NCT02260882

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

A Study Evaluating the Safety and Immunogenicity of Revaccination With 23-Valent Pneumococcal Polysaccharide Vaccine in Older Japanese Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 70 Years – 89 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pneumococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	PNEUMOVAX™ 23	PNEUMOVAX™ 23 (23-Valent Pneumococcal Polysaccharide Vaccination, V110, PPV23)

Timeline

• Start date: 2014-10-31
• Primary completion: 2015-04-09
• Completion: 2015-04-09
• First posted: 2014-10-09
• Last updated: 2018-10-30
• Results posted: 2016-02-17