A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH)
Status: | Active, not recruiting |
---|---|
Conditions: | Pneumonia, Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 12/2/2018 |
Start Date: | June 22, 2018 |
End Date: | December 30, 2019 |
A Phase 3, Multicenter, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 One Year Later in Healthy Adults 50 Years of Age or Older (PNEU-PATH)
This study is designed 1) to evaluate the safety, tolerability, and immunogenicity of V114
and Prevnar 13™ in healthy adults 50 years of age or older, 2) to describe the safety of
sequential administration of V114 or Prevnar 13™ followed by PNEUMOVAX™23, and 3) to evaluate
the immune responses to the 15 serotypes contained in V114 when PNEUMOVAX™23 is given
approximately 12 months after receipt of either V114 or Prevnar 13™.
and Prevnar 13™ in healthy adults 50 years of age or older, 2) to describe the safety of
sequential administration of V114 or Prevnar 13™ followed by PNEUMOVAX™23, and 3) to evaluate
the immune responses to the 15 serotypes contained in V114 when PNEUMOVAX™23 is given
approximately 12 months after receipt of either V114 or Prevnar 13™.
Inclusion Criteria:
- Male or female in good health
- Female participant: not pregnant, not breastfeeding and 1) not of childbearing
potential, or 2) of childbearing potential and agrees to practice contraception
through 6 weeks after administration of study vaccine.
Exclusion Criteria:
- History of invasive pneumococcal disease
- Known hypersensitivity to any vaccine component
- Known or suspected impairment of immune function
- Coagulation disorder contraindicating intramuscular vaccination
- History of malignancy ≤5 years before enrollment, except for adequately treated basal
cell or squamous cell skin cancer or in situ cervical cancer
- Female participant: positive urine or serum pregnancy test
- Prior administration of any pneumococcal vaccine
- Received systemic corticosteroids for ≥14 consecutive days and have not completed
within 30 days of enrollment
- Received immunosuppressive therapy
- Received a blood transfusion or blood products within 6 months of enrollment
- Participated in another clinical study of an investigational product within 2 months
of enrollment
- Current user of recreational or illicit drugs or history of drug or alcohol abuse or
dependence.
We found this trial at
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sites
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1709 S Rock Rd
Wichita, Kansas 67207
Wichita, Kansas 67207
316-689-6629
Phone: 316-689-6635
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