Lyme Borreliosis
Conditions
Keywords
VLA15, Lyme Borreliosis, Vaccine
Brief summary
In the Main Study Phase a total of 246 subjects were randomized 2:2:1 into three treatment groups to receive either VLA15 with Alum (lower or higher dose) or Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1, Day 57 and Day 180. In the Booster Phase subjects from the higher dose group who completed their primary immunization schedule according to protocol will be randomized 2:1 to receive an additional higher dose VLA15 vaccination or Placebo at Month 18. Study duration in the Main Study Phase per subject is a maximum of 20 months. Overall study Duration is estimated to be 22 months. Study duration per subject in the Booster Phase is a maximum of approximately 13 months. Study duration per subject in the Main Study Phase and Booster Phase together is estimated to be a maximum of approximately 33 months. Overall study duration (i.e., First-Subject-In to Last-Subject Out/ end of Booster Phase) is estimated to be approximately 37 months.
Detailed description
This is a randomized, observer-blind (subject, Sponsor and investigator/site staff involved in Clinical Evaluation of subjects are blinded), Placebo controlled, multicenter Phase 2 study. In Main Study Phase a total of 246 healthy subjects,aged 18 to 65 years, were randomized 2:2:1 to receive either VLA15 with Alum (lower or higher doser Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1 (Month 0), Day 57 (Month 2) and Day 180 (Month 6). Subjects from the higher dose group who completed their primary immunization schedule according to protocol, will be randomized 2:1 to receive an additional injection of the higher dose VLA15 with Alum or Placebo in a Booster Phase. The additional vaccination is administered as intramuscular injection approximately 18 months after the first immunization.
Interventions
BIOLOGICALVLA15
a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate
BIOLOGICALPlacebo
PBS (Phosphate Buffered Saline)
Sponsors
Valneva Austria GmbH
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
- Main Study Phase: * Subject is aged 18 to 65 years at the day of screening * Subject is of good general health, including subjects with pharmacologically controlled chronic conditions; * Subject has an understanding of the study and its procedures, agrees to its provisions,and gives written informed consent prior to any study-related procedures; * If subject is of childbearing potential: * Subject has a negative serum pregnancy test at screening; * Subject agrees to employ adequate birth control measures for the duration of the study. Inclusion Criteria - Booster Phase: 1. Randomization into higher dose group in the Main Study Phase 2. No relevant protocol deviation in the Main Study Phase, i.e., included in the Per-Protocol population for the Day 208 interim analysis of the Main Study; 3. Subject is of good general health, including subjects with pharmacologically controlled chronic conditions; 4. Subject has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures; 5. If subject is of childbearing potential: 1. Subject has a negative Urine pregnancy test before booster vaccination; 2. Subject agrees to employ adequate birth control measures for the duration of the study
Exclusion criteria
- Main Study Phase: * Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB as suspected or diagnosed by a physician, or received treatment for LB within the last 3 months prior to screening; * Subject received previous vaccination against LB.; * Subject had a tick bite within 4 weeks prior to vaccination visit; * Subject has a medical history of or currently has a clinically relevant disease (e.g. cardiovascular, respiratory, neurologic, psychiatric conditions) which poses a risk for participation in the study, based on investigators judgement, such as individuals with poorly controlled or unstable disease, ongoing suspected or active inflammation, or poor compliance with pharmacologic treatment. Subjects with pharmacologically controlled conditions like osteoarthritis, depression, or asthma are eligible; * Subject has a medical history of or currently has a neuroinflammatory or autoimmune disease, including Guillain Barré Syndrome; * Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the three weeks prior to each study vaccination, contraindicating I.M. vaccination as judged by the investigator; * Subject has received an active or passive immunization within 28 days before or after any vaccination; except for influenza (seasonal or pandemic) vaccines which may be administered outside a 7-days interval before or after any trial vaccination; * Subject has received any other non-registered medicinal product in another clinical Trial within 28 days prior to VLA15 vaccination and throughout the entire study period or has received a registered medicinal product in another clinical Trial within 28 days prior to VLA15 vaccination and up to Day 208; * Subject has a known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired immunodeficiency, including infection with human immunodeficiency virus (HIV), Status post organ transplantation or immuno-suppressive therapy within 30 days prior to first vaccination. Immuno-suppressive therapy is defined as administration of chronic (longer than 14 days) prednisone or equivalent \>=0.05 mg/kg/day. Topical and inhaled steroids are allowed; * Subject has a history of anaphylaxis or severe allergic reactions or a known hypersensitivity or allergic reactions to one of the components of the vaccine; Subject had any malignancy in the past 5 years. If treatment for cancer was successfully completed more than 5 years ago and the malignancy is considered to be cured, the subject may be enrolled; * Subject had acute febrile infections within 10 days prior to first vaccination; * Subject is pregnant (positive serum pregnancy test at screening), has plans to become pregnant during the course of the study or is lactating at the time of enrollment. Women of childbearing potential that are unwilling or unable to employ an adequate birth Control measure for the duration of the study. * Subject has donated blood or blood-derived products (e.g. plasma) within 30 days or received blood or blood-derived products (e.g. plasma) within 90 days prior to first vaccination in this study or plans to donate or use blood or blood products during the course of the study; * Subject has any condition that, in the opinion of the investigator, may compromise the subject's well-being, might interfere with evaluation of study endpoints, or would Limit the subject's ability to complete the study; * Subject is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities); * Subject is in a dependent relationship with the sponsor, an investigator or other study team member, or the study center. Dependent relationships include close relatives and household members (i.e. children, partner/spouse, siblings, parents) as well as employees of the investigator or study center personnel.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GMTs for IgG Against Each OspA Serotype | Day 208 (Month 7) | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) against each Outer Surface Protein A (OspA) serotype ST1 to ST6, determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 208 (Month 7) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18) | Seroconversion Rate (SCR) for each Outer Surface Protein A (OspA) serotype specific IgG ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18). Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): greater than or equal to (\>=) 4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. Percentages are based on the number of participants with non-missing observations. |
| GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | Day 1 (baseline from where comparison was done), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18) | Geometric Mean Fold Rise (GMFR) as compared to baseline for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18). |
| GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18) | GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 18 - 49 years. |
| GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18) | GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 50 - 65 years. |
| SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18) | SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 18 - 49 years. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): \>=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. |
| SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18) | SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 50 - 65 years. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): \>=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. |
| GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | Day 1 (baseline), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18) | GMFR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 18 - 49 years. |
| GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | Day 1 (baseline), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18) | GMFR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 50 - 65 years. |
| Percentage of Participants With Serious Adverse Events (SAEs) During the Main Study Phase | From Day 1 of vaccination up to Day 545 (Month 18) | SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Two-sided 95% confidence intervals were calculated according to Altman method. |
| Percentage of Participants With Related SAEs During the Main Study Phase | From Day 1 of vaccination up to Day 545 (Month 18) | SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method. |
| Percentage of Participants Adverse Event of Special Interest (AESIs) During the Main Study Phase | From Day 1 of vaccination up to Day 545 (Month 18) | AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Two-sided 95% confidence intervals were calculated according to Altman method. |
| Percentage of Participants With Related AESIs During the Main Study Phase | From Day 1 of vaccination up to Day 545 (Month 18) | AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method. |
| Percentage of Participants With Unsolicited AEs During the Main Study Phase | From Day 1 of vaccination up to Day 545 (Month 18) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Two-sided 95% confidence intervals were calculated according to Altman method. |
| Percentage of Participants With Related Unsolicited AEs During the Main Study Phase | From Day 1 of vaccination up to Day 545 (Month 18) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method. |
| Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Up to 7 days after Vaccination 1, 2 and 3; Up to 7 days after any vaccination | Solicited local AEs included pain, tenderness, induration (hardening), swelling and erythema (redness). Solicited systemic AEs included headache, myalgia (muscle pain), arthralgia (joint pain), fever (oral body temperature), flu-like symptoms, nausea, vomiting and fatigue. Two-sided 95% confidence intervals were calculated according to Altman method. |
| Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | From Day 1 of vaccination up to Day 545 (Month 18) | Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs during main study phase stratified by age group 18-49 years and 50-65 years were reported. SAE: any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. AESI: any AEs of scientific/medical concern specific to study vaccine. Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AE: any untoward medical occurrence in participant associated with use of study vaccine, whether or not related to study vaccine, reported in addition to solicited and any solicited symptom with onset outside specified period of follow-up. Two-sided 95% confidence intervals were calculated according to Altman method. |
| GMTs for IgG Against Each OspA Serotype During the Main Study Phase | At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 365 (Month 12) and Day 545 (Month 18) | GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 365 (Month 12) and 545 (Month 18). |
| SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30 | SCR for each OspA serotype specific IgG ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24, and Month 30. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): greater than or equal to (\>=) 4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. Percentages are based on the number of participants with non-missing observations. The outcome measure was planned to be analyzed for Booster PP population from Day 29 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase. |
| GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | Day 1 (baseline from where comparison was done), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30 | GMFR as compared to baseline for IgG against each Osp serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 were reported in this outcome measure. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase. |
| GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | Day 208 (from where comparison was done), Month 19, Month 24 and Month 30 | GMFR as compared to Day 208 for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Month 19, Month 24 and Month 30. The outcome measure was planned to be analyzed for Booster PP population from Day 208 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase. |
| GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | Month 18 (from where comparison was done), Month 19, Month 24 and Month 30 | GMFR as compared to Month 18 (pre-booster) for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Month 19, Month 24 and Month 30. The outcome measure was planned to be analyzed for Booster PP population. |
| GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30 | GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 stratified by age group: 18 - 49 years. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase. |
| GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30 | GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 stratified by age group: 50 - 65 years. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase. |
| SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30 | SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 stratified by age group: 18 - 49 years was presented in this outcome measure. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): \>=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. The outcome measure was planned to be analyzed for Booster PP population from Day 29 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase. |
| SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30 | SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24, and Month 30 stratified by age group: 50 - 65 years. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): \>=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. The outcome measure was planned to be analyzed for Booster PP population from Day 29 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase. |
| Percentage of Participants With SAEs During the Entire Booster Phase | From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months) | SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Two-sided 95% confidence intervals were calculated according to Altman method. |
| Percentage of Participants With Related SAEs During the Entire Booster Phase | From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months) | SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method. |
| Percentage of Participants With Adverse Event of Special Interest (AESIs) During the Entire Booster Phase | From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months) | AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Two-sided 95% confidence intervals were calculated according to Altman method. |
| Percentage of Participants With Related AESIs During the Entire Booster Phase | From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months) | AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method. |
| Percentage of Participants With Unsolicited AEs During the Booster Phase up to Month 19 | From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month) | An unsolicited AE includes any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Two-sided 95% confidence intervals were calculated according to Altman method. |
| Percentage of Participants With Related Unsolicited AEs During the Booster Phase up to Month 19 | From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month) | An unsolicited AE included any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method. |
| Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Vaccination | Within 7 days after booster vaccination | Solicited local AEs included pain, tenderness, induration (hardening), swelling and erythema (redness). Solicited systemic AEs included headache, myalgia (muscle pain), arthralgia (joint pain), fever (oral body temperature), flu-like symptoms, nausea, vomiting and fatigue. Two-sided 95% confidence intervals were calculated according to Altman method. |
| Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase | SAEs and AESIs: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months); AEs: From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month) | Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs during booster phase stratified by age group 18-49 years and 50-65 years were reported. SAE: any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. AESI: any AEs of scientific/medical concern specific to study vaccine; Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AE: any untoward medical occurrence in participant associated with use of study vaccine, whether or not related to study vaccine, reported in addition to solicited and any solicited symptom with onset outside specified period of follow-up. |
| GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30 | GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24, and Month 30. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VLA15 With Alum Lower Dose 0.75 ml injection of VLA15 w/ alum applied at Days 1, 57, and 180 in the Main study phase. VLA15 is a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate. Participants of this arm did not enter booster phase. | 97 |
| VLA15 With Alum Higher Dose 1 ml injection of VLA15 w/ alum applied at Days 1, 57, and 180 in the Main study phase. VLA15 is a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate. Participants after completing main study, upon consent were randomized to receive either VLA15 with Alum higher dose arm or Placebo in booster phase. | 98 |
| Placebo 1 ml injection of placebo applied at Days 1, 57, and 180 in the Main study phase. Placebo: phosphate buffered saline (PBS) solution. Participants of this arm did not enter booster phase. | 51 |
| Total | 246 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Booster Phase (Approx. 12 Months) | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 |
| Main Study Phase (18 Months) | Lost to Follow-up | 5 | 5 | 3 | 0 | 0 |
| Main Study Phase (18 Months) | Moved from study area | 2 | 1 | 0 | 0 | 0 |
| Main Study Phase (18 Months) | Other | 1 | 1 | 0 | 0 | 0 |
| Main Study Phase (18 Months) | Withdrawal by Subject | 0 | 7 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | VLA15 With Alum Higher Dose | Total | VLA15 With Alum Lower Dose | Placebo |
|---|---|---|---|---|
| Age, Continuous Booster Phase: Placebo | 38.8 years STANDARD_DEVIATION 13.5 | 38.8 years STANDARD_DEVIATION 13.5 | — | — |
| Age, Continuous Booster Phase: VLA15 with Alum higher dose | 46.5 years STANDARD_DEVIATION 13.15 | 46.5 years STANDARD_DEVIATION 13.15 | — | — |
| Age, Continuous Main Study Phase | 43.0 years STANDARD_DEVIATION 12.76 | 43.6 years STANDARD_DEVIATION 12.68 | 43.5 years STANDARD_DEVIATION 12.61 | 45.0 years STANDARD_DEVIATION 12.79 |
| Race (NIH/OMB) Booster Phase: Placebo American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Booster Phase: Placebo Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Booster Phase: Placebo Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Booster Phase: Placebo More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Booster Phase: Placebo Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Booster Phase: Placebo Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Booster Phase: Placebo White | 19 Participants | 19 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Booster Phase: VLA15 with Alum higher dose American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Booster Phase: VLA15 with Alum higher dose Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Booster Phase: VLA15 with Alum higher dose Black or African American | 4 Participants | 4 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Booster Phase: VLA15 with Alum higher dose More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Booster Phase: VLA15 with Alum higher dose Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Booster Phase: VLA15 with Alum higher dose Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Booster Phase: VLA15 with Alum higher dose White | 34 Participants | 34 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Main Study Phase American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Main Study Phase Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Main Study Phase Black or African American | 4 Participants | 8 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Main Study Phase More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Main Study Phase Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Main Study Phase Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Main Study Phase White | 93 Participants | 235 Participants | 91 Participants | 51 Participants |
| Sex: Female, Male Booster Phase: Placebo Female | 7 Participants | 7 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Booster Phase: Placebo Male | 12 Participants | 12 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Booster Phase: VLA15 with Alum higher dose Female | 23 Participants | 23 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Booster Phase: VLA15 with Alum higher dose Male | 16 Participants | 16 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Main Study Phase Female | 50 Participants | 133 Participants | 49 Participants | 34 Participants |
| Sex: Female, Male Main Study Phase Male | 48 Participants | 113 Participants | 48 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 98 | 0 / 51 | 0 / 39 | 0 / 19 |
| other Total, other adverse events | 94 / 97 | 97 / 98 | 40 / 51 | 35 / 39 | 11 / 19 |
| serious Total, serious adverse events | 4 / 97 | 4 / 98 | 2 / 51 | 3 / 39 | 0 / 19 |
Outcome results
Primary
GMTs for IgG Against Each OspA Serotype
Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) against each Outer Surface Protein A (OspA) serotype ST1 to ST6, determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 208 (Month 7)
Time frame: Day 208 (Month 7)
Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype | ST1 Day 208 | 278.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype | ST2 Day 208 | 545.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype | ST3 Day 208 | 520.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype | ST4 Day 208 | 332.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype | ST5 Day 208 | 332.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype | ST6 Day 208 | 339.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype | ST6 Day 208 | 345.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype | ST1 Day 208 | 274.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype | ST4 Day 208 | 367.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype | ST5 Day 208 | 358.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype | ST2 Day 208 | 579.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype | ST3 Day 208 | 596.8 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype | ST2 Day 208 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype | ST3 Day 208 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype | ST6 Day 208 | 21.4 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype | ST4 Day 208 | 21.3 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype | ST1 Day 208 | 21.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype | ST5 Day 208 | 20.0 Units per milliliter (U/mL) |
Secondary
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
Geometric Mean Fold Rise (GMFR) as compared to baseline for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18).
Time frame: Day 1 (baseline from where comparison was done), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 180 | 1.8 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 57 | 1.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 85 | 3.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 180 | 1.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 208 | 12.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 365 | 2.3 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 545 | 1.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 85 | 7.8 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 208 | 26.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 365 | 4.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 545 | 2.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 29 | 1.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 85 | 8.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 180 | 1.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 208 | 25.6 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 365 | 3.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 545 | 2.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 85 | 3.8 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 180 | 1.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 208 | 16.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 365 | 2.6 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 545 | 1.7 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 85 | 4.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 180 | 1.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 208 | 15.8 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 365 | 2.6 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 545 | 1.7 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 85 | 3.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 180 | 1.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 208 | 14.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 365 | 2.7 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 545 | 1.6 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 85 | 5.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 365 | 2.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 85 | 10.9 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 180 | 2.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 208 | 16.7 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 208 | 29.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 545 | 1.4 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 365 | 3.7 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 545 | 1.6 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 85 | 5.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 545 | 1.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 180 | 1.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 57 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 208 | 18.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 365 | 2.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 365 | 2.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 545 | 1.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 85 | 4.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 85 | 3.7 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 180 | 1.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 57 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 208 | 13.6 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 365 | 1.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 545 | 1.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 29 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 57 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 180 | 1.4 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 85 | 9.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 180 | 1.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 180 | 1.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 208 | 29.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 365 | 3.6 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 208 | 17.9 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 545 | 1.7 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 180 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 29 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 29 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 545 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 29 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 57 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 85 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 180 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 85 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 365 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 57 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 180 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 29 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 57 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 208 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 85 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 85 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 365 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 545 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 365 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 545 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 208 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 180 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 29 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 208 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 85 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 57 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 29 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 208 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 85 | 1.1 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 57 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 180 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 180 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 365 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 365 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 208 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 57 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 545 | 1.1 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 365 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 545 | 0.9 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 208 | 1.0 Fold Rise |
| Placebo | GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 545 | 1.1 Fold Rise |
Secondary
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
GMFR as compared to baseline for IgG against each Osp serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 were reported in this outcome measure. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Time frame: Day 1 (baseline from where comparison was done), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
Population: Booster PP population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity) and who were enrolled into the booster phase despite exclusion from the PP population of main study phase. Here, Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Month 24 | 6.7 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Day 57 | 1.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Day 545 | 1.6 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Day 85 | 5.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Day 57 | 1.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Day 180 | 1.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Month 19 | 109.7 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Day 208 | 18.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Month 30 | 2.6 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Day 365 | 2.3 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Month 24 | 12.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Day 545 | 1.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Day 365 | 1.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Month 19 | 79.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Month 30 | 4.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Month 24 | 9.7 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Day 29 | 1.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Month 30 | 3.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Day 29 | 1.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Day 180 | 1.3 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Day 57 | 1.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Day 57 | 1.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Day 85 | 5.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Day 57 | 1.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Day 180 | 1.3 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Day 85 | 11.8 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Day 208 | 18.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Day 545 | 1.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Day 365 | 2.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Day 180 | 2.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Day 545 | 1.3 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Day 85 | 11.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Month 19 | 75.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Day 208 | 31.6 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Month 24 | 8.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Day 85 | 3.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Month 30 | 3.7 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Day 365 | 3.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Day 29 | 1.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Day 180 | 2.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Day 57 | 1.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Day 545 | 1.6 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Day 85 | 3.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Month 19 | 62.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Day 180 | 1.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Month 19 | 95.8 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Day 208 | 16.8 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Day 208 | 30.3 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Day 365 | 2.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Month 24 | 13.3 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Day 545 | 1.3 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Day 208 | 14.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Month 19 | 67.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Month 30 | 5.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Month 24 | 8.7 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Day 365 | 3.8 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Month 30 | 3.6 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Month 30 | 1.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Day 85 | 3.4 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Day 180 | 1.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Day 208 | 17.5 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Day 365 | 1.9 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Day 545 | 1.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Month 19 | 1.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Month 24 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Month 30 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Day 85 | 9.4 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Day 180 | 1.7 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Day 208 | 34.7 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Day 365 | 3.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Day 545 | 1.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Month 19 | 1.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Month 24 | 1.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Month 30 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Day 85 | 11.9 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Day 180 | 2.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Day 208 | 33.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Day 365 | 4.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Day 545 | 2.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Month 19 | 1.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Month 24 | 1.5 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Month 30 | 1.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Day 85 | 5.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Day 180 | 1.4 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Day 208 | 22.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Day 365 | 2.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Day 545 | 1.6 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Month 19 | 1.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Month 24 | 1.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Month 30 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Day 85 | 6.4 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Day 180 | 1.6 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Day 208 | 26.4 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Day 365 | 3.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Day 545 | 1.6 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Month 19 | 1.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Month 24 | 1.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Month 30 | 1.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Day 85 | 5.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Day 180 | 1.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Day 208 | 25.4 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Day 365 | 3.4 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Day 545 | 1.5 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Month 19 | 1.4 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Month 24 | 1.3 Fold Rise |
Secondary
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
GMFR as compared to Day 208 for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Month 19, Month 24 and Month 30. The outcome measure was planned to be analyzed for Booster PP population from Day 208 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Time frame: Day 208 (from where comparison was done), Month 19, Month 24 and Month 30
Population: Booster PP population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity) and who were enrolled into the booster phase despite exclusion from the PP population of main study phase. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Month 19 | 4.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Month 24 | 0.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Month 30 | 0.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Month 19 | 3.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Month 24 | 0.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Month 30 | 0.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Month 19 | 2.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Month 24 | 0.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Month 30 | 0.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Month 19 | 4.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Month 24 | 0.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Month 30 | 0.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Month 19 | 4.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Month 24 | 0.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Month 30 | 0.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Month 19 | 3.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Month 24 | 0.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Month 30 | 0.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Month 24 | 0.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Month 19 | 0.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Month 19 | 0.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Month 24 | 0.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Month 30 | 0.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Month 30 | 0.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Month 24 | 0.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Month 19 | 0.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Month 30 | 0.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Month 24 | 0.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Month 30 | 0.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Month 30 | 0.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Month 24 | 0.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Month 19 | 0.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Month 19 | 0.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Month 24 | 0.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Month 19 | 0.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Month 30 | 0.0 Fold Rise |
Secondary
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
GMFR as compared to Month 18 (pre-booster) for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Month 19, Month 24 and Month 30. The outcome measure was planned to be analyzed for Booster PP population.
Time frame: Month 18 (from where comparison was done), Month 19, Month 24 and Month 30
Population: Booster PP population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity) and who were enrolled into the booster phase despite exclusion from the PP population of main study phase. Here, Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Month 19 | 51.3 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Month 24 | 5.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Month 30 | 2.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Month 19 | 69.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Month 24 | 8.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Month 30 | 2.8 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Month 19 | 61.7 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Month 24 | 8.6 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Month 30 | 3.3 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Month 19 | 57.7 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Month 24 | 7.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Month 30 | 2.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Month 19 | 60.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Month 24 | 6.8 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Month 30 | 3.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Month 19 | 53.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Month 24 | 6.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Month 30 | 2.9 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Month 24 | 0.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Month 19 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Month 19 | 0.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Month 24 | 0.9 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Month 30 | 0.9 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST1 Month 30 | 0.9 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Month 24 | 0.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Month 19 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Month 30 | 0.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Month 24 | 0.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST4 Month 30 | 0.7 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST2 Month 30 | 0.6 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Month 24 | 0.9 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Month 19 | 0.9 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST5 Month 19 | 0.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Month 24 | 0.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST6 Month 19 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population | ST3 Month 30 | 0.7 Fold Rise |
Secondary
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
GMFR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 18 - 49 years.
Time frame: Day 1 (baseline), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 85 | 2.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 365 | 2.6 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 180 | 1.3 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 208 | 16.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 180 | 2.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 208 | 13.6 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 85 | 8.7 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 365 | 2.3 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 180 | 1.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 29 | 1.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 545 | 1.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 180 | 1.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 545 | 2.3 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 29 | 1.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 85 | 4.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 365 | 4.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 208 | 27.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 180 | 1.8 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 85 | 4.3 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 180 | 1.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 57 | 1.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 208 | 28.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 85 | 3.7 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 208 | 15.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 545 | 1.8 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 545 | 1.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 365 | 2.6 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 545 | 1.7 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 365 | 3.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 365 | 2.6 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 545 | 2.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 85 | 7.6 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 208 | 17.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 545 | 1.4 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 85 | 9.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 57 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 208 | 31.7 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 545 | 1.7 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 85 | 5.5 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 180 | 1.4 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 545 | 1.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 57 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 208 | 16.4 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 545 | 1.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 85 | 4.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 180 | 1.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 208 | 14.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 365 | 1.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 545 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 29 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 57 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 180 | 1.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 208 | 29.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 365 | 3.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 545 | 1.6 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 85 | 11.7 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 180 | 2.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 365 | 3.6 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 208 | 19.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 365 | 2.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 57 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 85 | 5.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 180 | 1.4 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 208 | 18.5 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 365 | 2.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 85 | 4.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 180 | 1.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 365 | 2.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 365 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 365 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 85 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 365 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 57 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 208 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 208 | 1.1 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 545 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 29 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 365 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 208 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 57 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 545 | 1.1 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 545 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 29 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 29 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 180 | 1.1 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 57 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 57 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 85 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 180 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 85 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 57 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 180 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 85 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 85 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 208 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 29 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 180 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 365 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 545 | 0.9 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 29 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 545 | 1.1 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 365 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 29 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 57 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 208 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 208 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 85 | 1.1 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 180 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 545 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 180 | 1.0 Fold Rise |
Secondary
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
GMFR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 50 - 65 years.
Time frame: Day 1 (baseline), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 365 | 2.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 208 | 22.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 85 | 3.6 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 180 | 1.3 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 208 | 14.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 365 | 2.6 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 545 | 1.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 85 | 3.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 85 | 3.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 180 | 1.3 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 208 | 14.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 85 | 3.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 180 | 1.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 208 | 13.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 180 | 1.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 365 | 2.8 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 545 | 1.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 208 | 11.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 365 | 2.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 545 | 1.2 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 180 | 1.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 85 | 8.1 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 208 | 24.6 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 545 | 1.8 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 365 | 4.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 545 | 1.9 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 545 | 1.5 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 85 | 7.4 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 180 | 1.7 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Lower Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 365 | 3.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 545 | 1.4 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 545 | 1.5 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 365 | 4.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 208 | 12.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 85 | 3.9 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 29 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 208 | 26.7 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 365 | 2.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 85 | 4.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 180 | 1.5 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 180 | 1.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 365 | 2.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 365 | 4.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 208 | 16.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 365 | 1.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 545 | 1.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 545 | 1.7 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 180 | 1.9 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 29 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 85 | 4.5 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 57 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 85 | 9.5 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 180 | 1.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 85 | 3.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 57 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 85 | 8.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 57 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 545 | 1.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 208 | 16.9 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 180 | 1.7 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 208 | 17.3 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 57 | 1.1 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 29 | 1.0 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 365 | 2.7 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 180 | 1.2 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 208 | 28.8 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 545 | 1.5 Fold Rise |
| VLA15 With Alum Higher Dose | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 57 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 545 | 0.9 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 57 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 180 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 365 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 29 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 208 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 365 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 545 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 29 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 85 | 0.9 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 180 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 29 | 1.1 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 57 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 85 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 180 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 208 | 0.9 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 365 | 0.9 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 545 | 0.9 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 29 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 85 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 180 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 208 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 365 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 545 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 29 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 57 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 85 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 208 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 365 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 545 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 29 | 1.1 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 57 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 85 | 1.1 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 180 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 208 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 545 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 57 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 85 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 180 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 57 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 208 | 1.0 Fold Rise |
| Placebo | GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 365 | 1.0 Fold Rise |
Secondary
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 365 (Month 12) and 545 (Month 18).
Time frame: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 365 (Month 12) and Day 545 (Month 18)
Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 85 | 162.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 29 | 22.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 57 | 22.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 85 | 64.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 180 | 26.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 365 | 48.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 545 | 29.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 1 | 20.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 29 | 21.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 57 | 21.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 1 | 21.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 180 | 38.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 365 | 87.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 545 | 44.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 1 | 20.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 29 | 21.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 57 | 20.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 85 | 166.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 180 | 38.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 365 | 78.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 545 | 39.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 1 | 20.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 29 | 20.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 57 | 21.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 85 | 79.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 180 | 28.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 365 | 53.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 545 | 35.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 1 | 21.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 29 | 21.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 57 | 21.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 85 | 87.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 180 | 29.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 365 | 53.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 545 | 35.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 1 | 22.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 29 | 23.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 57 | 23.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 85 | 79.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 180 | 32.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 365 | 61.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 545 | 36.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 85 | 217.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 1 | 20.2 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 365 | 42.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 57 | 22.2 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 29 | 20.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 1 | 20.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 57 | 21.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 180 | 28.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 1 | 20.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 85 | 75.2 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 29 | 20.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 180 | 41.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 180 | 24.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 57 | 20.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 29 | 20.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 365 | 37.2 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 57 | 20.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 545 | 27.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 545 | 23.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 545 | 27.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 85 | 100.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 365 | 74.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 57 | 21.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 29 | 21.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 85 | 100.2 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 29 | 21.2 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 57 | 22.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 180 | 27.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 85 | 84.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 85 | 183.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 180 | 35.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 365 | 43.2 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 545 | 32.2 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 365 | 71.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 365 | 46.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 180 | 27.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 545 | 33.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 545 | 27.3 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 545 | 21.1 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 1 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 545 | 20.7 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 29 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 57 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 365 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 85 | 20.7 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 180 | 20.4 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 365 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 545 | 20.4 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST3 Day 545 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 180 | 21.7 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 1 | 20.5 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 29 | 20.8 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 1 | 21.2 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 57 | 21.2 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 85 | 21.6 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 180 | 21.3 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 29 | 21.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 365 | 21.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST4 Day 545 | 22.4 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 1 | 21.8 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 29 | 22.1 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 57 | 21.6 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 1 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 85 | 21.7 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 57 | 21.6 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 180 | 21.5 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 365 | 21.4 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 29 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST1 Day 545 | 20.6 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 365 | 21.5 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 1 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 29 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 57 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 57 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 85 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 85 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 180 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST6 Day 85 | 20.7 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST2 Day 365 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype During the Main Study Phase | ST5 Day 180 | 20.0 Units per milliliter (U/mL) |
Secondary
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24, and Month 30. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Time frame: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
Population: Booster per-protocol (PP) population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity) and who were enrolled into the booster phase despite exclusion from the PP population of main study phase. Here, Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Day 365 | 46.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Day 85 | 235.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Month 24 | 258.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Day 180 | 47.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Day 208 | 631.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Day 1 | 20.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Day 365 | 78.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Day 365 | 39.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Day 85 | 78.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Month 19 | 1916.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Day 545 | 31.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Month 24 | 265.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Month 19 | 1661.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Month 30 | 101.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Day 545 | 24.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Day 1 | 20.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Day 29 | 20.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Day 29 | 21.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Month 19 | 1277.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Day 57 | 22.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Day 29 | 22.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Day 85 | 108.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Month 24 | 137.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Day 180 | 30.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Month 30 | 54.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Day 208 | 376.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Day 365 | 47.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Day 57 | 23.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Day 545 | 28.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Day 29 | 23.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Day 180 | 27.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Month 24 | 200.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Day 365 | 76.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Month 30 | 72.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Day 85 | 219.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Day 57 | 23.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Day 85 | 100.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Month 19 | 1507.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Day 180 | 26.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Day 180 | 41.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Day 208 | 370.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Day 57 | 22.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Day 365 | 43.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Day 545 | 25.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Month 24 | 170.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Day 208 | 606.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Month 30 | 74.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Day 1 | 20.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Day 545 | 31.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Day 29 | 22.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Month 19 | 2194.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Day 57 | 24.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Day 85 | 82.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Month 30 | 89.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Day 180 | 29.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Day 208 | 351.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Day 545 | 26.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Month 19 | 1406.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Day 208 | 292.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Month 24 | 181.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Day 57 | 21.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Month 30 | 76.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Day 85 | 67.2 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Day 180 | 24.2 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Month 24 | 22.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Day 208 | 694.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Day 365 | 75.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Month 19 | 36.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Day 365 | 59.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Day 545 | 31.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Month 19 | 25.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Day 208 | 509.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Day 365 | 67.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Month 30 | 23.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Day 208 | 349.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Day 365 | 37.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Day 545 | 24.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Month 19 | 23.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Month 30 | 22.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Day 85 | 187.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Day 180 | 33.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Day 545 | 35.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Month 24 | 26.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST2 Month 30 | 21.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST1 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Day 85 | 237.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Day 180 | 43.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Day 208 | 666.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Day 365 | 81.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Day 545 | 39.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Month 19 | 35.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Month 24 | 29.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST3 Month 30 | 24.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Day 85 | 100.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Day 180 | 28.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Day 208 | 455.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Day 365 | 46.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Day 545 | 31.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Month 19 | 26.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Month 24 | 24.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST4 Month 30 | 22.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Day 85 | 127.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Day 180 | 32.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Day 208 | 528.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Month 24 | 23.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST5 Month 30 | 23.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Day 85 | 116.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Day 180 | 36.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Day 545 | 29.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Month 19 | 28.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population | ST6 Month 24 | 25.8 Units per milliliter (U/mL) |
Secondary
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 stratified by age group: 18 - 49 years. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Time frame: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
Population: Booster PP population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity) and who were enrolled into the booster phase despite exclusion from the PP population of main study phase. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 1 | 21.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 85 | 103.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 29 | 22.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Month 19 | 2199.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 57 | 23.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 180 | 29.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 85 | 134.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 180 | 43.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 180 | 31.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 208 | 335.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 208 | 432.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Month 24 | 230.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 365 | 45.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 365 | 39.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 545 | 29.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 57 | 25.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Month 19 | 1817.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 545 | 24.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Month 24 | 191.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Month 30 | 72.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Month 30 | 66.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Month 19 | 1551.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 208 | 608.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 29 | 21.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Month 24 | 142.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 57 | 23.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 85 | 120.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Month 30 | 56.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 180 | 27.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 57 | 23.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 208 | 380.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 29 | 24.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 365 | 42.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 85 | 280.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 545 | 25.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Month 19 | 1600.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 180 | 52.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Month 24 | 160.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 365 | 65.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Month 30 | 78.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 208 | 710.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 1 | 21.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 1 | 20.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 29 | 22.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 365 | 78.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 57 | 27.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 85 | 252.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 85 | 90.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 545 | 30.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 180 | 28.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 29 | 21.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 208 | 346.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Month 19 | 1997.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 365 | 42.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 545 | 28.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 545 | 25.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Month 24 | 246.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Month 19 | 1449.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 57 | 22.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Month 24 | 163.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Month 30 | 96.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Month 30 | 69.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Month 30 | 22.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 85 | 213.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 180 | 36.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 208 | 761.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 365 | 88.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 545 | 38.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Month 19 | 40.2 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Month 24 | 25.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Month 30 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 85 | 62.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 180 | 21.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 208 | 335.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 365 | 34.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 545 | 21.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Month 19 | 21.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Month 24 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 85 | 266.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 180 | 45.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 208 | 696.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 365 | 91.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 545 | 41.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Month 19 | 37.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Month 24 | 28.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Month 30 | 23.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 85 | 105.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 180 | 29.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 208 | 458.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 365 | 47.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 545 | 28.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Month 19 | 25.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Month 24 | 22.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Month 30 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 85 | 122.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 180 | 31.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 208 | 506.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 365 | 55.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 545 | 31.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Month 19 | 24.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Month 24 | 22.2 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Month 30 | 22.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 85 | 121.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 180 | 34.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 208 | 502.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 365 | 63.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 545 | 28.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Month 19 | 28.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Month 24 | 25.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Month 30 | 20.0 Units per milliliter (U/mL) |
Secondary
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 stratified by age group: 50 - 65 years. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Time frame: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
Population: Booster PP population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity) and who were enrolled into the booster phase despite exclusion from the PP population of main study phase. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 208 | 602.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 57 | 22.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 85 | 53.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 180 | 25.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 208 | 236.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 365 | 40.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 545 | 25.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Month 19 | 959.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Month 24 | 130.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Month 30 | 50.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 29 | 21.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 85 | 178.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 180 | 38.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 365 | 96.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 545 | 36.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Month 19 | 2187.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Month 24 | 306.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Month 30 | 121.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 85 | 181.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 180 | 40.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 208 | 530.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 365 | 79.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 545 | 32.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Month 19 | 1803.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Month 24 | 297.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Month 30 | 109.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 85 | 79.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 180 | 28.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 208 | 306.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 365 | 50.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 545 | 28.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Month 19 | 1455.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Month 24 | 214.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Month 30 | 81.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 29 | 23.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 57 | 22.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 85 | 77.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 180 | 25.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 208 | 356.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 365 | 45.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 545 | 24.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Month 19 | 1381.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Month 24 | 186.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Month 30 | 68.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 29 | 21.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 57 | 21.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 85 | 71.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 180 | 30.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 208 | 360.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 365 | 53.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 545 | 27.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Month 19 | 1346.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Month 24 | 210.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Month 30 | 86.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 208 | 584.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Month 30 | 28.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 85 | 78.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 365 | 71.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 180 | 31.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 208 | 386.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 85 | 105.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 365 | 44.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 85 | 90.2 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 545 | 32.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 545 | 30.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Month 19 | 30.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 180 | 25.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Month 24 | 28.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 545 | 30.2 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Month 30 | 28.2 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 208 | 447.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Month 19 | 28.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 365 | 44.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 180 | 42.2 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 85 | 137.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 545 | 39.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 180 | 26.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Month 24 | 27.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 208 | 557.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Month 19 | 29.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 365 | 51.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Month 24 | 27.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 545 | 30.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Month 24 | 29.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Month 19 | 29.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Month 30 | 27.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Month 24 | 28.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Month 30 | 28.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Month 30 | 27.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 208 | 525.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 85 | 179.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Month 19 | 28.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 180 | 39.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 208 | 599.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 365 | 61.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 85 | 139.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 545 | 34.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 365 | 78.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Month 19 | 31.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 180 | 33.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Month 24 | 30.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Month 30 | 29.2 Units per milliliter (U/mL) |
Secondary
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 18 - 49 years.
Time frame: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 208 | 358.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 29 | 21.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 57 | 22.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 85 | 60.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 180 | 27.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 208 | 284.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 365 | 47.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 545 | 30.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 1 | 20.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 29 | 21.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 57 | 20.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 85 | 155.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 180 | 36.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 208 | 551.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 365 | 82.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 545 | 46.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 1 | 20.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 29 | 21.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 57 | 21.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 85 | 178.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 180 | 40.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 208 | 573.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 365 | 80.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 545 | 40.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 29 | 21.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 57 | 21.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 85 | 84.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 180 | 29.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 208 | 365.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 365 | 55.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 545 | 40.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 1 | 21.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 29 | 21.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 57 | 21.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 85 | 91.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 180 | 30.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 1 | 20.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 365 | 54.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 545 | 37.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 1 | 23.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 29 | 24.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 57 | 23.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 85 | 86.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 180 | 32.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 208 | 362.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 365 | 61.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 545 | 41.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 1 | 21.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 29 | 20.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 1 | 20.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 29 | 21.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 29 | 20.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 29 | 20.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 1 | 20.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 180 | 27.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 57 | 20.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 208 | 633.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 57 | 21.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 85 | 83.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 57 | 21.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 57 | 21.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 180 | 25.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 545 | 24.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 85 | 111.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 208 | 291.2 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 365 | 41.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 85 | 106.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 365 | 37.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 57 | 22.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 180 | 27.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 545 | 23.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 365 | 71.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 208 | 393.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 180 | 27.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 29 | 21.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 545 | 33.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 57 | 22.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 365 | 42.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 208 | 337.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 85 | 195.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 180 | 42.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 208 | 371.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 180 | 36.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 85 | 85.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 545 | 28.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 208 | 581.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 1 | 20.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 545 | 26.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 365 | 66.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 365 | 42.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 545 | 32.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 85 | 233.5 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 545 | 21.6 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 1 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 29 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 57 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 545 | 20.6 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 365 | 21.6 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 180 | 20.6 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 208 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 1 | 21.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 365 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 1 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 545 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 1 | 20.8 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 29 | 20.7 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 29 | 20.9 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 57 | 21.8 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 85 | 21.7 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 180 | 21.8 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 57 | 21.6 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 208 | 22.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 545 | 21.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 365 | 21.5 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 545 | 23.6 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 85 | 21.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 1 | 21.2 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 29 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 29 | 21.2 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 57 | 21.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 85 | 21.3 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 57 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 180 | 21.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 180 | 21.6 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 208 | 20.6 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 365 | 21.2 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 85 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 545 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 85 | 21.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 1 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 29 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 180 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 57 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 85 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 180 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 208 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 208 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 208 | 21.2 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 365 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 365 | 20.0 Units per milliliter (U/mL) |
Secondary
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 50 - 65 years.
Time frame: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 57 | 22.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 545 | 41.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 85 | 69.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 180 | 32.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 545 | 30.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 208 | 305.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 365 | 60.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 29 | 20.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 1 | 22.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 29 | 23.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 57 | 23.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 208 | 440.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 85 | 71.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 57 | 20.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 180 | 24.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 208 | 269.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 365 | 49.2 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 85 | 147.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 545 | 27.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 1 | 21.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 29 | 21.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 180 | 34.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 57 | 20.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 365 | 75.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 57 | 21.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 545 | 36.6 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 1 | 20.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 85 | 175.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 57 | 20.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 85 | 71.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 29 | 20.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 180 | 25.7 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 180 | 40.5 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 208 | 283.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 365 | 51.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 545 | 28.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 85 | 81.4 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 208 | 534.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 180 | 27.3 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 208 | 293.1 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 365 | 52.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 545 | 31.0 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 365 | 95.9 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 1 | 21.8 Units per milliliter (U/mL) |
| VLA15 With Alum Lower Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 29 | 22.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 208 | 534.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 57 | 21.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 208 | 324.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 180 | 34.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 85 | 82.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 545 | 34.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 365 | 80.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 180 | 31.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 208 | 577.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 365 | 44.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 208 | 361.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 545 | 30.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 57 | 21.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 365 | 56.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 545 | 31.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 1 | 20.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 57 | 21.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 180 | 25.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 57 | 21.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 29 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 365 | 43.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 85 | 61.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 85 | 89.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 180 | 24.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 57 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 85 | 163.4 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 208 | 246.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 29 | 21.9 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 29 | 21.5 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 365 | 36.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 85 | 82.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 365 | 80.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 545 | 24.8 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 85 | 190.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 180 | 26.7 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 1 | 20.0 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 545 | 26.3 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 545 | 27.6 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 29 | 22.1 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 208 | 337.2 Units per milliliter (U/mL) |
| VLA15 With Alum Higher Dose | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 180 | 38.1 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 29 | 24.4 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 365 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 180 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 1 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 29 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 57 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 85 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 180 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 208 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 365 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 545 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 1 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 29 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 57 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 85 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 208 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 365 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 545 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 1 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 29 | 21.1 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 57 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 85 | 21.3 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 180 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 208 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 57 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 85 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 208 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 365 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 545 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 1 | 21.7 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 29 | 21.3 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 57 | 21.7 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 85 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 180 | 21.9 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 208 | 21.8 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 365 | 21.4 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 545 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 545 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 1 | 23.1 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 57 | 23.2 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 85 | 22.6 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 180 | 22.5 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 208 | 21.9 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 365 | 21.8 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 545 | 21.9 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 1 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 29 | 20.0 Units per milliliter (U/mL) |
| Placebo | GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 180 | 20.0 Units per milliliter (U/mL) |
Secondary
Percentage of Participants Adverse Event of Special Interest (AESIs) During the Main Study Phase
AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day 1 of vaccination up to Day 545 (Month 18)
Population: Safety population included all participants who entered into the study and received at least 1 dose of vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VLA15 With Alum Lower Dose | Percentage of Participants Adverse Event of Special Interest (AESIs) During the Main Study Phase | 2.1 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants Adverse Event of Special Interest (AESIs) During the Main Study Phase | 0.0 Percentage of Participants |
| Placebo | Percentage of Participants Adverse Event of Special Interest (AESIs) During the Main Study Phase | 0.0 Percentage of Participants |
Secondary
Percentage of Participants With Adverse Event of Special Interest (AESIs) During the Entire Booster Phase
AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months)
Population: Booster safety population included all participants who received the booster vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VLA15 With Alum Lower Dose | Percentage of Participants With Adverse Event of Special Interest (AESIs) During the Entire Booster Phase | 2.6 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Adverse Event of Special Interest (AESIs) During the Entire Booster Phase | 0.0 Percentage of Participants |
Secondary
Percentage of Participants With Related AESIs During the Entire Booster Phase
AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months)
Population: Booster safety population included all participants who received the booster vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VLA15 With Alum Lower Dose | Percentage of Participants With Related AESIs During the Entire Booster Phase | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Related AESIs During the Entire Booster Phase | 0.0 Percentage of Participants |
Secondary
Percentage of Participants With Related AESIs During the Main Study Phase
AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day 1 of vaccination up to Day 545 (Month 18)
Population: Safety population included all participants who entered into the study and received at least 1 dose of vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VLA15 With Alum Lower Dose | Percentage of Participants With Related AESIs During the Main Study Phase | 1.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Related AESIs During the Main Study Phase | 0.0 Percentage of Participants |
| Placebo | Percentage of Participants With Related AESIs During the Main Study Phase | 0.0 Percentage of Participants |
Secondary
Percentage of Participants With Related SAEs During the Entire Booster Phase
SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months)
Population: Booster safety population included all participants who received the booster vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VLA15 With Alum Lower Dose | Percentage of Participants With Related SAEs During the Entire Booster Phase | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Related SAEs During the Entire Booster Phase | 0.0 Percentage of Participants |
Secondary
Percentage of Participants With Related SAEs During the Main Study Phase
SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day 1 of vaccination up to Day 545 (Month 18)
Population: Safety population included all participants who entered into the study and received at least 1 dose of vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VLA15 With Alum Lower Dose | Percentage of Participants With Related SAEs During the Main Study Phase | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Related SAEs During the Main Study Phase | 0.0 Percentage of Participants |
| Placebo | Percentage of Participants With Related SAEs During the Main Study Phase | 0.0 Percentage of Participants |
Secondary
Percentage of Participants With Related Unsolicited AEs During the Booster Phase up to Month 19
An unsolicited AE included any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month)
Population: Booster safety population included all participants who received the booster vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VLA15 With Alum Lower Dose | Percentage of Participants With Related Unsolicited AEs During the Booster Phase up to Month 19 | 5.1 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Related Unsolicited AEs During the Booster Phase up to Month 19 | 0.0 Percentage of Participants |
Secondary
Percentage of Participants With Related Unsolicited AEs During the Main Study Phase
An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day 1 of vaccination up to Day 545 (Month 18)
Population: Safety population included all participants who entered into the study and received at least 1 dose of vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VLA15 With Alum Lower Dose | Percentage of Participants With Related Unsolicited AEs During the Main Study Phase | 18.6 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Related Unsolicited AEs During the Main Study Phase | 22.4 Percentage of Participants |
| Placebo | Percentage of Participants With Related Unsolicited AEs During the Main Study Phase | 7.8 Percentage of Participants |
Secondary
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase
Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs during booster phase stratified by age group 18-49 years and 50-65 years were reported. SAE: any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. AESI: any AEs of scientific/medical concern specific to study vaccine; Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AE: any untoward medical occurrence in participant associated with use of study vaccine, whether or not related to study vaccine, reported in addition to solicited and any solicited symptom with onset outside specified period of follow-up.
Time frame: SAEs and AESIs: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months); AEs: From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month)
Population: Booster safety population included all participants who received the booster vaccination. Here Number Analyzed signifies participants evaluable for this outcome measure at specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase | SAE: 18-49 Years | 4.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase | SAE: 50-65 Years | 11.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase | AESI: 18-49 Years | 0.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase | AESI: 50-65 Years | 5.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase | Solicited AE: 18-49 Years | 86.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase | Solicited AE: 50-65 Years | 94.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase | Unsolicited AE: 18-49 Years | 9.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase | Unsolicited AE: 50-65 Years | 23.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase | Unsolicited AE: 50-65 Years | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase | SAE: 18-49 Years | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase | Solicited AE: 18-49 Years | 42.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase | SAE: 50-65 Years | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase | Unsolicited AE: 18-49 Years | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase | AESI: 18-49 Years | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase | Solicited AE: 50-65 Years | 80.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase | AESI: 50-65 Years | 0.0 Percentage of Participants |
Secondary
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase
Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs during main study phase stratified by age group 18-49 years and 50-65 years were reported. SAE: any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. AESI: any AEs of scientific/medical concern specific to study vaccine. Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AE: any untoward medical occurrence in participant associated with use of study vaccine, whether or not related to study vaccine, reported in addition to solicited and any solicited symptom with onset outside specified period of follow-up. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day 1 of vaccination up to Day 545 (Month 18)
Population: Safety population included all participants who entered into the study and received at least 1 dose of vaccination. Here Number Analyzed signifies participants evaluable for this outcome measure at specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | SAE: 50-65 Years | 6.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | SAE: 18-49 Years | 3.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | AESI: 18-49 Years | 3.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | AESI: 50-65 Years | 0.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | Solicited AE: 18-49 Years | 95.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | Solicited AE: 50-65 Years | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | Unsolicited AE: 18-49 Years | 64.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | Unsolicited AE: 50-65 Years | 69.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | Unsolicited AE: 50-65 Years | 61.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | SAE: 18-49 Years | 3.1 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | Solicited AE: 50-65 Years | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | AESI: 18-49 Years | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | AESI: 50-65 Years | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | SAE: 50-65 Years | 5.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | Solicited AE: 18-49 Years | 96.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | Unsolicited AE: 18-49 Years | 65.6 Percentage of Participants |
| Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | Solicited AE: 18-49 Years | 59.4 Percentage of Participants |
| Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | AESI: 50-65 Years | 0.0 Percentage of Participants |
| Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | Solicited AE: 50-65 Years | 73.7 Percentage of Participants |
| Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | SAE: 18-49 Years | 0.0 Percentage of Participants |
| Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | SAE: 50-65 Years | 10.5 Percentage of Participants |
| Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | Unsolicited AE: 18-49 Years | 59.4 Percentage of Participants |
| Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | AESI: 18-49 Years | 0.0 Percentage of Participants |
| Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase | Unsolicited AE: 50-65 Years | 84.2 Percentage of Participants |
Secondary
Percentage of Participants With SAEs During the Entire Booster Phase
SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months)
Population: Booster safety population included all participants who received the booster vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VLA15 With Alum Lower Dose | Percentage of Participants With SAEs During the Entire Booster Phase | 7.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With SAEs During the Entire Booster Phase | 0.0 Percentage of Participants |
Secondary
Percentage of Participants With Serious Adverse Events (SAEs) During the Main Study Phase
SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day 1 of vaccination up to Day 545 (Month 18)
Population: Safety population included all participants who entered into the study and received at least 1 dose of vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VLA15 With Alum Lower Dose | Percentage of Participants With Serious Adverse Events (SAEs) During the Main Study Phase | 4.1 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Serious Adverse Events (SAEs) During the Main Study Phase | 4.1 Percentage of Participants |
| Placebo | Percentage of Participants With Serious Adverse Events (SAEs) During the Main Study Phase | 3.9 Percentage of Participants |
Secondary
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Vaccination
Solicited local AEs included pain, tenderness, induration (hardening), swelling and erythema (redness). Solicited systemic AEs included headache, myalgia (muscle pain), arthralgia (joint pain), fever (oral body temperature), flu-like symptoms, nausea, vomiting and fatigue. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: Within 7 days after booster vaccination
Population: Booster safety population included all participants who received the booster vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Vaccination | Solicited local AEs | 89.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Vaccination | Solicited systemic AEs | 51.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Vaccination | Solicited local AEs | 42.1 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Vaccination | Solicited systemic AEs | 31.6 Percentage of Participants |
Secondary
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase
Solicited local AEs included pain, tenderness, induration (hardening), swelling and erythema (redness). Solicited systemic AEs included headache, myalgia (muscle pain), arthralgia (joint pain), fever (oral body temperature), flu-like symptoms, nausea, vomiting and fatigue. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: Up to 7 days after Vaccination 1, 2 and 3; Up to 7 days after any vaccination
Population: Safety population included all participants who entered into the study and received at least 1 dose of vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Solicited local AE: 1st vaccination | 94.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Solicited local AE: 2nd vaccination | 80.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Any solicited systemic AE: Any vaccination | 78.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Any solicited local AE: Any vaccination | 95.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Solicited local AE: 3rd vaccination | 78.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Solicited systemic AE: 1st vaccination | 61.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Solicited systemic AE: 2nd vaccination | 47.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Solicited systemic AE: 3rd vaccination | 36.1 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Solicited systemic AE: 2nd vaccination | 40.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Solicited local AE: 3rd vaccination | 82.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Any solicited local AE: Any vaccination | 98.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Solicited local AE: 1st vaccination | 93.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Solicited local AE: 2nd vaccination | 83.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Solicited systemic AE: 3rd vaccination | 40.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Any solicited systemic AE: Any vaccination | 69.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Solicited systemic AE: 1st vaccination | 56.1 Percentage of Participants |
| Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Solicited local AE: 1st vaccination | 25.5 Percentage of Participants |
| Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Solicited local AE: 2nd vaccination | 23.5 Percentage of Participants |
| Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Solicited local AE: 3rd vaccination | 17.6 Percentage of Participants |
| Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Solicited systemic AE: 1st vaccination | 35.3 Percentage of Participants |
| Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Any solicited systemic AE: Any vaccination | 51.0 Percentage of Participants |
| Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Solicited systemic AE: 2nd vaccination | 21.6 Percentage of Participants |
| Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Solicited systemic AE: 3rd vaccination | 17.6 Percentage of Participants |
| Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase | Any solicited local AE: Any vaccination | 45.1 Percentage of Participants |
Secondary
Percentage of Participants With Unsolicited AEs During the Booster Phase up to Month 19
An unsolicited AE includes any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month)
Population: Booster safety population included all participants who received the booster vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VLA15 With Alum Lower Dose | Percentage of Participants With Unsolicited AEs During the Booster Phase up to Month 19 | 15.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Unsolicited AEs During the Booster Phase up to Month 19 | 5.3 Percentage of Participants |
Secondary
Percentage of Participants With Unsolicited AEs During the Main Study Phase
An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day 1 of vaccination up to Day 545 (Month 18)
Population: Safety population included all participants who entered into the study and received at least 1 dose of vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VLA15 With Alum Lower Dose | Percentage of Participants With Unsolicited AEs During the Main Study Phase | 66.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | Percentage of Participants With Unsolicited AEs During the Main Study Phase | 64.3 Percentage of Participants |
| Placebo | Percentage of Participants With Unsolicited AEs During the Main Study Phase | 68.6 Percentage of Participants |
Secondary
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 stratified by age group: 18 - 49 years was presented in this outcome measure. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): \>=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. The outcome measure was planned to be analyzed for Booster PP population from Day 29 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Time frame: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
Population: Booster PP population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity) and who were enrolled into the booster phase despite exclusion from the PP population of main study phase. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 29 | 4.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Month 24 | 90.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 57 | 9.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 545 | 31.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 85 | 86.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 57 | 9.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 180 | 31.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Month 19 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Month 30 | 63.6 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 365 | 54.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Month 24 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 545 | 31.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 365 | 40.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Month 19 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Month 30 | 63.6 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Month 24 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 29 | 13.6 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Month 30 | 68.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 29 | 4.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 180 | 31.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 57 | 9.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 57 | 4.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 85 | 81.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 57 | 13.6 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 180 | 27.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 85 | 90.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 208 | 95.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 545 | 13.6 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 365 | 50.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 180 | 68.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 545 | 22.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 85 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Month 19 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Month 24 | 95.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 85 | 72.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Month 30 | 90.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 365 | 77.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 29 | 4.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 180 | 50.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 57 | 18.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 545 | 31.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 85 | 68.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Month 19 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 180 | 22.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Month 19 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 208 | 95.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 365 | 40.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Month 24 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 545 | 13.6 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 208 | 95.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Month 19 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Month 30 | 90.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Month 24 | 95.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 365 | 72.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Month 30 | 72.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 29 | 4.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Month 30 | 8.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 85 | 66.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 180 | 7.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 365 | 33.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Day 545 | 7.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Month 19 | 7.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Month 24 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST1 Month 30 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 85 | 91.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 180 | 38.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 365 | 83.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Day 545 | 53.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Month 19 | 61.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Month 24 | 25.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST2 Month 30 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 85 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 180 | 53.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 365 | 83.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Day 545 | 53.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Month 19 | 53.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Month 24 | 33.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST3 Month 30 | 16.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 85 | 91.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 180 | 30.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 365 | 66.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Day 545 | 38.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Month 19 | 23.1 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Month 24 | 16.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST4 Month 30 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 85 | 91.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 180 | 38.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 365 | 66.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Day 545 | 38.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Month 19 | 15.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Month 24 | 8.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST5 Month 30 | 8.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 85 | 91.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 180 | 38.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 365 | 75.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Day 545 | 30.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Month 19 | 30.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years | ST6 Month 24 | 25.0 Percentage of Participants |
Secondary
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24, and Month 30 stratified by age group: 50 - 65 years. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): \>=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. The outcome measure was planned to be analyzed for Booster PP population from Day 29 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Time frame: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
Population: Booster PP population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity) and who were enrolled into the booster phase despite exclusion from the PP population of main study phase. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Month 19 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 365 | 80.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 85 | 73.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 180 | 33.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 545 | 40.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 208 | 92.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Month 24 | 86.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 365 | 60.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Month 19 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 545 | 26.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Month 19 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Month 24 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Month 24 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Month 30 | 46.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Month 30 | 80.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Month 30 | 86.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 29 | 13.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 85 | 53.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 57 | 13.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 85 | 73.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 29 | 6.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 180 | 20.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 365 | 46.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 365 | 46.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 85 | 86.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 545 | 13.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Month 19 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 180 | 46.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Month 24 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 57 | 6.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Month 30 | 66.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 208 | 92.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 29 | 6.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 85 | 93.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 57 | 6.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 365 | 66.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 85 | 73.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 545 | 20.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 180 | 33.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 545 | 33.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 180 | 46.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 365 | 53.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Month 19 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 545 | 20.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 180 | 26.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Month 19 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Month 24 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Month 24 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 208 | 92.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Month 30 | 73.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Month 30 | 86.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Month 30 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 85 | 80.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 180 | 40.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 365 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Day 545 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Month 19 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Month 24 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST1 Month 30 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 85 | 80.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 180 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 365 | 40.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Day 545 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Month 19 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Month 24 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST2 Month 30 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 85 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 180 | 40.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 365 | 40.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Day 545 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Month 19 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Month 24 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST3 Month 30 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 85 | 80.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 180 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 365 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 545 | 40.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Month 19 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Month 24 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Month 30 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 85 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 180 | 40.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 365 | 80.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Day 545 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Month 19 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Month 24 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST5 Month 30 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 85 | 80.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 180 | 60.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 365 | 80.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Day 545 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Month 19 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST6 Month 24 | 20.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years | ST4 Day 57 | 0.0 Percentage of Participants |
Secondary
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 18 - 49 years. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): \>=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants.
Time frame: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 365 | 69.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 365 | 61.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 545 | 46.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 29 | 1.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 545 | 20.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 85 | 73.6 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 180 | 21.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 365 | 51.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 545 | 37.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 57 | 1.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 29 | 3.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 57 | 3.6 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 85 | 62.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 85 | 84.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 180 | 25.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 208 | 89.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 29 | 1.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 365 | 55.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 180 | 34.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 545 | 37.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 85 | 84.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 365 | 73.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 57 | 5.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 545 | 53.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 29 | 3.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 57 | 1.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 85 | 54.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 180 | 41.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 365 | 51.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 180 | 18.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 545 | 42.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 57 | 1.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 29 | 1.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 208 | 93.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 57 | 1.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 85 | 75.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 29 | 3.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 180 | 25.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 208 | 95.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 29 | 1.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 29 | 1.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 365 | 52.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 365 | 38.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 545 | 29.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 365 | 48.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 85 | 87.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 29 | 1.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 365 | 72.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 57 | 3.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 545 | 12.2 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 365 | 70.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 85 | 81.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 180 | 24.6 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 180 | 26.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 208 | 98.1 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 545 | 14.6 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 57 | 3.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 180 | 38.6 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 545 | 36.6 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 545 | 26.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 57 | 3.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 545 | 39.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 29 | 1.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 57 | 7.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 57 | 7.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 29 | 5.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 85 | 92.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 85 | 70.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 180 | 19.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 57 | 1.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 180 | 22.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 85 | 90.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 208 | 94.2 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 208 | 96.2 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 180 | 52.6 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 85 | 70.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 365 | 44.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 208 | 100 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 85 | 6.7 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 57 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 545 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 180 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 29 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 57 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 85 | 3.3 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 180 | 6.7 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 208 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 365 | 3.4 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST1 Day 545 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 29 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 57 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 85 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 180 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 208 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 365 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST2 Day 545 | 3.8 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 29 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 85 | 3.3 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 180 | 3.3 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 208 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 365 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST3 Day 545 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 85 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 29 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 57 | 6.7 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 180 | 6.7 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 208 | 7.7 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 365 | 3.4 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST4 Day 545 | 7.7 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 29 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 57 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 208 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 365 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST5 Day 545 | 3.8 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 29 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 57 | 3.3 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 85 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 180 | 3.3 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 208 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years | ST6 Day 365 | 3.4 Percentage of Participants |
Secondary
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 50 - 65 years. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): \>=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants.
Time frame: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 545 | 14.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 208 | 89.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 545 | 28.6 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 365 | 46.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 85 | 73.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 180 | 16.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 208 | 93.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 365 | 56.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 365 | 63.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 545 | 28.6 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 85 | 60.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 180 | 30.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 208 | 89.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 365 | 56.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 85 | 83.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 545 | 21.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 208 | 89.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 180 | 30.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 545 | 32.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 57 | 3.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 29 | 3.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 57 | 3.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 85 | 83.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 57 | 3.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 180 | 36.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 208 | 96.6 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 29 | 3.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 365 | 73.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 545 | 42.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 85 | 66.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 57 | 3.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 85 | 73.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 180 | 6.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 180 | 26.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 208 | 93.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 365 | 70.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 85 | 79.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 365 | 51.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 57 | 3.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 208 | 92.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 545 | 25.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 208 | 92.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 208 | 96.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 29 | 6.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 365 | 72.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 85 | 65.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 180 | 20.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 365 | 69.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 180 | 37.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 180 | 24.1 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 365 | 37.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 208 | 92.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 545 | 33.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 365 | 58.6 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 365 | 48.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 208 | 96.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 545 | 29.2 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 29 | 3.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 545 | 16.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 57 | 3.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 545 | 33.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 85 | 72.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 85 | 89.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 180 | 24.1 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 180 | 34.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 29 | 6.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 85 | 75.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 208 | 96.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 57 | 6.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 180 | 44.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 57 | 3.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 545 | 33.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 85 | 86.2 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 208 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 29 | 7.7 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 29 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 208 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 85 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 545 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 57 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 85 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 180 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 208 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 365 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST1 Day 545 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 57 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 85 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 180 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 365 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST2 Day 545 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 29 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 57 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 85 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 180 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 365 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST3 Day 545 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 29 | 7.7 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 57 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 85 | 7.7 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 180 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 208 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 365 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST4 Day 545 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 29 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 57 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 180 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 208 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST5 Day 365 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 29 | 7.7 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 57 | 7.7 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 85 | 0.0 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 180 | 7.7 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 208 | 8.3 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 365 | 7.7 Percentage of Participants |
| Placebo | SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years | ST6 Day 545 | 0.0 Percentage of Participants |
Secondary
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
Seroconversion Rate (SCR) for each Outer Surface Protein A (OspA) serotype specific IgG ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18). Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): greater than or equal to (\>=) 4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. Percentages are based on the number of participants with non-missing observations.
Time frame: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 57 | 1.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 208 | 92.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 85 | 73.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 208 | 96.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 180 | 20.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 208 | 94.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 365 | 53.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 365 | 72.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 545 | 34.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 29 | 2.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 85 | 59.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 57 | 3.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 545 | 45.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 85 | 61.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 180 | 27.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 208 | 89.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 365 | 50.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 365 | 56.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 29 | 3.6 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 545 | 31.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 29 | 2.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 545 | 17.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 545 | 39.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 57 | 2.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 85 | 84.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 180 | 40.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 208 | 98.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 29 | 2.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 365 | 70.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 545 | 42.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 180 | 14.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 29 | 1.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 57 | 1.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 57 | 2.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 85 | 74.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 180 | 25.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 85 | 84.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 208 | 97.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 365 | 62.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 57 | 4.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 180 | 32.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 29 | 1.2 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 365 | 38.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 57 | 4.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 57 | 2.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 57 | 1.2 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 85 | 81.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 85 | 69.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 57 | 5.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 180 | 25.6 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 208 | 98.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 85 | 91.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 208 | 96.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 208 | 93.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 545 | 13.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 365 | 48.1 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 29 | 3.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 180 | 50.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 545 | 27.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 365 | 70.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 57 | 3.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 29 | 2.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 85 | 83.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 208 | 97.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 57 | 5.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 180 | 19.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 365 | 51.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 85 | 71.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 29 | 1.2 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 365 | 70.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 180 | 26.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 545 | 35.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 29 | 5.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 208 | 96.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 180 | 24.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 545 | 36.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 365 | 49.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 180 | 38.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 545 | 27.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 545 | 21.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 29 | 1.2 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 208 | 98.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 85 | 89.3 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 85 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 29 | 2.3 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 57 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 85 | 2.3 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 180 | 4.7 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 208 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 365 | 2.4 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST1 Day 545 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 29 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 57 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 85 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 180 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 208 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 365 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST2 Day 545 | 2.6 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 29 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 57 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 85 | 2.3 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 180 | 2.3 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 208 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 365 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST3 Day 545 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 29 | 2.3 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 57 | 4.7 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 85 | 7.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 180 | 4.7 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 208 | 5.3 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 365 | 2.4 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST4 Day 545 | 5.3 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 29 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 57 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 85 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 180 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 208 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 365 | 0.0 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST5 Day 545 | 2.6 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 29 | 2.3 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 57 | 4.7 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 180 | 4.7 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 208 | 2.6 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 365 | 4.8 Percentage of Participants |
| Placebo | SCRs for Each OspA Serotype Specific IgG During the Main Study Phase | ST6 Day 545 | 0.0 Percentage of Participants |
Secondary
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
SCR for each OspA serotype specific IgG ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24, and Month 30. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): greater than or equal to (\>=) 4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. Percentages are based on the number of participants with non-missing observations. The outcome measure was planned to be analyzed for Booster PP population from Day 29 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Time frame: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
Population: Booster PP population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity) and who were enrolled into the booster phase despite exclusion from the PP population of main study phase. Here, Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Day 208 | 97.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Month 30 | 56.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Day 365 | 75.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Day 85 | 89.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Day 57 | 5.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Day 208 | 97.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Day 545 | 35.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Month 19 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Month 24 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Month 30 | 73.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Day 29 | 2.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Day 57 | 2.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Day 57 | 8.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Day 180 | 29.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Day 85 | 64.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Day 365 | 43.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Day 545 | 16.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Month 19 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Month 24 | 89.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Day 29 | 10.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Day 57 | 8.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Day 180 | 59.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Day 85 | 97.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Day 208 | 97.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Day 180 | 48.6 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Day 365 | 73.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Day 545 | 32.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Month 19 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Month 24 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Month 30 | 89.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Day 29 | 2.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Day 85 | 81.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Day 180 | 32.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Day 208 | 97.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Day 365 | 56.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Day 545 | 29.7 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Month 19 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Month 24 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Month 30 | 73.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Day 29 | 8.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Day 57 | 10.8 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Day 85 | 78.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Day 180 | 24.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Day 208 | 97.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Day 365 | 48.6 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Day 545 | 18.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Month 19 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Month 24 | 97.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Month 30 | 81.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Day 29 | 5.4 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Day 57 | 13.5 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Day 85 | 70.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Day 180 | 27.0 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Day 208 | 97.1 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Day 365 | 45.9 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Day 545 | 16.2 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Month 19 | 100 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Month 24 | 97.3 Percentage of Participants |
| VLA15 With Alum Lower Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Month 30 | 73.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Day 85 | 88.2 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Month 19 | 11.1 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Month 30 | 17.6 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Day 180 | 33.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Day 365 | 70.6 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Day 180 | 27.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Day 545 | 27.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Day 365 | 70.6 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Day 85 | 88.2 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Day 545 | 44.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Day 545 | 33.3 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Month 19 | 50.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Day 180 | 44.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Month 24 | 23.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Month 30 | 5.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Month 19 | 16.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Day 365 | 52.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Month 24 | 23.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Day 545 | 38.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Day 85 | 70.6 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Month 24 | 11.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Day 180 | 16.7 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Month 19 | 22.2 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Day 365 | 29.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Month 24 | 17.6 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Day 545 | 11.1 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Month 30 | 11.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST4 Month 30 | 5.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Month 24 | 5.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST1 Month 30 | 5.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Day 85 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Month 19 | 27.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Day 29 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Day 180 | 50.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Day 365 | 76.5 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST2 Day 85 | 88.2 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Day 85 | 94.1 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Day 57 | 0.0 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Day 365 | 70.6 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Day 180 | 38.9 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Day 545 | 44.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST6 Month 30 | 11.8 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Month 19 | 44.4 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST5 Day 208 | 100 Percentage of Participants |
| VLA15 With Alum Higher Dose | SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population | ST3 Month 24 | 29.4 Percentage of Participants |