NCT03642847

Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age

A PHASE 1B, RANDOMIZED, CONTROLLED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINES IN HEALTHY JAPANESE ADULTS 18 TO 49 YEARS OF AGE

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This Phase 1b will describe the safety and immunogenicity of 2 multivalent pneumococcal conjugate vaccine formulations in healthy Japanese adults in the United States.

Conditions

• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Prevnar 13	13 valent Pneumococcal Conjugate
BIOLOGICAL	multivalent pneumococcal conjugate formulation 1	multivalent pneumococcal conjugate formulation 1
BIOLOGICAL	multivalent pneumococcal conjugate formulation 2	multivalent pneumococcal conjugate formulation 2

Timeline

• Start date: 2018-08-29
• Primary completion: 2019-03-29
• Completion: 2019-03-29
• First posted: 2018-08-22
• Last updated: 2019-06-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study