VLA15 for Lyme Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Lyme DiseaseVLA15 - Biological
Eligibility
5 - 17
All Sexes
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Study Summary

This study is to understand if the study vaccine (called VLA15) is safe in healthy children. We are looking for children who: are healthy are age 5 through 17 have not been diagnosed with any form of Lyme disease in the past have not received any vaccines for Lyme disease in the past Lyme disease happens most often in children of this age. The study vaccine may be used potentially to help prevent Lyme disease. The goal of this study is to get more information about the safety of the study vaccine in this age group. Participants will be in this study for about 2 years. During that time, they will receive VLA15 or placebo (sterile saltwater solution) by a "shot" in the arm. We will compare experience of children receiving VLA15 to those receiving the placebo. Participants will not know whether they get VLA15 or placebo. Everyone participating in this study will: get the shots in a clinic or in a hospital office receive a total of 4 shots receive the first 3 shots within 6 months receive the last shot about 1 year afterwards need to come to the trial site for 6 planned visits; 4 of these are vaccination visits and 2 are follow-up visits. We will contact you by phone 1 time every year during the study to monitor your experience. You may have extra visits if you experience a severe reaction after a vaccine dose.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

5 Primary · 0 Secondary · Reporting Duration: Through study completion, up to 24 months

Month 1
The percentage of participants reporting adverse events (AEs)
Month 24
The percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)
The percentage of participants reporting serious adverse events (SAEs)
Day 7
The percentage of participants reporting prompted local reactions
The percentage of participants reporting prompted systemic events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

VLA15 Low Dose
90%Injection site pain
52%Myalgia
34%Headache
28%Injection site erythema
28%Fatigue
17%Nausea
14%Injection site swelling
10%Injection site induration
10%Influenza like illness
7%Pyrexia
7%Arthralgia
3%Upper respiratory tract infection
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT03769194) in the VLA15 Low Dose ARM group. Side effects include: Injection site pain with 90%, Myalgia with 52%, Headache with 34%, Injection site erythema with 28%, Fatigue with 28%.

Trial Design

2 Treatment Groups

VLA15
1 of 2
Normal Saline (Placebo)
1 of 2

Experimental Treatment

Non-Treatment Group

3000 Total Participants · 2 Treatment Groups

Primary Treatment: VLA15 · Has Placebo Group · Phase 3

VLA15
Biological
Experimental Group · 1 Intervention: VLA15 · Intervention Types: Biological
Normal Saline (Placebo)
Other
PlaceboComparator Group · 1 Intervention: Normal Saline · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VLA15
2018
Completed Phase 2
~580

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, up to 24 months

Who is running the clinical trial?

PfizerLead Sponsor
4,303 Previous Clinical Trials
7,141,278 Total Patients Enrolled
4 Trials studying Lyme Disease
19,376 Patients Enrolled for Lyme Disease
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,277 Previous Clinical Trials
4,851,184 Total Patients Enrolled
3 Trials studying Lyme Disease
18,751 Patients Enrolled for Lyme Disease

Eligibility Criteria

Age 5 - 17 · All Participants · 2 Total Inclusion Criteria

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