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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: Completed Phase 1 study, sponsored by Genocea Biosciences.
NCT01995617 is a Phase 1 study that has completed, run by Genocea Biosciences. The registered enrollment target is 90 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01995617 record still lists
NCT01995617 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01995617 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01995617's enrollment target sits among peer trials
90 628th of 2000 higher than 1,352 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
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