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Cancer Vaccine

Lyme Disease Vaccine for Healthy Children

Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 24 months
Awards & highlights
Pivotal Trial

Study Summary

This trial is to see if a vaccine called VLA15 is safe in healthy 5-17 year olds who have not had Lyme disease or a Lyme vaccine before. Participants will receive 4 shots/year for 2 years & be monitored.

Who is the study for?
Healthy children aged 5-17 who have never had Lyme disease or received a Lyme vaccine can join this study. They must be able to follow the study schedule and their parents/guardians agree to it. Kids with stable chronic conditions may participate, but those recently treated for Lyme, with known tick bites, on certain medications, or girls who are pregnant cannot.Check my eligibility
What is being tested?
The trial is testing VLA15, a new vaccine aimed at preventing Lyme disease in kids. Participants will get either VLA15 or a placebo (normal saline) shot without knowing which one they receive. The study involves four shots over about two years and six clinic visits plus phone check-ins.See study design
What are the potential side effects?
While specific side effects aren't listed here, common reactions to vaccines include pain at the injection site, swelling, redness, fever, headache and feeling tired. Severe allergic reactions are rare but possible.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The percentage of participants reporting adverse events (AEs)
The percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)
The percentage of participants reporting prompted local reactions
+2 more

Side effects data

From 2020 Phase 2 trial • 572 Patients • NCT03769194
90%
Injection site pain
52%
Myalgia
34%
Headache
28%
Fatigue
28%
Injection site erythema
17%
Nausea
14%
Injection site swelling
10%
Injection site induration
10%
Influenza like illness
7%
Pyrexia
7%
Arthralgia
3%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
VLA15 Low Dose
Placebo
VLA15 Medium Dose
VLA15 High Dose

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VLA15Experimental Treatment1 Intervention
Participants will receive 6-valent OspA-based Lyme disease vaccine (VLA15).
Group II: Normal Saline (Placebo)Placebo Group1 Intervention
Participants will receive 0.9% sodium chloride solution for injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VLA15
2018
Completed Phase 2
~820

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,542 Previous Clinical Trials
10,141,971 Total Patients Enrolled
5 Trials studying Lyme Disease
10,622 Patients Enrolled for Lyme Disease
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,455 Previous Clinical Trials
7,323,294 Total Patients Enrolled
5 Trials studying Lyme Disease
10,622 Patients Enrolled for Lyme Disease

Media Library

VLA15 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05634811 — Phase 3
Lyme Disease Research Study Groups: VLA15, Normal Saline (Placebo)
Lyme Disease Clinical Trial 2023: VLA15 Highlights & Side Effects. Trial Name: NCT05634811 — Phase 3
VLA15 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05634811 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor open to individuals over the age of thirty?

"This clinical trial is open to applicants aged 5-17, with 4 studies specifically targeting minors and 7 for those 65 or older."

Answered by AI

Are there any potential dangers associated with the use of VLA15?

"Our team at Power has assigned VLA15 a score of 3, which indicates prior clinical data that supports both its efficacy and safety. This is based on the fact it's currently in Phase 3 of trials."

Answered by AI

How many locales are managing this research endeavor?

"Pediatric Research of Charlottesville, LLC in Charlottesville, Virginia, Stamford Therapeutics Consortium in Stamford, Connecticut and Prime Global Research in Bronx, New york are the primary sites for this study. Additionally there are 4 other medical centres participating as well."

Answered by AI

Are there currently opportunities to participate in this trial?

"Clinicaltrials.gov has registered that this medical trial is no longer recruiting patients, with the initial post date being December 1st 2022 and it's most recent update on December 9th 2022. However, nine other trials are actively enrolling participants at present."

Answered by AI

Who meets the criteria for inclusion in this clinical trial?

"This clinical trial is enrolling 3000 participants aged 5 to 17 suffering from Lyme disease. To qualify, applicants must be in good health and free of chronic medical conditions or possess a condition that has been deemed stable by medical professionals. Furthermore, all patients (or their guardians) must agree to abide with the study's procedure for the entire duration of its running time."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
Arizona
Other
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
~1726 spots leftby Jun 2025