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

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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
17
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Newton, Kansas 67114
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Augusta, Kansas 67010
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Augusta, Kansas 67010
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Bardstown, Kentucky 40004
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Cerritos, California 90703
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Charleston, South Carolina 29407
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Charlotte, North Carolina 28209
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Norfolk, Nebraska 68701
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Omaha, Nebraska 68134
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Salt Lake City, UT
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Savannah, Georgia 31406
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West Jordan, Utah 84088
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
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