Phase 3
Completed N=3,146
A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults
Source: ClinicalTrials.gov NCT02094586 ↗Enrolled (actual)
3,146
Serious AEs
0.7%
Results posted
Jul 2021
Primary outcomePrimary: Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B — 9220; 10034 Geometric Mean Titer
◆ Published Evidence
Established
21citations · ~3 / year
Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18-45.
Summary
The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.
Linked Publications
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Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18-45.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B |
9220; 10034 | — |
| PRIMARY Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C |
10034; 9827 | — |
| PRIMARY Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C |
9220; 9827 | — |
| SECONDARY SVA Seroconversion at Day 11 |
94; 93; 94; 4 | — |
| SECONDARY SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 |
91; 143; 9922; 320; 6170; 127 | — |
| SECONDARY SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 |
91; 0; 96; 0; 69; 0 | — |
| SECONDARY Adverse Events |
52.99; 50.44; 52.28; 51.90; 43.15; 4.31 | — |
Eligibility Criteria
Inclusion Criteria
- healthy men or women,
- age 18 to 45 years inclusive;
- normal medical history and physical examination
- Women must have a negative pregnancy test.
Exclusion Criteria
- travel to a cholera endemic area in the previous 5 years;
- abnormal stool pattern or regular use of laxatives;
- Currently active unstable or undiagnosed medical conditions
- current or recent antibiotic use;
- pregnancy or nursing;
- Previously received a licensed or investigational cholera vaccine
- History of cholera or enterotoxigenic E. coli infection
- History of Guillain-Barré Syndrome
- Received or plans to receive any other licensed vaccines, except for seasonal influenza
- Recipient of bone marrow or solid organ transplant
- Malignancy (excluding non-melanotic skin cancers) or lymphoproliferative disorders diagnosed or treated during the past 5 years
- Use of systemic chemotherapy in the previous 5 years prior to the study
- any immunosuppressive medical condition
Data sourced from ClinicalTrials.gov (NCT02094586) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.