A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006)



Status:Completed
Conditions:Pneumonia, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:50 - Any
Updated:12/19/2015
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 Pneumococcal Vaccine-Naïve Adults 50 Years of Age or Older

This study is designed to assess the effect of two different formulations of pneumococcal
polysaccharide vaccine on safety and immunogenicity of V114 in healthy adults 50 years of
age and older.


Inclusion Criteria:

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

- Highly unlikely to conceive through 6 weeks after administration of the study vaccine

Exclusion Criteria:

- Prior administration of any pneumococcal 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

- Breast feeding

- 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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