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NCT01995617 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity Study of Prophylactic Streptococcus Pneumoniae Vaccine
A Phase 1 study, sponsored by Genocea Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
NCT01995617 is a Phase 1 study that has completed, run by Genocea Biosciences. The registered enrollment target is 90 participants.
The verdict
NCT01995617, a Phase 1 study, has completed, sponsored by Genocea Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
Study Summary
GEN-004 is a combination of 3 conserved proteins from Streptococcus pneumoniae. This is a randomized, double-blind, placebo-controlled, dose escalation study. Eligible subjects (male and non-pregnant female) will be assigned sequentially to 1 of 3 dose cohorts and randomized in a 3:1:1 ratio to receive GEN-004 with adjuvant, GEN-004 without adjuvant, or placebo, respectively. Each subject will receive up to 3 doses at 4 week intervals. Subjects will be followed for safety, tolerability, and immunogenicity for 12 months after their last dose.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL GEN-004 Low Dose
- BIOLOGICAL GEN-004 Low Dose + Adjuvant
- BIOLOGICAL GEN-004 Mid Dose
- BIOLOGICAL GEN-004 Mid Dose + Adjuvant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01995617
The ClinicalTrials.gov registry entry for NCT01995617 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genocea Biosciences, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01995617 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01995617 about?
NCT01995617 is a clinical study titled "Safety and Immunogenicity Study of Prophylactic Streptococcus Pneumoniae Vaccine". GEN-004 is a combination of 3 conserved proteins from Streptococcus pneumoniae. This is a randomized, double-blind, placebo-controlled, dose escalation study. Eligible subjects (male and non-pregnant female) will be assigned sequentially to 1 of 3 dose cohorts and randomized in a 3:1:1 ratio to rece...
What is the current status of trial NCT01995617?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2013-11. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01995617?
The interventions under investigation include: Placebo (BIOLOGICAL), GEN-004 Low Dose (BIOLOGICAL), GEN-004 Low Dose + Adjuvant (BIOLOGICAL), GEN-004 Mid Dose (BIOLOGICAL), GEN-004 Mid Dose + Adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT01995617?
This trial is sponsored by Genocea Biosciences, which has 9 total clinical trials registered on ClinicalTrials.gov.
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