Trials / Completed
CompletedNCT02100631
A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults
A Phase III Randomized, Double-blind, Placebo-controlled Study in Older Adults to Assess Immunogenicity and Clinical Acceptability of a Single-dose of the Live Oral Cholera Vaccine Candidate PXVX0200 O1 Serotype Inaba Strain CVD 103-HgR
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 398 (actual)
- Sponsor
- Bavarian Nordic · Industry
- Sex
- All
- Age
- 46 Years – 64 Years
- Healthy volunteers
- Accepted
Summary
Demonstrate that the vaccine offers protection based on antibody levels in older adults and is similar to antibody levels in adults aged 18-45 following vaccination with PXVX0200.
Detailed description
Demonstrate that seroconversion by classical Inaba vibriocidal antibody at Day 11 in older adults ages 46-64 years (inclusive) was non inferior to seroconversion at Day 11 in younger adults ages 18-45 years following vaccination with PXVX0200.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PXVX0200 | |
| BIOLOGICAL | Placebo |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2015-02-01
- Completion
- 2015-06-01
- First posted
- 2014-04-01
- Last updated
- 2023-06-28
- Results posted
- 2021-04-30
Locations
16 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02100631. Inclusion in this directory is not an endorsement.