Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-08 @ 11:21 AM
Study NCT ID:
NCT03970733
Status:
COMPLETED
Last Update Posted:
2023-04-21
First Post:
2019-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
ALTERNATIVE SCHEDULE STUDY FOR VLA15, A MULTIVALENT RECOMBINANT OSPA BASED VACCINE CANDIDATE AGAINST LYME BORRELIOSIS, IN HEALTHY ADULTS AGED 18 TO 65 YEARS - A RANDOMIZED, CONTROLLED, OBSERVER-BLIND PHASE 2 STUDY.
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the Main Study Phase a total of 246 subjects were randomized 2:2:1 into three treatment groups to receive either VLA15 with Alum (lower or higher dose) or Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1, Day 57 and Day 180.
In the Booster Phase subjects from the higher dose group who completed their primary immunization schedule according to protocol will be randomized 2:1 to receive an additional higher dose VLA15 vaccination or Placebo at Month 18.
Study duration in the Main Study Phase per subject is a maximum of 20 months. Overall study Duration is estimated to be 22 months.
Study duration per subject in the Booster Phase is a maximum of approximately 13 months.
Study duration per subject in the Main Study Phase and Booster Phase together is estimated to be a maximum of approximately 33 months.
Overall study duration (i.e., First-Subject-In to Last-Subject Out/ end of Booster Phase) is estimated to be approximately 37 months.
In the Booster Phase subjects from the higher dose group who completed their primary immunization schedule according to protocol will be randomized 2:1 to receive an additional higher dose VLA15 vaccination or Placebo at Month 18.
Study duration in the Main Study Phase per subject is a maximum of 20 months. Overall study Duration is estimated to be 22 months.
Study duration per subject in the Booster Phase is a maximum of approximately 13 months.
Study duration per subject in the Main Study Phase and Booster Phase together is estimated to be a maximum of approximately 33 months.
Overall study duration (i.e., First-Subject-In to Last-Subject Out/ end of Booster Phase) is estimated to be approximately 37 months.
Detailed Description:
This is a randomized, observer-blind (subject, Sponsor and investigator/site staff involved in Clinical Evaluation of subjects are blinded), Placebo controlled, multicenter Phase 2 study.
In Main Study Phase a total of 246 healthy subjects,aged 18 to 65 years, were randomized 2:2:1 to receive either VLA15 with Alum (lower or higher doser Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1 (Month 0), Day 57 (Month 2) and Day 180 (Month 6).
Subjects from the higher dose group who completed their primary immunization schedule according to protocol, will be randomized 2:1 to receive an additional injection of the higher dose VLA15 with Alum or Placebo in a Booster Phase. The additional vaccination is administered as intramuscular injection approximately 18 months after the first immunization.
In Main Study Phase a total of 246 healthy subjects,aged 18 to 65 years, were randomized 2:2:1 to receive either VLA15 with Alum (lower or higher doser Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1 (Month 0), Day 57 (Month 2) and Day 180 (Month 6).
Subjects from the higher dose group who completed their primary immunization schedule according to protocol, will be randomized 2:1 to receive an additional injection of the higher dose VLA15 with Alum or Placebo in a Booster Phase. The additional vaccination is administered as intramuscular injection approximately 18 months after the first immunization.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| C4601007 | OTHER | Alias Study Number | View |