Safety and Immunogenicity Study of Prophylactic Streptococcus Pneumoniae Vaccine
Public ClinicalTrials.gov record NCT01995617. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of GEN-004, a Streptococcus Pneumoniae Protein Subunit Vaccine, in Adult Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01995617
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 90 participants
Conditions and interventions
Conditions
Interventions
- Placebo Biological
- GEN-004 Low Dose Biological
- GEN-004 Low Dose + Adjuvant Biological
- GEN-004 Mid Dose Biological
- GEN-004 Mid Dose + Adjuvant Biological
- GEN-004 High Dose Biological
- GEN-004 High Dose + Adjuvant Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2013
- Primary completion
- Jan 31, 2015
- Completion
- Jan 31, 2015
- Last update posted
- Dec 10, 2015
2013 – 2015
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Prism Research | Saint Paul | Minnesota | 55114 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01995617, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 10, 2015 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01995617 live on ClinicalTrials.gov.