A trial to evaluate the safety and immune response of a pneumococcal conjugate vaccine in adults 18 years of age and older, who have not previously received a pneumococcal vaccine

Registry ID

EUCTR2018-004279-11

Source registry

EUCTR

Status

Completed

Phase

PHASE3

Sponsor

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

Start date

2019-02-18

Completion date

2019-12-09

Last update

2026-08-16

Conditions

• Pneumococcal Infections

Summary

Primary Safety Objective: -To describe the safety profile of 20vPnC in adults 18 years of age and older. Primary Immunogenicity Objective Cohort 1 (60 Years of Age and Older): -To demonstrate that the immune responses to the 13 serotypes in 13vPnC (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) induced by 20vPnC in adults 60 years of age and older are noninferior to the immune response induced by 13vPnC. - To demonstrate that the immune responses to the 7 additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) induced by 20vPnC in adults 60 years of age and older are noninferior to the immune response induced by PPSV23.

Locations

• , , Sweden

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