Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 4

Conditions: Pneumococcal Infection

Treatments: Biological: PNEUMOVAX™ 23

Study type: Interventional

Funder types: Industry

Identifiers

NCT02260882

152859 (Registry Identifier)

V110-902

Details and patient eligibility

About

The purpose of this study is to determine if revaccination with pneumococcal vaccine (PNEUMOVAX™ 23, V110) is well tolerated and produces an immune response in older Japanese adults. The primary hypothesis being tested is that the geometric mean concentration of antibodies to pneumococcal polysaccharide serotypes 3, 6B, and 23F at 4 weeks after revaccination will be superior to that before revaccination in Japanese adults who received a primary vaccination at least 5 years before revaccination.

Enrollment: 243 patients

Sex: All

Ages: 70 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Japanese participant
• Good health or any underlying chronic illness is documented to be in stable condition
• Revaccination Group: received one documented PNEUMOVAX™ 23 vaccination at least 5 years before enrollment in the study
• Primary Vaccination Group: no prior history with PNEUMOVAX™ 23 vaccination Exclusion Criteria:
• Known allergy or sensitivity to any of the components of the study vaccine
• History of pneumococcal conjugate vaccination
• Known or suspected immune dysfunction, immunosuppression, or autoimmune disease. Participants with a history of cancer who are not actively treated and not immunosuppressed will be eligible
• Functional or anatomic asplenia
• Received immunoglobulin within 6 months before study vaccine or is planned during the study
• Received any investigational drugs or vaccines within 2 months before study vaccination
• History of pneumococcal disease (positive culture from blood or other normally sterile site)
• Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
• History of convulsion
• Previously diagnosed with immunodeficiency or has a close relative with congenital immune deficiency
• Participating in any other clinical trial

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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243 participants in 2 patient groups

Revaccination Group

Experimental group

Description:

0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior

Treatment:

Biological: PNEUMOVAX™ 23

Primary Vaccination Group

Experimental group

Description:

0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination

Treatment:

Biological: PNEUMOVAX™ 23