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 |
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.
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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