Lyme Borreliosis
Conditions
Keywords
VLA15, Lyme Borreliosis, Vaccine, Lyme disease, Borrelia
Brief summary
VLA15-221 is a Phase 2 study, which will be conducted in two parts: Main Study Phase (Part A) and Booster Phase (Part B). The study will compare the safety and immunogenicity of two different primary immunization schedules applying three (Month 0-2-6) or two (Month 0- 6) vaccinations. Within the study, 600 healthy subjects aged 5-65 years will be included. Subjects with a history of Lyme borreliosis (previous infection with Borrelia) as well as Borrelia naïve subjects will be enrolled. Study duration per subject will be a maximum of 50 months per subject.
Detailed description
VLA15-221 is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study, which is set up in two parts: Main Study Phase (Part A) and Booster Phase (Part B). In Part A 600 subjects aged 5-65 years will be enrolled 1:1:1 into three groups: Group 1 will be vaccinated with VLA15 at Month 0-2-6, Group 2 will be vaccinated with VLA15 at Month 0-6 and with placebo at Month 2 and Group 3 will be vaccinated with placebo at Month 0-2-6. In Part B all eligible subjects will receive booster injections with VLA15 or placebo at Month 18, 30 and 42.
Interventions
BIOLOGICALVLA15
a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate
BIOLOGICALPlacebo
PBS (Phosphate Buffered Saline)
Sponsors
Pfizer
Valneva Austria GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is aged 5 to 65 years at the day of screening (Visit 0) * Subject is of good general health * Parent(s)/legal representative(s) and subject understand the study and its procedures, agree to its provisions * for subjects aged 18-65 years: written informed consent prior to any study related procedures * for subjects aged 5-17 years: written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable, prior to any study related procedures. * If subject is of childbearing potential: Subject has a negative serum pregnancy test at screening (Visit 0) and agrees to employ adequate birth control measures according to following timelines: * Main Study Phase: duration of entire study * Booster Phase: until 5 months after each booster vaccination (Booster 1 until Month 23, Booster 2 until Month 35 and Booster 3 until Month 47) * Subject is willing and able to comply with scheduled visits, treatment plan, and other study procedures * Subject is available for the duration of the study and can be contacted by telephone during study participation
Exclusion criteria
* Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB, or received treatment for LB within the last 3 months prior to Day 1; * Subject received previous vaccination against LB; * Subject had a tick bite within 4 weeks prior to Day 1; * Subject has a medical history of or currently has a clinically relevant disease; * Subject has a medical history of or currently has a neuro- inflammatory or autoimmune disease; * Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the 3 weeks prior to Day 1; * Subject has received an active or passive immunization within 4 weeks prior to Day 1; * Subject has received any other registered or non-registered medicinal product in another clinical trial within 4 weeks prior to vaccination at Day 1; * Subject has a known or suspected defect of the immune system or received immuno-suppressive therapy within 4 weeks prior to Day 1; * Subject has a history of anaphylaxis of unknown cause or severe allergic reactions of unknown cause or has a known hypersensitivity or allergic reactions to one of the components of the vaccine; * Subject had any malignancy in the past 5 years; * Subject is pregnant, has plans to become pregnant during the course of the study or is lactating at the time of enrollment; * Subject has donated or plans to donate blood or blood-derived products 4 weeks prior to Day 1; * Subject has any condition that may compromise its well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study; * Subject is in a dependent relationship with the sponsor/investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | From Day 1 to Day 7 after vaccination 1 at Month 0 | Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness meeting grading scale (MGS), swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. |
| Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | From Day 1 to Day 7 after vaccination 2 at Month 2 | Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. |
| Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | From Day 1 to Day 7 after vaccination 3 at Month 6 | Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. |
| Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | From Day 1 to Day 7 after any vaccination 1, 2 or 3 at Month 0, 2 and 6, respectively | Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. |
| Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | At Day 208 (Month 7) | GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay at Day 208 was presented in this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 1 Booster Dose | From Day 1 to Day 7 after vaccination 1 booster dose at Month 18 | Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. |
| Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 Booster Dose | From Day 1 to Day 7 after vaccination 2 booster dose at Month 30 | Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. |
| Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 Booster Dose | From Day 1 to Day 7 after vaccination 3 booster dose at Month 42 | Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. |
| Percentage of Participants With Serious Adverse Events (SAEs) | From Day 1 of vaccination 1 up to 6 months following the last booster dose (up to Month 48) | A SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. |
| Percentage of Participants With Adverse Events of Special Interest (AESIs) | From Day 1 of vaccination 1 up to 6 months following the last booster dose (up to Month 48) | An AESI (serious or non-serious) was one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor were appropriate. |
| Percentage of Participants With Unsolicited AE | Up to 28 Days after vaccination 1, 2 or 3 at Month 0, 2 and 6, respectively, and up to 28 Days after vaccination 1, 2 or 3 booster dose at Month 18, 30 and 42, respectively | An AE was any untoward medical occurrence in a participant administered an investigational product, whether or not related to this treatment. Unsolicited AEs were defined as any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event. |
| Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | SAEs & AESIs: From Day 1 of vaccination up to Month 48; Solicited AEs: from Day 1 to Day 7 after vaccination 1, 2, 3, 4, 5 and 6; Unsolicited AEs: up to 28 Days after vaccination 1, 2, 3, 4, 5 and 6 | Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs stratified by age group 5-11, 12-17 and 18-65 years were reported. SAE: any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. AESI: scientific and medical concern specific to the sponsor's product or program. Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AEs: any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event. |
| GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Baseline, Days 85, 180, 365 and Month 18 | Baseline; Days 85, 180 and 365; Month 18 | GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay were evaluated. |
| Seroconversion Rate (SCR) at Days 85, 180, 208, 365 and Month 18 | Days 85, 180, 208 and 365; Month 18 | Seroconversion for enzyme linked immunosorbent assay (ELISA) was defined as a change from seronegative at baseline to seropositive at a measured time point. For participants who were OspA seropositive at baseline, seroconversion was defined as a greater than or equal to (\>=) 4-fold rise in IgG antibody titer from baseline. SCR was percentage of participants with seroconversion reported for each OspA serotype specific IgG ST1 to ST6, as determined by ELISA. |
| Geometric Mean of the Fold Rise (GMFR) for IgG When Compared to Baseline Against Each OspA Serotype (ST1 to ST6) at Days 85 and 208 | Days 85 and 208 | GMFR for IgG when compared to baseline against each OspA serotype ST1 to ST6, determined by IgG binding assay at Day 85 and Day 208 were evaluated. |
| GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Baseline, Days 85, 180, 194, 365 and Month 18 | Baseline; Days 85, 180, 194 (18 to 65 years only) and 365; Month 18 | GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (5-11, 12-17 and 18-65 years) were evaluated. Day 194 data was reported for adult participants only as pre-specified in protocol. |
| SCR Stratified by Age Group at Days 85, 180, 194, 208, 365 and Month 18 | Days 85, 180, 194 (18 to 65 years only), 208 and 365; Month 18 | Seroconversion for ELISA was defined as a change from seronegative at baseline to seropositive at a measured time point. For participants who were OspA seropositive at baseline, seroconversion was defined as a \>=4-fold rise in IgG antibody titer from baseline. SCR was percentage of participants with seroconversion reported for each OspA serotype specific IgG ST1 to ST6, as determined by ELISA. Day 194 data was reported for adult participants only as pre-specified in protocol. |
| GMFR for IgG When Compared to Baseline Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Days 85 and 208 | Days 85 and 208 | GMFR for IgG when compared to baseline against each OspA serotype ST1 to ST6, stratified by age group (5-11, 12-17 and 18-65 years) determined by IgG binding assay at Day 85 and Day 208 were evaluated. |
| GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48 | Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48 | GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay were evaluated. |
| SCR at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48 | Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48 | Seroconversion for ELISA was defined as a change from seronegative at baseline to seropositive at a measured time point. For participants who were OspA seropositive at baseline, seroconversion was defined as a \>=4-fold rise in IgG antibody titer from baseline. SCR was percentage of participants with seroconversion reported for each OspA serotype specific IgG ST1 to ST6, as determined by ELISA. |
| GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Months 19, 31 and 43 During the Booster Phase | Months 19, 31 and 43 | GMFRs for IgG were determined by IgG binding assay for each OspA serotype (ST1-ST6) at Months 19, 31, and 43 relative to the corresponding pre-booster timepoints Months 18, 30, and 42, respectively. |
| GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48 | Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48 | GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (5-11, 12-17 and 18-65 years) were evaluated. |
| SCR Stratified by Age Group at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48 | Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48 | Seroconversion for ELISA was defined as a change from seronegative at baseline to seropositive at a measured time point. For participants who were OspA seropositive at baseline, seroconversion was defined as a \>=4-fold rise in IgG antibody titer from baseline. SCR was percentage of participants with seroconversion reported for each OspA serotype specific IgG ST1 to ST6, as determined by ELISA. |
| GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Months 19, 31 and 43 During the Booster Phase | Months 19, 31 and 43 | GMFRs for IgG were determined by IgG binding assay for each OspA serotype (ST1-ST6), stratified by age group (5-11, 12-17 and 18-65 years) at Months 19, 31, and 43 relative to the corresponding pre-booster timepoints Months 18, 30, and 42, respectively. |
Countries
United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: VLA15 Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase. | 208 |
| Group 2: VLA15 + Placebo Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase. | 209 |
| Group 3: Placebo Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase. | 208 |
| Total | 625 |
Baseline characteristics
| Characteristic | Group 1: VLA15 | Group 2: VLA15 + Placebo | Group 3: Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 28.7 Years STANDARD_DEVIATION 19.09 | 28.9 Years STANDARD_DEVIATION 19.56 | 29.0 Years STANDARD_DEVIATION 19.72 | 28.9 Years STANDARD_DEVIATION 19.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 15 Participants | 18 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 185 Participants | 194 Participants | 190 Participants | 569 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 3 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 17 Participants | 24 Participants | 68 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 2 Participants | 11 Participants |
| Race (NIH/OMB) White | 172 Participants | 184 Participants | 176 Participants | 532 Participants |
| Sex: Female, Male Female | 112 Participants | 108 Participants | 101 Participants | 321 Participants |
| Sex: Female, Male Male | 96 Participants | 101 Participants | 107 Participants | 304 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 / 127 | 0 / 112 | 0 / 206 | 1 / 419 | 1 / 625 |
| other Total, other adverse events | 124 / 127 | 111 / 112 | 145 / 206 | 403 / 419 | 548 / 625 |
| serious Total, serious adverse events | 0 / 127 | 4 / 112 | 14 / 206 | 14 / 419 | 28 / 625 |
Outcome results
Primary
Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay at Day 208 is presented in this outcome measure.
Time frame: Day 208 (Month 7)
Population: Per-Protocol Analysis Set (PPAS) consisted of the FAS population excluding those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, Number Analyzed signifies participants with available results for each serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: VLA15 | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | ST1 | 333.2 Units per milliliter |
| Group 1: VLA15 | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | ST2 | 656.0 Units per milliliter |
| Group 1: VLA15 | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | ST3 | 586.4 Units per milliliter |
| Group 1: VLA15 | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | ST4 | 422.8 Units per milliliter |
| Group 1: VLA15 | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | ST5 | 443.4 Units per milliliter |
| Group 1: VLA15 | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | ST6 | 429.7 Units per milliliter |
| Group 2: VLA15 + Placebo | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | ST6 | 222.0 Units per milliliter |
| Group 2: VLA15 + Placebo | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | ST1 | 197.3 Units per milliliter |
| Group 2: VLA15 + Placebo | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | ST4 | 245.8 Units per milliliter |
| Group 2: VLA15 + Placebo | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | ST5 | 239.4 Units per milliliter |
| Group 2: VLA15 + Placebo | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | ST2 | 460.3 Units per milliliter |
| Group 2: VLA15 + Placebo | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | ST3 | 436.2 Units per milliliter |
| Group 3: Placebo | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | ST2 | 21.9 Units per milliliter |
| Group 3: Placebo | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | ST3 | 21.9 Units per milliliter |
| Group 3: Placebo | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | ST6 | 24.3 Units per milliliter |
| Group 3: Placebo | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | ST4 | 23.5 Units per milliliter |
| Group 3: Placebo | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | ST1 | 23.8 Units per milliliter |
| Group 3: Placebo | Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase | ST5 | 22.4 Units per milliliter |
Primary
Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day 1 to Day 7 after vaccination 1 at Month 0
Population: Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, Number Analyzed signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Joint pain | 9.9 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Fatigue | 20.7 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Pain | 63.0 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Swelling | 8.9 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Headache | 24.9 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Fever | 1.8 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Vomiting | 1.1 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Erythema/redness | 12.2 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Induration/Hardening | 10.0 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Muscle pain | 36.1 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Tenderness | 81.6 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Nausea | 3.9 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Fever | 0.0 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Headache | 21.1 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Tenderness | 84.8 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Muscle pain | 34.6 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Pain | 59.3 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Fatigue | 17.1 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Erythema/redness | 14.9 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Joint pain | 3.9 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Vomiting | 0.6 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Swelling | 8.8 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Nausea | 6.1 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Induration/Hardening | 6.6 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Fatigue | 16.4 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Pain | 12.5 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Tenderness | 19.5 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Erythema/redness | 2.5 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Swelling | 0.5 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Induration/Hardening | 1.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Headache | 19.5 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Muscle pain | 11.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Joint pain | 6.5 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Nausea | 6.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Vomiting | 1.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Fever | 0.5 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Headache | 23.5 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Pain | 60.4 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Joint pain | 7.6 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Induration/Hardening | 8.9 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Nausea | 5.4 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Swelling | 9.1 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Fever | 1.1 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Vomiting | 0.8 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Erythema/redness | 13.1 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Tenderness | 81.8 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Fatigue | 19.7 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Muscle pain | 35.7 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Headache | 22.1 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Vomiting | 0.8 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Pain | 44.5 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Joint pain | 7.2 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Tenderness | 61.2 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Swelling | 6.2 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Fever | 0.9 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Induration/Hardening | 6.2 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Nausea | 5.6 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Muscle pain | 27.5 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Erythema/redness | 9.6 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 | Fatigue | 18.6 Percentage of participants |
Primary
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day 1 to Day 7 after vaccination 1, 2 or 3 at Month 0, 2 and 6 respectively
Population: Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table and for each specified row.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Fever | 3.2 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Erythema/Redness | 26.8 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Induration/Hardening | 19.5 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Joint pain | 15.3 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Vomiting | 3.2 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Swelling | 20.5 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Tenderness | 92.6 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Muscle pain | 45.8 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Nausea | 8.4 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Fatigue | 33.2 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Headache | 38.4 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Pain | 80.5 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Swelling | 16.6 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Vomiting | 3.2 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Headache | 36.4 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Fatigue | 29.9 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Induration/Hardening | 14.4 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Erythema/Redness | 18.7 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Muscle pain | 48.1 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Fever | 1.6 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Tenderness | 92.5 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Joint pain | 9.6 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Pain | 77.0 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Nausea | 11.2 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Erythema/Redness | 3.4 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Induration/Hardening | 1.4 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Headache | 28.8 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Muscle pain | 17.8 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Joint pain | 8.2 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Nausea | 9.6 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Vomiting | 1.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Fatigue | 28.4 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Fever | 1.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Pain | 16.8 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Tenderness | 28.4 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Swelling | 1.4 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Vomiting | 2.9 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Induration/Hardening | 16.5 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Fever | 2.4 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Nausea | 9.6 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Pain | 77.0 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Joint pain | 13.2 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Swelling | 18.0 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Tenderness | 90.6 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Muscle pain | 46.8 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Headache | 37.4 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Erythema/Redness | 21.8 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Fatigue | 31.4 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Vomiting | 2.2 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Tenderness | 69.9 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Induration/Hardening | 11.5 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Fever | 1.9 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Headache | 34.6 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Joint pain | 11.5 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Swelling | 12.5 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Nausea | 9.6 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Pain | 57.0 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Fatigue | 30.4 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Muscle pain | 37.1 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase | Erythema/Redness | 15.7 Percentage of participants |
Primary
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day 1 to Day 7 after vaccination 2 at Month 2
Population: Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, Number Analyzed signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Muscle pain | 23.8 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Pain | 56.8 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Fatigue | 13.6 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Joint pain | 4.9 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Swelling | 11.4 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Tenderness | 81.4 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Nausea | 4.3 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Vomiting | 1.1 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Headache | 16.8 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Induration/Hardening | 9.2 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Erythema/redness | 15.8 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Fever | 1.7 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Erythema/redness | 0.0 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Headache | 12.5 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Muscle pain | 4.0 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Tenderness | 14.7 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Pain | 7.9 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Fatigue | 9.1 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Joint pain | 3.4 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Vomiting | 1.7 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Swelling | 0.0 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Fever | 0.0 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Nausea | 3.4 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Induration/Hardening | 1.1 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Fatigue | 12.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Pain | 8.4 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Tenderness | 14.5 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Erythema/redness | 1.6 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Swelling | 0.5 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Induration/Hardening | 0.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Headache | 13.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Muscle pain | 3.7 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Joint pain | 1.6 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Nausea | 5.7 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Vomiting | 0.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Fever | 0.0 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Vomiting | 1.3 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Joint pain | 4.7 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Erythema/redness | 7.5 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Nausea | 3.6 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Tenderness | 47.6 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Fatigue | 11.9 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Induration/Hardening | 5.4 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Swelling | 5.4 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Headache | 15.3 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Pain | 32.1 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Muscle pain | 14.2 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Fever | 0.8 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Muscle pain | 10.7 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Joint pain | 3.6 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Swelling | 3.8 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Fever | 0.5 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Nausea | 4.3 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Erythema/redness | 5.5 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Vomiting | 0.9 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Tenderness | 36.7 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Fatigue | 12.0 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Headache | 14.5 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Pain | 24.3 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 | Induration/Hardening | 3.6 Percentage of participants |
Primary
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day 1 to Day 7 after vaccination 3 at Month 6
Population: Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, Number Analyzed signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Joint pain | 6.3 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Fatigue | 17.7 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Pain | 57.3 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Swelling | 7.9 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Headache | 16.6 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Fever | 0.0 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Vomiting | 1.1 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Erythema/redness | 10.7 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Induration/Hardening | 7.9 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Muscle pain | 26.7 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Tenderness | 74.3 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Nausea | 2.3 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Fever | 1.8 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Headache | 20.8 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Tenderness | 83.2 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Muscle pain | 29.6 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Pain | 62.4 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Fatigue | 16.9 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Erythema/redness | 7.9 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Joint pain | 3.9 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Vomiting | 1.1 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Swelling | 10.2 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Nausea | 4.0 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Induration/Hardening | 9.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Fatigue | 11.7 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Pain | 5.6 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Tenderness | 12.8 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Erythema/redness | 1.1 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Swelling | 0.6 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Induration/Hardening | 0.6 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Headache | 8.9 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Muscle pain | 7.8 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Joint pain | 3.3 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Nausea | 2.2 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Vomiting | 0.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Fever | 0.6 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Headache | 18.6 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Pain | 59.5 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Joint pain | 5.0 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Induration/Hardening | 8.3 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Nausea | 3.1 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Swelling | 9.1 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Fever | 0.9 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Vomiting | 1.1 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Erythema/redness | 9.7 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Tenderness | 78.6 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Fatigue | 17.2 Percentage of participants |
| Any VLA15 | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Muscle pain | 28.2 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Headache | 15.4 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Vomiting | 0.7 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Pain | 41.7 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Joint pain | 4.4 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Tenderness | 57.0 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Swelling | 6.3 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Fever | 0.8 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Induration/Hardening | 5.7 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Nausea | 2.8 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Muscle pain | 21.4 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Erythema/redness | 6.8 Percentage of participants |
| All Participants | Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 | Fatigue | 15.4 Percentage of participants |
Secondary
Geometric Mean of the Fold Rise (GMFR) for IgG Against Each OspA Serotype (ST1 to ST6) at Day 85 and Day 208 During the Main Study Phase
GMFR as compared to baseline for IgG against each OspA serotype ST1 to ST6, determined by IgG binding assay at Day 85 and Day 208.
Time frame: Baseline, Day 85 and 208
Secondary
Geometric Mean of the Fold Rise (GMFR) for IgG Against Each OspA Serotype (ST1 to ST6) at Day 85, Day 180, Day 194 and Day 208 Stratified by Age Group During the Main Study Phase
GMFR as compared to baseline for IgG against each OspA serotype ST1 to ST6, stratified by age group (18 to 65, 12 to 17 and 5 to 11 years) determined by IgG binding assay at Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208.
Time frame: Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208
Secondary
GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Month 19 During the Booster Phase
Time frame: Month 19
Secondary
GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase
Time frame: Up to Month 48
Secondary
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Baseline, Day 85, Day 180 and Day 194 During the Main Study Phase
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay.
Time frame: Baseline, Day 85, Day 180 and Day 194
Secondary
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) During the Booster Phase
Time frame: Up to Month 48
Secondary
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase
Time frame: Up to Month 48
Secondary
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Baseline, Day 85, Day 180, Day 194 and Day 208 During the Main Study Phase
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (18 to 65, 12 to 17 and 5 to 11 years).
Time frame: Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208
Secondary
Percentage of Participants With Adverse Events of Special Interest (AESIs)
An AESI (serious or non-serious) was one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor were appropriate. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day 1 of vaccination up to Day 208 (Month 7)
Population: Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: VLA15 | Percentage of Participants With Adverse Events of Special Interest (AESIs) | 0.0 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Adverse Events of Special Interest (AESIs) | 0.5 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Adverse Events of Special Interest (AESIs) | 0.0 Percentage of participants |
| Any VLA15 | Percentage of Participants With Adverse Events of Special Interest (AESIs) | 1.2 Percentage of participants |
| All Participants | Percentage of Participants With Adverse Events of Special Interest (AESIs) | 0.8 Percentage of participants |
Secondary
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs stratified by age group 18 to 65, 12 to 17 and 5 to 11 years were reported. SAE: any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. AESI: scientific and medical concern specific to the sponsor's product or program. Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AEs: any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event. Unsolicited AEs were collected only up to 28 days after any vaccination. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: SAEs, AESIs: From Day 1 of vaccination (vac) up to Day 208 (Month 7), Solicited AEs: From Day 1 to Day 7 after vac 1, 2 and 3 at Month 0, 2 and 6, respectively; Unsolicited AEs: From Day 1 to Day 28 after vac 1, 2 and 3 at Month 0, 2 and 6, respectively
Population: Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, Number Analyzed signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Solicited AE: 12 to 17 years | 97.7 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Unsolicited AE: 12 to 17 years | 18.2 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | SAE: 18 to 65 years | 0.0 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | AESI: 18 to 65 years | 0.0 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | AESI: 5 to 11 years | 0.0 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Unsolicited AE: 5 to 11 years | 2.0 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Unsolicited AE: 18 to 65 years | 23.7 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | SAE: 5 to 11 years | 0.0 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | AESI: 12 to 17 years | 0.0 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Solicited AE: 18 to 65 years | 94.8 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | SAE: 12 to 17 years | 0.0 Percentage of participants |
| Group 1: VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Solicited AE: 5 to 11 years | 87.8 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Unsolicited AE: 5 to 11 years | 20.4 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | AESI: 5 to 11 years | 2.0 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | SAE: 12 to 17 years | 0.0 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Solicited AE: 18 to 65 years | 95.6 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | SAE: 18 to 65 years | 1.1 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Unsolicited AE: 12 to 17 years | 20.8 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | SAE: 5 to 11 years | 2.0 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Solicited AE: 12 to 17 years | 93.8 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Unsolicited AE: 18 to 65 years | 30.0 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | AESI: 18 to 65 years | 0.0 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Solicited AE: 5 to 11 years | 98.0 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | AESI: 12 to 17 years | 0.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Unsolicited AE: 12 to 17 years | 22.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | SAE: 18 to 65 years | 1.9 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | SAE: 12 to 17 years | 4.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | SAE: 5 to 11 years | 0.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | AESI: 18 to 65 years | 0.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | AESI: 12 to 17 years | 0.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | AESI: 5 to 11 years | 0.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Solicited AE: 18 to 65 years | 62.6 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Solicited AE: 12 to 17 years | 60.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Solicited AE: 5 to 11 years | 64.7 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Unsolicited AE: 18 to 65 years | 29.0 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Unsolicited AE: 5 to 11 years | 17.6 Percentage of participants |
| Any VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | AESI: 5 to 11 years | 1.9 Percentage of participants |
| Any VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | SAE: 18 to 65 years | 0.5 Percentage of participants |
| Any VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Solicited AE: 12 to 17 years | 95.0 Percentage of participants |
| Any VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | AESI: 12 to 17 years | 1.0 Percentage of participants |
| Any VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Solicited AE: 5 to 11 years | 93.3 Percentage of participants |
| Any VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | AESI: 18 to 65 years | 0.9 Percentage of participants |
| Any VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Unsolicited AE: 5 to 11 years | 11.5 Percentage of participants |
| Any VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Unsolicited AE: 18 to 65 years | 26.3 Percentage of participants |
| Any VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | SAE: 5 to 11 years | 1.0 Percentage of participants |
| Any VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | SAE: 12 to 17 years | 1.0 Percentage of participants |
| Any VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Unsolicited AE: 12 to 17 years | 19.0 Percentage of participants |
| Any VLA15 | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Solicited AE: 18 to 65 years | 93.9 Percentage of participants |
| All Participants | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | AESI: 5 to 11 years | 1.3 Percentage of participants |
| All Participants | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Unsolicited AE: 18 to 65 years | 27.2 Percentage of participants |
| All Participants | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | SAE: 18 to 65 years | 0.9 Percentage of participants |
| All Participants | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Solicited AE: 12 to 17 years | 83.3 Percentage of participants |
| All Participants | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | SAE: 12 to 17 years | 2.0 Percentage of participants |
| All Participants | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | AESI: 18 to 65 years | 0.6 Percentage of participants |
| All Participants | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Unsolicited AE: 5 to 11 years | 13.5 Percentage of participants |
| All Participants | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | AESI: 12 to 17 years | 0.7 Percentage of participants |
| All Participants | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Solicited AE: 5 to 11 years | 83.9 Percentage of participants |
| All Participants | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Solicited AE: 18 to 65 years | 83.4 Percentage of participants |
| All Participants | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | SAE: 5 to 11 years | 0.6 Percentage of participants |
| All Participants | Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group | Unsolicited AE: 12 to 17 years | 20.0 Percentage of participants |
Secondary
Percentage of Participants With Serious Adverse Events (SAEs)
SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day 1 of vaccination up to Day 208 (Month 7)
Population: Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: VLA15 | Percentage of Participants With Serious Adverse Events (SAEs) | 0.0 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Serious Adverse Events (SAEs) | 1.1 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Serious Adverse Events (SAEs) | 1.9 Percentage of participants |
| Any VLA15 | Percentage of Participants With Serious Adverse Events (SAEs) | 0.7 Percentage of participants |
| All Participants | Percentage of Participants With Serious Adverse Events (SAEs) | 1.1 Percentage of participants |
Secondary
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Dose
Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
Time frame: Within 7 days after booster dose
Secondary
Percentage of Participants With Unsolicited Adverse Events
An AE was any untoward medical occurrence in a participant administered an investigational product, whether or not related to this treatment. Unsolicited AEs were defined as any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event. Two-sided 95% confidence intervals were calculated according to Altman method.
Time frame: From Day 1 to Day 28 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively
Population: Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: VLA15 | Percentage of Participants With Unsolicited Adverse Events | 16.8 Percentage of participants |
| Group 2: VLA15 + Placebo | Percentage of Participants With Unsolicited Adverse Events | 25.1 Percentage of participants |
| Group 3: Placebo | Percentage of Participants With Unsolicited Adverse Events | 24.5 Percentage of participants |
| Any VLA15 | Percentage of Participants With Unsolicited Adverse Events | 20.9 Percentage of participants |
| All Participants | Percentage of Participants With Unsolicited Adverse Events | 22.1 Percentage of participants |
Secondary
SCR for Each OspA Serotype (ST1 to ST6) IgG During the Booster Phase
Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: a change from seronegative at screening to seropositive (i.e. antibody titer of \>=40 U/mL) at a certain time point. 2) For participants who were seropositive at screening: a \>= 4-fold rise in OspA IgG antibody titer from screening.
Time frame: Up to Month 48
Secondary
SCR for Each OspA Serotype (ST1 to ST6) IgG Stratified by Age Cohort During the Booster Phase
Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: a change from seronegative at screening to seropositive (i.e. antibody titer of \>=40 U/mL) at a certain time point. 2) For participants who were seropositive at screening: a \>= 4-fold rise in OspA IgG antibody titer from screening.
Time frame: Up to Month 48
Secondary
Seroconversion Rate for Each OspA Serotype (ST1 to ST6) Specific IgG at Day 85, 180, 194 and 208
Seroconversion Rate (SCR) for each OspA serotype specific IgG ST1 to ST6, determined by enzyme linked immunosorbent assay (ELISA). Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: percentage of participants with a change from seronegative at screening to seropositive (i.e. antibody titer of \>=40 Units per milliliter \[U/mL\]) at a certain time point. 2) For participants who were seropositive at screening: percentage of participants with a \>= 4-fold rise in OspA IgG antibody titer from screening.
Time frame: Day 85, Day 180, Day 194 and Day 208
Secondary
Seroconversion Rate for Each OspA Serotype (ST1 to ST6) Specific IgG at Day 85, 180, 194 and 208 Stratified by Age Group During the Main Study Phase
SCR for each OspA serotype specific IgG ST1 to ST6, determined by ELISA stratified by age group (18 to 65, 12 to 17 and 5 to 11 years). Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: percentage of participants with a change from seronegative at screening to seropositive (i.e. antibody titer of \>=40 Units per milliliter \[U/mL\]) at a certain time point. 2) For participants who were seropositive at screening: percentage of participants with a \>= 4-fold rise in OspA IgG antibody titer from screening.
Time frame: Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208