Lyme borreliosis
Conditions
Interventions
Product Name: PF-07307405
Product Code: VLA15
Pharmaceutical Form: Injection
INN or Proposed INN: Lip-D1B2B
Other descriptive name: Borrelia burgdorferi, serotype 1, outer surface protein A fused via
Sponsors
Pfizer, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? yes Number of subjects for this age range: 300 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 |
|---|---|
| Main Objective: Safety: • To assess the safety and tolerability profile of VLA15, given in a three- or two dose primary immunization schedule (Month 0-2-6 or Month 0-6), in a healthy study population aged 5 to 65 years up to Day 208 (Month 7). Immunogenicity: • To assess the immune response to VLA15, given in a three- or two dose primary immunization schedule (Month 0-2-6 or Month 0-6), in a healthy study population aged 5 to 65 years at Day 208 (Month 7).;Secondary Objective: Safety: • To assess the safety and tolerability profile of VLA15, given in a three- or two dose primary immunization schedule (Month 0-2-6 or Month 0-6), in a healthy study population aged 5 to 65 years, up to one year after the last primary vaccination (Month 18). • To assess the safety and tolerability profile of VLA15 booster vaccinations (i.e., Booster 1 at Month 18, one year after completion of the primary vaccination schedule, Booster 2 at Month 30 and Booster 3 at Month 42) until study end. Immunogenicity: • To assess the immune response to VLA15, applied in a three- or two dose primary immunization schedule (Month 0-2-6 or Month 0-6), in a healthy study population aged 5 to 65 years, up to one year after the last primary vaccination (Month 18). • To assess the immune response of VLA15 booster vaccinations (i.e., Booster 1 at Month 18, one year after completion of the primary vaccination schedule, Booster 2 at Month 30 and Booster 3 at Month 42) until study end.;Primary end point(s): Safety: + Frequency of solicited local and solicited systemic AEs within 7 days after each and any vaccination of the primary vaccination series (Part A). Immunogenicity: + GMTs (Geometric Mean Titers) for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay, at Day 208/Month 7 (Part A).;Timepoint(s) of evaluation of this end point: The primary endpoint was evaluated at Day 208 (which is one month after completion of primary vaccination series) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: + Frequency of solicited local and solicited systemic AEs within 7 days after each booster dose administration (Part B); + Frequency of SAEs during the entire study; + Frequency of AESIs during the entire study; + Frequency of unsolicited AEs within 28 days after each vaccination; + Frequency of SAEs, AESIs, unsolicited and solicited AEs stratified by age cohort. Immunogenicity: Part A: Main Study Phase: + GMTs for IgG against each OspA serotype (ST1 to ST6), determined by an IgG binding assay, at baseline (screening visit) and at Day 85, 180, 194, 365 and Month 18; + SCRs (Seroconversion Rate, defined as seroconversion from seronegative to seropositive or =four-fold increase in IgG titer compared to baseline if subject was tested OspA seropositive at baseline) for each OspA serotype specific IgG (ST1 to ST6), determined by an IgG binding assay, at Day 85, 180, 194, 208, 365 and Month 18; + GMFRs (Geometric Mean of the fold rise as compared to baseline) for IgG against each OspA serotype (ST1 to ST6), determined by an IgG binding assay, at Day 85 and 208; + GMTs, SCRs and GMFRs for IgG against each OspA serotype (ST1 to ST6), determined by an IgG binding assay, at specified time-points, stratified by age cohort. Part B: Booster Phase: + GMTs for IgG against each OspA serotype (ST1 to ST6), determined by an IgG binding assay, at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48; + SCRs for each OspA serotype specific IgG (ST1 to ST6), determined by an IgG binding assay, at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48; + GMFRs for IgG against each OspA serotype (ST1 to ST6), determined by an IgG binding assay, at Months 19, 31 and 43; + GMTs, SCRs and GMFRs for IgG against each OspA serotype (ST1 to ST6), determined by an IgG binding assay, at specified time points, stratified by age cohort.;Timepoint(s) of evaluation of this end point: Solicited: AEs were assessed within 7 days after each vaccine. Unsolicited: AEs were assessed w | — |
Countries
United States
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer, Inc
Outcome results
None listed