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

QPS Miami Research Associates

6141 Sunset Drive
South Miami, Florida 33143

Phone: 305-598-3125

from

South Miami, FL