A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis (V710-005)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Staphylococcus Aureus Infection

Treatments: Biological: Comparator: Placebo (PBO); Biological: V710 Comparator: Placebo (PBO)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00572910

V710-005

2007_609

Details and patient eligibility

About

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.

Enrollment: 206 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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206 participants in 6 patient groups, including a placebo group

V710 - Group 1

Experimental group

Description:

V710 (60 mcg without MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.

Treatment:

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

V710 - Group 2

Experimental group

Description:

V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.

Treatment:

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

V710 - Group 3

Experimental group

Description:

V710 (60 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.

Treatment:

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

V710 - Group 4

Experimental group

Description:

V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.

Treatment:

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

V710 - Group 5

Experimental group

Description:

V710 (90 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.

Treatment:

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

Biological: V710 Comparator: Placebo (PBO)

Group 6

Placebo Comparator group

Description:

Placebo on Day 1, 28 and 180.

Treatment:

Biological: Comparator: Placebo (PBO)