Phase 2
Completed N=206
A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis (V710-005)(COMPLETED)
Source: ClinicalTrials.gov NCT00572910 ↗Enrolled (actual)
206
Serious AEs
16.4%
Results posted
Aug 2011
Primary outcomePrimary: Geometric Mean Fold-rise (GMFR) in 0657n-specific Immunoglobulin G (IgG) Antibody Concentration From Baseline to 28 Days After the Administration of the Second V710 Vaccination — 18.9; 15.1; 17.8 Ratio
Summary
This is a study to evaluate the safety and immunogenicity of V710 with and without Merck Aluminum Adjuvant (MAA) in adult participants with end-stage kidney disease who are on hemodialysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Fold-rise (GMFR) in 0657n-specific Immunoglobulin G (IgG) Antibody Concentration From Baseline to 28 Days After the Administration of the Second V710 Vaccination |
18.9; 15.1; 17.8 | — |
| PRIMARY Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) |
8; 9; 5; 6; 9; 11 | — |
| SECONDARY GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 28 After the Administration of the First V710 Vaccination |
11.9; 12.9; 12.9 | — |
| SECONDARY GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 180 After the Administration of the First V710 Vaccination |
8.5; 5.7; 7.6 | — |
| SECONDARY GMFR in 0657n-specific IgG Antibody Concentration From Baseline to 56 Days After the Administration of a Single V710 Vaccination |
9.6; 11.8 | — |
| SECONDARY GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints |
22.2; 19.9; 36.3; 24.6; 26.9; 33.7 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with end stage kidney disease and is on hemodialysis
- Female patients who are able to have children must have a negative urine pregnancy tests
Exclusion Criteria
- Developed a serious infection within the past 12 months; allergy to the components of the vaccine
- Has been vaccinated with a live virus within the past 30 days or are scheduled to be vaccinated with a live virus in the next 60 days
- Received V710 vaccine before
Data sourced from ClinicalTrials.gov (NCT00572910). 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.