Approval Probability
TA Base Rate
Adjusted LOA
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Also known as PF-07307405
VLA15 · 8 trials · 3 indications
Objective to determine non-inferiority of Dose 5 compared to Dose 4 in all participants when there is a 1 year gap between Dose 4 and Dose 5.
Difference in seroresponse rate between 1 month after Dose 5 and 1 month after Dose 4 for each serotype in all participants ≥7 years of age who received a fifth dose of VLA15 1 year after their fourth dose of VLA15.
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 1 were included in this outcome measure. AEs included both serious AEs (SAEs) and non-SAEs.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 2 were included in this outcome measure. AEs included both SAEs and non-SAEs.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 3 were included in this outcome measure. AEs included both SAEs and non-SAEs.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 4 were included in this outcome measure. AEs included both SAEs and non-SAEs.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after any dose were included in this outcome measure.
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. NDCMCs included conditions that were undiagnosed prior to study entry (diagnosed while in the study and confirmed not to be a preexisting condition) and that were not considered temporary conditions based upon the expected natural history of the condition. An NDCMC was not reported on AE CRF.
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other important medical event.
A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the independent Adjudication Committee
Immunobridging objective to determine non-inferiority between 5-17 year old and 18-44 year old participant strata using GMRs 1 month after completion of booster dose.
Immunobridging objective to determine non-inferiority between 5-17 year old and 18-44 year old participant strata using difference in seroresponse rates 1 month after completion of booster dose.
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.
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.
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.
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.
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.
Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) against each Outer Surface Protein A (OspA) serotype ST1 to ST6, determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 208 (Month 7)
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype ST1 to ST6, determined by ELISA at Day 85. GMTs are calculated based on the number of subjects with non-missing results.
| Arm | Type | Description |
|---|---|---|
| VLA15-1A | EXPERIMENTAL | Participants will receive a single injection in the muscle (IM) of VLA15 at Visits 1, two years after their 4th dose of VLA15 |
| VLA15-1B | PLACEBO_COMPARATOR | Participants will receive a single injection in the muscle (IM) of Saline at Visits 1, two years after their 4th dose of VLA15 |
| VLA15-2A | EXPERIMENTAL | Participants will receive a single injection in the muscle (IM) of VLA15 at Visits 1, one year after their 4th dose of VLA15 |
| VLA15-2B | PLACEBO_COMPARATOR | Participants will receive a single injection in the muscle (IM) of saline at Visits 1, one year after their 4th dose of VLA15 |
| Group 1 | EXPERIMENTAL | Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 3. Injections will be given as intramuscular shots. |
| Group 2 | EXPERIMENTAL | Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 5. Injections will be given as intramuscular shots. |
| Group 3 | EXPERIMENTAL | Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 7. Injections will be given as intramuscular shots. |
| Group 4 | EXPERIMENTAL | Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 9. Injections will be given as intramuscular shots. |
| VLA15 | EXPERIMENTAL | Participants will receive 6-valent OspA-based Lyme disease vaccine (VLA15). |
| Normal Saline (Placebo) | PLACEBO_COMPARATOR | Participants will receive 0.9% sodium chloride solution for injection |
| VLA15 Lot 1 (3-dose primary vaccination series and booster dose) | EXPERIMENTAL | Shot in the deltoid muscle (preferable in the nondominant arm) |
| VLA15 Lot 2 (3-dose primary vaccination series and booster dose) | EXPERIMENTAL | Shot in the deltoid muscle (preferable in the nondominant arm) |
| VLA15 Lot 3 (3-dose primary vaccination series and booster dose) | EXPERIMENTAL | Shot in the deltoid muscle (preferable in the nondominant arm) |
| Placebo (3-dose primary vaccination series and booster dose) | PLACEBO_COMPARATOR | Shot in the deltoid muscle (preferable in the nondominant arm) |
| Part A+B - Group 1 | EXPERIMENTAL | Part A: VLA15 at Month 0, 2 and 6 Part B: VLA15 at Month 18, 30 and 42 |
| 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 |
| 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 |
| VLA15 with Alum lower dose | EXPERIMENTAL | Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued |
| VLA15 with Alum higher dose | EXPERIMENTAL | Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo |
| Placebo | PLACEBO_COMPARATOR | Main Study Phase: placebo - Booster Phase: arm discontinued |
| VLA15 low dose | ACTIVE_COMPARATOR | VLA15 low dose with Alum. |
| VLA15 medium dose | ACTIVE_COMPARATOR | VLA15 medium dose with Alum. |
| VLA15 high dose | ACTIVE_COMPARATOR | VLA15 high dose with Alum. |
| VLA15 12 µg with Alum | ACTIVE_COMPARATOR | VLA15 12 µg (microgram) with Alum has an injection volume of 100 µl (microliter). The amount of Alum per injection is 0.05 mg (milligram). |
| VLA15 12 µg w/o Alum | ACTIVE_COMPARATOR | VLA15 12 µg (microgram) without (w/o) Alum (aluminum hydroxide) has an injection volume of 100 µl (microliter). |
| VLA15 48 µg with Alum | ACTIVE_COMPARATOR | VLA15 48 µg (microgram) with Alum (aluminum hydroxide) has an injection volume of 400 µl (microliter). The amount of Alum per injection is 0.2 mg (milligram). |
| VLA15 48 µg w/o Alum | ACTIVE_COMPARATOR | VLA15 48 µg (microgram) without (w/o) Alum (aluminum hydroxide) has an injection volume of 400 µl (microliter). |
| VLA15 90 µg with Alum | ACTIVE_COMPARATOR | VLA15 90 µg (microgram) with Alum (aluminum hydroxide) has an injection volume of 750 µl (microliter). The amount of Alum per injection is 0.375 mg (milligram). |
| VLA15 90 µg w/o Alum | ACTIVE_COMPARATOR | VLA15 90 µg (microgram) without (w/o) Alum (aluminum hydroxide) has an injection volume of 750 µl (microliter). |
| Name | Type | Description |
|---|---|---|
| VLA15 | BIOLOGICAL | VLA15 injection IM |
| Placebo | BIOLOGICAL | Saline Injection |
| Normal Saline | OTHER | 0.9% sodium chloride solution for injection |
| Saline | OTHER | Shot in the deltoid muscle (preferable in the nondominant arm) |
| VLA15 with Alum | BIOLOGICAL | I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses |
| VLA15 without Alum | BIOLOGICAL | I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses |
Inclusion Criteria: * Participants who are healthy as determined by medical history and clinical judgment. * Participants willing and able to comply with all scheduled visits, IP receipt, and other procedures throughout the study. * Able to provide Informed Consent. * Participants must have receive...
VLA15 is an investigational vaccine being developed to help protect against Lyme disease, also called Lyme borreliosis. It is designed for use in healthy children and adults, with clinical trials enrolling participants from age 5 and older in the United States, Canada, and several European countries.
VLA15 targets outer surface protein A, or OspA, a protein found on Borrelia bacteria. The vaccine is described as 6-valent and OspA-based, meaning it presents multiple OspA variants to the immune system. Targeting OspA is intended to interfere with the bacterium's ability to establish infection after a tick bite.
VLA15 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the Phase 3 clinical program evaluating the vaccine in healthy volunteers.
VLA15 is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by the FDA. The program includes four Phase 3 trials, three of which are completed and one of which is currently recruiting participants.
VLA15 has been studied in four Phase 3 trials. NCT05477524 was a large efficacy, safety, tolerability, immunogenicity, and lot-consistency trial that completed with 12,546 participants. NCT05634811 evaluated safety in healthy children and completed with 3,547 participants. NCT07226882 examined dosing schedules, and NCT07500506 is recruiting to study a fifth dose.