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

Status:	Active, not recruiting
Conditions:	Pneumonia, Infectious Disease
Therapuetic Areas:	Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	50 - 85
Updated:	12/19/2018
Start Date:	October 12, 2017
End Date:	May 24, 2019

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

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).

Inclusion Criteria:

- Stage 1: Healthy male or female adults 50 to 64 years of age with no history of
pneumococcal vaccination

- Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated
with Prevnar 13 >= 2 months prior to investigational product administration

Exclusion Criteria:

- Stage 1: Vaccination within 12 months before investigational product administration
with diphtheria-, pertussis-, or tetanus-containing vaccine

- Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior
dose of Prevnar 13

We found this trial at

sites

Heartland Research Associates

Newton, Kansas 67114

from

Newton, KS