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™.

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

sites

J. Lewis Research Inc.-Foothill Family Clinic

Salt Lake City, Utah 84109

Phone: 801-554-0158

from

Salt Lake City, UT