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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 24 months
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 moreSide effects data
From 2020 Phase 2 trial • 572 Patients • NCT0376919490%
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
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
4,595 Previous Clinical Trials
12,865,535 Total Patients Enrolled
5 Trials studying Lyme Disease
14,172 Patients Enrolled for Lyme Disease
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,042,144 Total Patients Enrolled
5 Trials studying Lyme Disease
14,172 Patients Enrolled for Lyme Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with Lyme disease in the last 3 months.I am not pregnant, breastfeeding, and I am willing to use contraception as required.I have been treated for Lyme disease within the last 3 months.I was bitten by a tick in the last 4 weeks.I have been vaccinated for Lyme disease.I am not using any medication that is not allowed in this trial.I have had Lyme disease that affected my joints, heart, nervous system, or was widespread.I am willing and able to follow all study requirements.I have a condition or am receiving treatment that weakens my immune system.I haven't received blood products or immunoglobulins in the last 6 months.I haven't taken immunosuppressants or had radiotherapy in the last 6 months.I am healthy or have stable chronic conditions.I have not taken systemic corticosteroids for more than 2 weeks in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: VLA15
- Group 2: Normal Saline (Placebo)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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