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NCT05634811 · ClinicalTrials.gov registry record · Phase 3
Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,547
- Enrollment target
NCT05634811 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 3,547 participants.
The verdict
NCT05634811, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,547 participants
- Enrollment target
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.
Interventions
- OTHER Normal Saline
- BIOLOGICAL VLA15
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,547 participants |
| Start Date | 2022-12-12 |
| Est. Completion | 2025-07-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05634811
The ClinicalTrials.gov registry entry for NCT05634811 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,547 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT05634811 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05634811 about?
NCT05634811 is a clinical study titled "Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children". 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...
What is the current status of trial NCT05634811?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,547 participants. The study started on 2022-12-12. Estimated completion is 2025-07-21.
What interventions are being tested in trial NCT05634811?
The interventions under investigation include: Normal Saline (OTHER), VLA15 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05634811?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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