NCT03313050

A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age

A PHASE 1/2, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY ADULTS 50 THROUGH 85 YEARS OF AGE

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 511 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage. In Stage 1 healthy adults 50 to 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 or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group). In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 \>=2 months prior to investigational product administration will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the licensed 23-valent pneumococcal polysaccharide vaccine (control group).

Conditions

• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Multivalent	Pneumococcal conjugate vaccine
BIOLOGICAL	Tdap	Tetanus, diphtheria, acellular pertussis vaccine
BIOLOGICAL	polysaccharide	23-valent pneumococcal polysaccharide vaccine

Timeline

• Start date: 2017-10-12
• Primary completion: 2019-05-24
• Completion: 2019-05-24
• First posted: 2017-10-18
• Last updated: 2020-06-04
• Results posted: 2020-06-04

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study