NCT01646398

A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older

A Phase 3, Randomized, Modified Double-Blind, Active-Controlled Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Japanese Elderly Adults Aged 65 Years Old And Older Who Are Naive To Pneumococcal Vaccine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 764 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.

Conditions

• Pneumococcal Vaccines
• Pneumococcal Conjugate Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	13-valent pneumococcal conjugate vaccine	A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
BIOLOGICAL	23-valent pneumococcal polysaccharide vaccine	A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-07-20
• Last updated: 2013-09-20
• Results posted: 2013-09-20

Locations

8 sites across 1 country: Japan