A Study of the Safety, Tolerability, and Immunogenicity of V114 Compared With Prevnar 13™ in Healthy Adults 65 Years of Age or Older Previously Vaccinated With 23-valent Pneumococcal Polysaccharide Vaccine (V114-007)



Status:Completed
Conditions:Pneumonia, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:65 - Any
Updated:1/16/2016
Start Date:October 2015
End Date:February 2016
Contact:Toll Free Number
Phone:1-888-577-8839

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A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Adults 65 Years of Age or Older Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine

This study is designed to assess the safety, tolerability, and immunogenicity of V114
compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated
with 23-valent pneumococcal polysaccharide vaccine.


Inclusion Criteria:

- Good health; any underlying chronic illness must be documented to be in stable
condition

- Have documented proof of receipt of 23-valent pneumococcal polysaccharide vaccine one
year or longer prior to study entry.

- Male, or postmenopausal female

Exclusion Criteria:

- Prior administration of any pneumococcal vaccine other than 23-valent pneumococcal
polysaccharide vaccine

- History of invasive pneumococcal disease or known history of other culture-positive
pneumococcal disease

- Known hypersensitivity to any vaccine component

- Known or suspected impairment of immune function

- Received systemic corticosteroids for >=14 consecutive days and has not completed
treatment <=30 days prior to study entry, or received systemic corticosteroids
exceeding physiologic replacement doses within 14 days prior to study vaccination

- Coagulation disorder contraindicating intramuscular vaccination

- Receives 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 within the
6 months before receipt of study vaccine or is scheduled to receive a blood
transfusion or blood product within 30 days of receipt of study vaccine. Autologous
blood transfusions are not considered an exclusion criterion

- Participated in another clinical study of an investigational product within 2 months
before the beginning of or any time during the duration of the current clinical study

- User of recreational or illicit drugs or has had a recent history (within the last
year) of drug or alcohol abuse or dependence.
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