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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 up to 5 years
Awards & highlights
Pivotal Trial

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.
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.
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 ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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
4,675 Previous Clinical Trials
28,713,946 Total Patients Enrolled
5 Trials studying Lyme Disease
14,176 Patients Enrolled for Lyme Disease
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,754,802 Total Patients Enrolled
5 Trials studying Lyme Disease
14,176 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
~558 spots leftby Jun 2025
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