Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03010228 · ClinicalTrials.gov registry record · Phase 1
Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis
A Phase 1 study of Lyme Borreliosis, Nervous System, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 179
- Enrollment target
- 5
- Study locations
NCT03010228: Completed Phase 1 study of Lyme Borreliosis, Nervous System, sponsored by Pfizer.
NCT03010228 is a Phase 1 study of Lyme Borreliosis, Nervous System that has completed, run by Pfizer. The registered enrollment target is 179 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (198% higher). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03010228, a Phase 1 study of Lyme Borreliosis, Nervous System, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 179 participants
- Enrollment target
- 5
- Study locations
Study Summary
Observer-blind, partially randomized, multi-center dose escalation Phase I study in healthy adults below 40 years of age. 180 subjects will be enrolled in 6 treatment groups (different doses; different formulation: with/without adjuvant); vaccinations will be given I.M.(intramuscular) into the deltoid region on Days 0, 28 and 56. Study participants will be followed up until one year after first vaccination. Booster Extension: Subjects in the 48µg and 90µg Treatment groups who received a complete Primary immunization schedule will be included into a Booster Extension 13 months after the first immunization.
Conditions Studied
Interventions
- BIOLOGICAL VLA15 with Alum
- BIOLOGICAL VLA15 without Alum
Study Locations (5)
California
- eStudy Site - La Mesa
- eStudySite - La Mesa
Nebraska
- Celerion Inc. - Lincoln
- Celerion, Inc - Lincoln
Other
- University Hospital Ghent - Ghent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 179 participants |
| Start Date | 2017-01-31 |
| Est. Completion | 2019-01-16 |
| Phase | Phase 1 |
What the finished NCT03010228 record still lists
NCT03010228 is an interventional study that assigns participants to a tested intervention. The registered 179 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (198% higher).
The record links to 1 condition, with Lyme Borreliosis, Nervous System appearing as the primary indexed condition, and to 2 interventions - of which VLA15 with Alum is the first listed.
NCT03010228 lists 5 locations in 3 states (California, Nebraska, Other).
Frequently Asked Questions
What is clinical trial NCT03010228 about?
NCT03010228 is a clinical study titled "Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis". Observer-blind, partially randomized, multi-center dose escalation Phase I study in healthy adults below 40 years of age. 180 subjects will be enrolled in 6 treatment groups (different doses; different formulation: with/without adjuvant); vaccinations will be given I.M.(intramuscular) into the delt...
What is the current status of trial NCT03010228?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 179 participants. The study started on 2017-01-31. Estimated completion is 2019-01-16.
What conditions does trial NCT03010228 study?
This clinical trial studies the following conditions: Lyme Borreliosis, Nervous System.
What interventions are being tested in trial NCT03010228?
The interventions under investigation include: VLA15 with Alum (BIOLOGICAL), VLA15 without Alum (BIOLOGICAL).
Who is sponsoring clinical trial NCT03010228?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03010228 being conducted?
This trial has 5 study locations across California, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03010228's enrollment target sits among peer trials
179 311th of 2000 higher than 1,690 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06581198 · 179 participants · Phase 2
A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
- NCT07356323 · 179 participants · NA
A Prospective, Single-arm, Trial to Determine Contamination Rates When Using an Antibacterial Incise Drape During Orthopedic Surgery
- NCT01558804 · 180 participants
GRoup A StrePtococcus
- NCT02932176 · 180 participants
Machine Learning for Handheld Vascular Studies
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI