | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Influenza like illness | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Pain | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Peripheral swelling | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Musculoskeletal and connective tissue disorders | 2 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Arthritis | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Limb discomfort | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Musculoskeletal stiffness | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Pain in extremity | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Metabolism and nutrition disorders | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Dehydration | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Increased appetite | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Renal and urinary disorders | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Haematuria | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Reproductive system and breast disorders | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Dysmenorrhoea | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Asthenopia | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Psychiatric disorders | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Anxiety | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Skin and subcutaneous tissue disorders | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Rash erythematous | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Unsolicited AE | Vaginal haemorrhage | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Constipation | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Paronychia | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Diarrhoea | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Onychomycosis | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Blood bilirubin increased | 2 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Gingival discomfort | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Epididymitis | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Dysmenorrhoea | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | General disorders and administration site conditions | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Vulvovaginal candidiasis | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Paraesthesia | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Influenza like illness | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Red blood cell count decreased | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Tooth infections | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Pain | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Prothrombin time prolonged | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Rash erythematous | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Peripheral swelling | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Neutrophil count decreased | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Asthenopia | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Musculoskeletal and connective tissue disorders | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | C-reactive protein increased | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Gastroenteritis | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Arthritis | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Blood sodium decreased | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Eye disorders | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Limb discomfort | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Alanine aminotransferase increased | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Psychiatric disorders | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Musculoskeletal stiffness | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | White blood cell count decreased | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | COVID-19 | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Pain in extremity | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Red blood cells urine | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Aspartate aminotransferase increased | 2 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Metabolism and nutrition disorders | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Lymphocyte count decreased | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Anxiety | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Dehydration | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Haemoglobin decreased | 2 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Dizziness | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Infections and infestations | 2 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Respiratory, thoracic and mediastinal disorders | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Headache | 3 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Increased appetite | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Oropharyngeal pain | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Nervous system disorders | 3 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Red blood cell sedimentation rate increased | 5 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Cough | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Neutrophilia | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Vaginal haemorrhage | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Rhinorrhoea | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Microcytic anaemia | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Renal and urinary disorders | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Sinus congestion | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Leukopenia | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Investigations | 8 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Injury, poisoning and procedural complications | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Eosinophilia | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Skin and subcutaneous tissue disorders | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Vaccination complications | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Thrombocytopenia | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Haematuria | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Chillblains | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Lymphopenia | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Subjects with at least one unsolicited AE | 21 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Ligament sprain | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Neutropenia | 3 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | White blood cell count increased | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Gastrointestinal disorders | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Blood and lymphatic system disorders | 4 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Reproductive system and breast disorders | 1 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Aphthous ulcer | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Urinary tract infections | 0 events |
| High Dose: VLA2001 | Frequency of Any Unsolicited AE | Presyncope | 0 events |
Secondary
Frequency of Any Vaccine-related AE
Time frame: until Day 36
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Gastroenteritis | 0 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Limb discomfort | 0 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Thromocytopenia | 0 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Infections and infestations | 0 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Subjects with at least one treatment related unsolicited AE until Day 36 | 12 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Nervous system disorders | 2 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Blood bilirubin increased | 1 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Musculoskeletal and connective tissue disorders | 1 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Dizziness | 1 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Rash erythematous | 0 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Oropharyngeal pain | 2 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Headache | 0 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Pain | 1 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Respiratory, thoracic and mediastinial disorders | 2 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Paraesthesia | 1 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Lymphocyte count decreased | 0 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Red blood cell sedimentation rate increased | 5 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | General disorders and administration site conditions | 1 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | White blood cell count decreased | 0 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Investigations | 6 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Diarrhoea | 1 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Blood and lymphatic system disorders | 2 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Skin and subcutaneous tissue disorders | 0 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Gastrointestinal disorders | 1 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Neutropenia | 1 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Alanine aminotransferase increased | 0 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Musculoskeletal stiffness | 1 events |
| Low Dose: VLA2001 | Frequency of Any Vaccine-related AE | Eosinophilia | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Musculoskeletal and connective tissue disorders | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Subjects with at least one treatment related unsolicited AE until Day 36 | 7 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Investigations | 5 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Red blood cell sedimentation rate increased | 3 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Alanine aminotransferase increased | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Blood bilirubin increased | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Lymphocyte count decreased | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | White blood cell count decreased | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Blood and lymphatic system disorders | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Neutropenia | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Eosinophilia | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Thromocytopenia | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Nervous system disorders | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Dizziness | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Headache | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Paraesthesia | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Respiratory, thoracic and mediastinial disorders | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Oropharyngeal pain | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Limb discomfort | 1 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Musculoskeletal stiffness | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Gastrointestinal disorders | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Diarrhoea | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | General disorders and administration site conditions | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Pain | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Infections and infestations | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Gastroenteritis | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Skin and subcutaneous tissue disorders | 0 events |
| Medium Dose: VLA2001 | Frequency of Any Vaccine-related AE | Rash erythematous | 0 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Limb discomfort | 0 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Neutropenia | 1 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Subjects with at least one treatment related unsolicited AE until Day 36 | 8 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Musculoskeletal stiffness | 0 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Blood and lymphatic system disorders | 2 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Gastroenteritis | 1 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Gastrointestinal disorders | 0 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | White blood cell count decreased | 0 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Red blood cell sedimentation rate increased | 3 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Diarrhoea | 0 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Lymphocyte count decreased | 0 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Rash erythematous | 1 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | General disorders and administration site conditions | 0 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Blood bilirubin increased | 0 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Skin and subcutaneous tissue disorders | 1 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Pain | 0 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Paraesthesia | 0 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Headache | 1 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Alanine aminotransferase increased | 1 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Respiratory, thoracic and mediastinial disorders | 0 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Dizziness | 0 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Investigations | 4 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Oropharyngeal pain | 0 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Nervous system disorders | 1 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Thromocytopenia | 1 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Musculoskeletal and connective tissue disorders | 0 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Eosinophilia | 0 events |
| High Dose: VLA2001 | Frequency of Any Vaccine-related AE | Infections and infestations | 1 events |
Secondary
Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose With Regards to Neutralizing Antibodies
Time frame: until Visit 8
Secondary
Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose With Regards to S-protein Binding Antibodies (ELISA)
Time frame: until Visit 8
Secondary
Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose With Regards to Neutralizing Antibodies
Time frame: until Visit 9
Secondary
Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose With Regards to S-protein Binding Antibodies (ELISA)
Time frame: until Visit 9
Secondary
Geometric Mean Titres (GMT) Measured as IgG Antibodies Against SARS-CoV-2 (ELISA
Time frame: until Visit 9
Secondary
Geometric Mean Titres (GMT) Measured as Neutralizing Antibody Titres Against SARSCoV-2
Time frame: until Visit 9
Secondary
GMTs for IgG Antibodies Against SARS-CoV-2 Determined by ELISA
Time frame: until Day 208
Secondary
Immune Response as Measured by Neutralizing Antibody Titres Against SARS-CoV-2
Time frame: until Day 208
Secondary
Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose in Regards to S-protein Binding Antibodies (ELISA)
Time frame: until Visit 8
Secondary
Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose With Regards to Neutralizing Antibodies
Time frame: until Visit 8
Secondary
Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose in Regards to S-protein Binding Antibodies (ELISA)
Time frame: until Visit 9
Secondary
Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose With Regards to Neutralizing Antibodies
Time frame: until Visit 9
Secondary
Proportion of Participants With Seroconversion in Terms of IgG Antibodies Against SARS-CoV-2, as Determined by ELISA in Participants Negative for SARS-CoV-2 at Screening
Time frame: until Day 208
Secondary
Proportion of Participants With Seroconversion in Terms of Neutralizing Antibodies
Time frame: until Day 208