Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children

NCT05634811 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: C4601012NCT056348112025-000441-15
• Study Type: interventional
• Target: 3,547
• Locations: 1 country
• Sites: 65

Brief 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.

Conditions

Lyme Disease

Keywords

Borreliosis; Borrelia burgdorferi; Spirochetes; Vector-Borne Disease; Lyme Disease Vaccine; VLA15; Outer Surface Protein A (OspA); Ticks

Outcome Measures

Primary Outcomes (17)

• Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 1

  Local reactions included pain at injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.

  From Day 1 through Day 7 after Study Vaccination 1 (Vaccination on Day 1, Month 0)

• Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 2

  Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.

  From Day 1 through Day 7 after Study Vaccination 2 (Vaccination on Day 1, Month 2)

• Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 3

  Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.

  From Day 1 through Day 7 after Study Vaccination 3 (Vaccination on Day 1, Month 6)

• Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 4 (Booster Dose)

  Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.

  From Day 1 through Day 7 after Study Vaccination 4 (Vaccination on Day 1, Month 18)

• Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days After Any Study Vaccination

  Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.

  From Day 1 through Day 7 after any study vaccination

• Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 1

  Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.

  From Day 1 through Day 7 after Study Vaccination 1 (Vaccination on Day 1, Month 0)

• Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 2

  Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.

  From Day 1 through Day 7 after Study Vaccination 2 (Vaccination on Day 1, Month 2)

• Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 3

  Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.

  From Day 1 through Day 7 after Study Vaccination 3 (Vaccination on Day 1, Month 6)

• Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 4 (Booster Dose)

  Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.

  From Day 1 through Day 7 after Study Vaccination 4 (Vaccination on Day 1, Month 18)

• Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days After Any Study Vaccination

  Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.

  From Day 1 through Day 7 after any study vaccination

• Percentage of Participants With AEs Through 1 Month Following Study Vaccination 1

  An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 1 were included in this outcome measure. AEs included both serious AEs (SAEs) and non-SAEs.

  From Day 1 through 1 Month after Study Vaccination 1 (Vaccination on Day 1, Month 0)

• Percentage of Participants With AEs Through 1 Month Following Study Vaccination 2

  An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 2 were included in this outcome measure. AEs included both SAEs and non-SAEs.

  From Day 1 through 1 Month after Study Vaccination 2 (Vaccination on Day 1, Month 2)

• Percentage of Participants With AEs Through 1 Month Following Study Vaccination 3

  An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 3 were included in this outcome measure. AEs included both SAEs and non-SAEs.

  From Day 1 through 1 Month after Study Vaccination 3 (Vaccination on Day 1, Month 6)

• Percentage of Participants With AEs Through 1 Month Following Study Vaccination 4 (Booster Dose)

  An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 4 were included in this outcome measure. AEs included both SAEs and non-SAEs.

  From Day 1 through 1 Month after Study Vaccination 4 (Vaccination on Day 1, Month 18)

• Percentage of Participants With AEs Through 1 Month Following Any Study Vaccination

  An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after any dose were included in this outcome measure.

  From Day 1 through 1 Month after any study vaccination

• Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMCs) Throughout the Study

  An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. NDCMCs included conditions that were undiagnosed prior to study entry (diagnosed while in the study and confirmed not to be a preexisting condition) and that were not considered temporary conditions based upon the expected natural history of the condition. An NDCMC was not reported on AE CRF.

  Throughout the study (from study vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months)

• Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study

  An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other important medical event.

  Throughout the study (from study vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months)

Study Arms (2)

VLA15

EXPERIMENTAL

Participants will receive 6-valent OspA-based Lyme disease vaccine (VLA15).

Biological: VLA15

Normal Saline (Placebo)

PLACEBO COMPARATOR

Participants will receive 0.9% sodium chloride solution for injection

Other: Normal Saline

Interventions

VLA15 BIOLOGICAL

6-valent OspA-based Lyme disease vaccine

Also known as: PF-07307405

VLA15

Normal Saline OTHER

0.9% sodium chloride solution for injection

Normal Saline (Placebo)

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participants and/or participants' parent(s)/guardian who are willing and able to comply with all scheduled visits, study procedures and lifestyle considerations for the duration of the study.

You may not qualify if:

• Female participants that are pregnant, breastfeeding, or have a positive urine pregnancy test at Visit 1. Sexually active females and fertile males unwilling to use contraception as per protocol.
• Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
• Any diagnosis of Lyme disease within the past 3 months.
• Any history of Lyme arthritis, carditis, neuroborreliosis, or other disseminated Lyme Disease (LD), regardless of when diagnosed.
• Known tick bite within the past 4 weeks.
• Congenital or acquired immunodeficiency or other conditions or treatments associated with immunosuppression that would inhibit the ability to mount an immune response to a vaccine.
• Other medical, psychiatric condition, active suicidal ideation/behavior or lab abnormality which increases risk of study participation or, in investigator's judgment is inappropriate for the study.
• Receipt of a previous vaccination for LD.
• Treatment for LD in the 3 months prior to study intervention administration.
• Receipt of blood/plasma products or immunoglobulins within 6 months before study intervention administration through conclusion of the study.
• Receipt of systemic corticosteroids for ≥14 days within 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical corticosteroids are permitted.
• Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months before study intervention administration.
• Current use of any prohibited concomitant medication(s) or participants unwilling/unable to use a permitted concomitant medication(s).
• Participation in other studies involving investigational drugs/vaccines/devices within 28 days prior to study entry and/or during study participation (observational studies are acceptable).
• Investigator site staff, sponsor/sponsor delegates directly involved in the conduct of the study and their family members; site staff supervised by the investigator and their family members.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (65)

UAB Child Health Research Unit (CHRU)

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham - School of Medicine

Birmingham, Alabama, 35233, United States

Location

Lakeview Clinical Research

Guntersville, Alabama, 35976, United States

Location

Coast Clinical Research, LLC

Bellflower, California, 90706, United States

Location

Apex Research Group LLC

Fair Oaks, California, 95628, United States

Location

New England Research Associates

Bridgeport, Connecticut, 06606, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Bio-Medical Research LLC

Miami, Florida, 33144, United States

Location

GCP Research, Global Clinical professionals

St. Petersburg, Florida, 33705, United States

Location

MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research

Tampa, Florida, 33609, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

Tekton Research, LLC.

Chamblee, Georgia, 30341, United States

Location

ASR, LLC

Boise, Idaho, 83702, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Clinical Research Prime Rexburg

Rexburg, Idaho, 83440, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

AMR Clinical

El Dorado, Kansas, 67042, United States

Location

AMR Clinical

Wichita, Kansas, 67207, United States

Location

Kentucky Pediatric/ Adult Research

Bardstown, Kentucky, 40004, United States

Location

All Children Pediatrics

Louisville, Kentucky, 40243, United States

Location

MD Medical Research

Oxon Hill, Maryland, 20745, United States

Location

White Oak Pediatrics

Silver Spring, Maryland, 20904, United States

Location

Sisu BHR

Springfield, Massachusetts, 01103, United States

Location

Michigan Center of Medical Research (MICHMER)

Bingham Farms, Michigan, 48025, United States

Location

Vida Clinical Studies, LLC

Dearborn Heights, Michigan, 48127, United States

Location

Great Lakes Research Institute

Southfield, Michigan, 48075, United States

Location

Clinical Research Institute

Minneapolis, Minnesota, 55402, United States

Location

Velocity Clinical Research, Omaha

Omaha, Nebraska, 68134, United States

Location

Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

IMA Clinical Research Warren

Warren Township, New Jersey, 07059, United States

Location

Velocity Clinical Research, Binghamton

Binghamton, New York, 13905, United States

Location

Buffalo Clinical and Translational Research Center

Buffalo, New York, 14203, United States

Location

Advanced Specialty Care

Commack, New York, 11725, United States

Location

Smith Allergy and Asthma Specialists

Cortland, New York, 13045, United States

Location

Stony Brook Medicine Clinical Research Center

East Setauket, New York, 11733, United States

Location

Upstate Global Health Institute

East Syracuse, New York, 13057, United States

Location

Southampton Hospital

Hampton Bays, New York, 11946, United States

Location

Smith Allergy & Asthma Specialists

Horseheads, New York, 14845, United States

Location

NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

Location

DiGiovanna Institute for Medical Education & Research

North Massapequa, New York, 11758, United States

Location

Rochester Clinical Research, LLC

Rochester, New York, 14609, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Prime Global Research

The Bronx, New York, 10456, United States

Location

Advantage Clinical Trials

The Bronx, New York, 10467, United States

Location

Velocity Clinical Research, Vestal

Vestal, New York, 13850, United States

Location

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, 43213, United States

Location

Allegheny Health and Wellness Pavilion

Erie, Pennsylvania, 16506, United States

Location

Central Erie Primary Care

Erie, Pennsylvania, 16508, United States

Location

Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)

Pittsburgh, Pennsylvania, 15236, United States

Location

Northeast Clinical Trials Group

Scranton, Pennsylvania, 18510, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

Texas Health Resources

Fort Worth, Texas, 76135, United States

Location

C & R Research Services USA

Houston, Texas, 77022, United States

Location

DM Clinical Research - Kool Kids Pediatrics

Houston, Texas, 77065, United States

Location

Research Your Health

Plano, Texas, 75093, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

Location

Pediatric Research of Charlottesville, LLC

Charlottesville, Virginia, 22902, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23226, United States

Location

Frontier Clinical research

Kingwood, West Virginia, 26537, United States

Location

Preston Healthcare Services

Kingwood, West Virginia, 26537, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Lyme Disease; Borrelia Infections; Vector Borne Diseases

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Spirochaetales Infections; Tick-Borne Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: December 12, 2022
• Primary Completion: July 21, 2025
• Study Completion: July 21, 2025
• Last Updated: May 7, 2026
• Results First Posted: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (65)