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| ID | Type | Description | Link |
|---|---|---|---|
| C4601008 | Other Identifier | Alias Study Number |
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| Name | Class |
|---|---|
| Valneva Austria GmbH | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A+B - Group 1 | Experimental | Part A: VLA15 at Month 0, 2 and 6 Part B: VLA15 at Month 18, 30 and 42 |
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| Part A+B - Group 2 | Experimental | Part A: VLA15 at Month 0 and 6, placebo at Month 2 Part B: VLA15 at Month 18, 30 and 42 |
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| Part A+B - Group 3 | Placebo Comparator | Part A: Placebo at Month 0, 2 and 6 Part B: Placebo at Month 18, 30 and 42 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VLA15 | Biological | a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Day 1 to Day 7 after vaccination 1 at Month 0 |
| 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. | From Day 1 to Day 7 after vaccination 2 at Month 2 |
| 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. | From Day 1 to Day 7 after vaccination 3 at Month 6 |
| Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New England Research Associates | Bridgeport | Connecticut | 06606 | United States | ||
| Stamford Therapeutics Consortium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41213278 | Derived | Wagner L, Obersriebnig M, Hochreiter R, Kadlecek V, Larcher-Senn J, Hegele L, Maguire JD, Murphy T, Derhaschnig U, Bezay N, Jaramillo JC, Eder-Lingelbach S, Messier M. Immunogenicity and safety of an 18-month booster dose of the VLA15 Lyme borreliosis vaccine candidate after primary immunisation in children, adolescents, and adults in the USA: a randomised, observer-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2026 Mar;26(3):314-328. doi: 10.1016/S1473-3099(25)00541-9. Epub 2025 Nov 7. | |
| 40294611 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 714 participants were screened of which 89 failed screening and 625 participants were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Group 2: VLA15 + Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2024 | Oct 31, 2024 |
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| Placebo | Biological | PBS (Phosphate Buffered Saline) |
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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. |
| From Day 1 to Day 7 after vaccination 1, 2 or 3 at Month 0, 2 and 6 respectively |
| 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. | Day 208 (Month 7) |
| Within 7 days after booster dose |
| 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. | From Day 1 of vaccination up to Day 208 (Month 7) |
| 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. | From Day 1 of vaccination up to Day 208 (Month 7) |
| 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. | From Day 1 to Day 28 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively |
| 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. | 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 |
| 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. | Baseline, Day 85, Day 180 and Day 194 |
| 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. | Day 85, Day 180, Day 194 and Day 208 |
| 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. | Baseline, Day 85 and 208 |
| 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). | Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208 |
| 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. | Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208 |
| 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. | Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208 |
| GMTs for IgG Against Each OspA Serotype (ST1 to ST6) During the Booster Phase | Up to Month 48 |
| 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. | Up to Month 48 |
| GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Month 19 During the Booster Phase | Month 19 |
| GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase | Up to Month 48 |
| 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. | Up to Month 48 |
| GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase | Up to Month 48 |
| Stamford |
| Connecticut |
| 06905 |
| United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| Pediatric Associates of Conn. PC | Waterbury | Connecticut | 06708 | United States |
| Clinical Research Institute, Inc. | Minneapolis | Minnesota | 55402 | United States |
| Foundation Pediatrics | East Orange | New Jersey | 07018 | United States |
| Med Clinical Research Partners, LLC | Irvington | New Jersey | 07111 | United States |
| Meridian Clinical Research LLC | Binghamton | New York | 13905 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | United States |
| Advantage Clinical Trials | The Bronx | New York | 10467 | United States |
| Velocity Clinical Research, Inc. | Cleveland | Ohio | 44122 | United States |
| Allegheny Health and Wellness Pavilion | Erie | Pennsylvania | 16506 | United States |
| Liberty Family Practice | Erie | Pennsylvania | 16508 | United States |
| Lockman & Lubell Pediatric Associates | Fort Washington | Pennsylvania | 19034 | United States |
| Hasbro Children's Hospital | Providence | Rhode Island | 02903 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Velocity Clinical Research Providence | Warwick | Rhode Island | 02886 | United States |
| Derived |
| Wagner L, Obersriebnig M, Kadlecek V, Hochreiter R, Ghadge SK, Larcher-Senn J, Hegele L, Maguire JD, Derhaschnig U, Jaramillo JC, Eder-Lingelbach S, Bezay N. Immunogenicity and safety of different immunisation schedules of the VLA15 Lyme borreliosis vaccine candidate in adults, adolescents, and children: a randomised, observer-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2025 Sep;25(9):986-999. doi: 10.1016/S1473-3099(25)00092-1. Epub 2025 Apr 25. |
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. |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set included all participants enrolled who received at least one vaccination. Participants were analyzed according to the study group they were allocated to, rather than by the actual treatment they received.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 to Day 7 after vaccination 1 at Month 0 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 to Day 7 after vaccination 2 at Month 2 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 to Day 7 after vaccination 3 at Month 6 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 to Day 7 after vaccination 1, 2 or 3 at Month 0, 2 and 6 respectively |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Units per milliliter | Day 208 (Month 7) |
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| 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. | Not Posted | Jan 2027 | Within 7 days after booster dose | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 of vaccination up to Day 208 (Month 7) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 of vaccination up to Day 208 (Month 7) |
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| 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. | Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 to Day 28 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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 |
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| 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. | Not Posted | Jan 2027 | Baseline, Day 85, Day 180 and Day 194 | Participants | |||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | Jan 2027 | Day 85, Day 180, Day 194 and Day 208 | 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. | Not Posted | Jan 2027 | Baseline, Day 85 and 208 | Participants | |||||||||||||||||||||||||||||||||||||
| 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). | Not Posted | Jan 2027 | Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208 | Participants | |||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | Jan 2027 | Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208 | Participants | |||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | Jan 2027 | Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208 | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) During the Booster Phase | Not Posted | Jan 2027 | Up to Month 48 | 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. | Not Posted | Jan 2027 | Up to Month 48 | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Month 19 During the Booster Phase | Not Posted | Jan 2027 | Month 19 | Participants | ||||||||||||||||||||||||||||||||||||||
| Secondary | GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase | Not Posted | Jan 2027 | Up to Month 48 | Participants | ||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | Jan 2027 | Up to Month 48 | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase | Not Posted | Jan 2027 | Up to Month 48 | Participants |
Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema [redness]), induration [hardening], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 190 | 0 | 190 | 178 | 190 |
| EG001 | 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. | 0 | 187 | 2 | 187 | 179 | 187 |
| EG002 | 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. | 0 | 208 | 4 | 208 | 133 | 208 |
| EG003 | Any VLA15 | Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2. | 0 | 417 | 3 | 417 | 391 | 417 |
| EG004 | All Participants | Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination. | 0 | 625 | 7 | 625 | 524 | 625 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major depression | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Reactive attachment disorder of infancy or early childhood | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
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| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | 0 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2022 | Mar 24, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008193 | Lyme Disease |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| Unknown or Not Reported |
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| Tenderness |
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| Erythema/redness |
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| Swelling |
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| Induration/Hardening |
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| Headache |
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| Muscle pain |
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| Joint pain |
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| Nausea |
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| Vomiting |
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| Fatigue |
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| Fever |
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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.
| OG002 | 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. |
| OG003 | Any VLA15 | Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2. |
| OG004 | All Participants | Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination. |
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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.
| OG002 | 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. |
| OG003 | Any VLA15 | Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2. |
| OG004 | All Participants | Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination. |
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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.
| OG002 | 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. |
| OG003 | Any VLA15 | Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2. |
| OG004 | All Participants | Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination. |
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| OG002 | 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. |
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| OG002 |
| 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. |
| OG003 | Any VLA15 | Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2. |
| OG004 | All Participants | Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination. |
|
|
| 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. |
| OG003 | Any VLA15 | Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2. |
| OG004 | All Participants | Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination. |
|
|
| 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. |
| OG003 | Any VLA15 | Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2. |
| OG004 | All Participants | Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination. |
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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. |
| OG001 | 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. |
| OG002 | 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. |
| OG003 | Any VLA15 | Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2. |
| OG004 | All Participants | Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination. |
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