A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health
Public ClinicalTrials.gov record NCT03819049. 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.
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Official title
A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of 3 different doses of ExPEC10V and to select the optimal dose for further clinical development (Cohort 1). Cohort 2 is aimed to expand the dataset supporting the short- and long-term safety and immunogenicity of the optimal dose of ExPEC10V, selected from the primary analysis results of Cohort 1. Cohort 2 will include participants in stable health with a history of urinary tract infection (UTI) in the past 5 years and will be included in the study to support the plan for late stage development of ExPEC vaccine.
Study identification
- NCT ID
- NCT03819049
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 836 participants
Conditions and interventions
Interventions
- ExPEC10V Biological
- ExPEC4V Biological
- Prevnar 13 Biological
- Placebo Biological
Biological
Eligibility (public fields only)
- Age range
- 60 Years and older
- 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
- Jun 6, 2019 (Actual)
- Primary completion
- Jun 8, 2021 (Actual)
- Completion
- Dec 18, 2024 (Actual)
- Last update posted
- Jun 5, 2026
2019 – 2024
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Optimal Research 2 | Huntsville | Alabama | 35802 | — |
| Optimal Research | Melbourne | Florida | 32934 | — |
| Qps-Mra, Llc | Miami | Florida | 33143 | — |
| Optimal Research 1 | Peoria | Illinois | 61614 | — |
| Synexus Clinical Research US Inc 4 | Evansville | Indiana | 47714 | — |
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | — |
| Synexus Clinical Research US Inc 2 | Richfield | Minnesota | 55432 | — |
| Synexus Clinical Research US Inc 3 | Manhattan | New York | 10017 | — |
| Rochester Clinical Research, Inc | Rochester | New York | 14609 | — |
| Synexus Clinical Research US Inc 1 | Akron | Ohio | 44311 | — |
| Synexus Clinical Research US Inc | Columbus | Ohio | 43212 | — |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03819049, 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 Jun 5, 2026 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03819049 live on ClinicalTrials.gov.