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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 is a Phase 1 study of Lyme Borreliosis, Nervous System that has completed, run by Pfizer. The registered enrollment target is 179 participants. The trial reports 5 study locations across 3 states.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03010228
The ClinicalTrials.gov registry entry for NCT03010228 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 179 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 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 reports 5 study locations spanning 3 distinct geographic areas - top geographies include 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.
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