A Study to Evaluate the Safety and Immunogenicity of Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Participants 50 Years of Age and Older (V110-029)



Status:Completed
Conditions:Pneumonia, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:50 - Any
Updated:2/7/2015
Start Date:August 2014
End Date:July 2015
Contact:Toll Free Number
Phone:1-888-577-8839

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Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Subjects 50 Years of Age and Older

The purpose of this study is to evaluate the safety and immunogenicity of sequential
administration of Prevnar 13™ and Pneumovax™ 23 in healthy participants 50 years of age
and older. The primary hypotheses in the study are that 1) geometric mean titers (GMTs) to
pneumococcal serotypes 22F and 33F (serotypes in Pneumovax™ 23 but not in Prevnar 13™) are
superior in participants administered Prevnar 13™ followed by Pneumovax™ 23 as compared
with participants administered Prevnar 13™ followed by placebo, and 2) GMTs to pneumococcal
serotypes shared by the two vaccines are non-inferior in participants administered Prevnar
13™ followed by Pneumovax™ 23 as compared with participants administered Prevnar 13™
followed by placebo.


Inclusion Criteria:

- Any chronic illness must be documented to be in stable condition

- Male, or a female and agrees to remain abstinent or use 2 acceptable methods of
contraception through 6 weeks after receiving study vaccination, or a female who is
not of reproductive potential

Exclusion Criteria:

- Is or has an immediate family member who is investigational site or sponsor staff
directly involved with this trial

- Prior administration of any pneumococcal vaccine

- History of invasive pneumococcal disease

- Known hypersensitivity to any component of the pneumococcal polysaccharide vaccine,
of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine

- Known or suspected impairment of immunological function, documented Human
Immunodeficiency Virus (HIV) infection, asplenia, or history of autoimmune disease

- Received systemic corticosteroids (equivalent of >=2 mg/kg total daily dose of
prednisone or >=20 mg/kg for persons weighing >10 kg) for >=14 consecutive days and
has not completed treatment <=30 days before study vaccination, or has received
systemic corticosteroids exceeding physiological doses (~5 mg/day prednisone
equivalent) within 14 days before study vaccination (topical, ophthalmic,
intra-articular, and inhaled/nebulized steroids are permitted).

- Has a coagulation disorder contraindicating intramuscular vaccination

- Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat
cancer or other conditions, and treatments associated with organ or bone marrow
transplantation or autoimmune disease

- Received a blood transfusion or blood products, including immunoglobulins <=6 months
before receiving study vaccine, or is scheduled to receive them within 30 days

- Participated in another clinical study of an investigational product <=2 weeks before
or during the current study

- Is breast-feeding
We found this trial at
18
sites
2267
mi
from 91732
Richmond, VA
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1213
mi
from 91732
Austin, TX
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2016
mi
from 91732
Bristol, TN
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356
mi
from 91732
Chandler, AZ
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Charlotte, North Carolina 28207
2102
mi
from 91732
Charlotte, NC
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2318
mi
from 91732
Coral Gables, FL
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208
mi
from 91732
Las Vegas, NV
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2321
mi
from 91732
Miami, FL
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Mount Pleasant, South Carolina 29464
2187
mi
from 91732
Mount Pleasant, SC
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Mount Pleasant, South Carolina 29464
2187
mi
from 91732
Mount Pleasant, SC
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1450
mi
from 91732
Natchitoches, LA
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1203
mi
from 91732
New Braunfels, TX
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1183
mi
from 91732
Newton, KS
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2245
mi
from 91732
Rochester, NY
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364
mi
from 91732
Sacramento, CA
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570
mi
from 91732
Salt Lake City, UT
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105
mi
from 91732
San Diego, CA
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1182
mi
from 91732
Wichita, KS
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