NCT03313037

Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age

A PHASE 2, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS 60 THROUGH 64 YEARS OF AGE

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 444 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 60 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy adults aged 60 through 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine followed 1 month later with a dose of saline or Prevnar 13 followed 1 month later with a dose of PPSV23 (control group).

Conditions

• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Multivalent	Pneumococcal conjugate vaccine
BIOLOGICAL	Prevnar 13	Pneumococcal conjugate vaccine
BIOLOGICAL	PPSV23	Pneumococcal polysaccharide vaccine
OTHER	Saline	Placebo

Timeline

• Start date: 2017-10-10
• Primary completion: 2018-12-10
• Completion: 2018-12-10
• First posted: 2017-10-18
• Last updated: 2019-12-26
• Results posted: 2019-12-26

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study