A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (V114-021/PNEU-FLU)



Status:Active, not recruiting
Conditions:Pneumonia, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:50 - Any
Updated:3/1/2019
Start Date:September 14, 2018
End Date:June 24, 2019

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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (PNEU-FLU)

This study is designed to evaluate the safety and tolerability of a single dose of V114 when
administered concomitantly and non-concomitantly (i.e., 30 days after) with influenza
vaccine. It will also evaluate whether V114 can be administered concomitantly with influenza
vaccine without impairing the antibody responses to the 15 serotypes contained in V114 and to
the 4 influenza viruses contained in the seasonal inactivated quadrivalent influenza vaccine
(QIV). The primary hypotheses state that immune responses to V114 and to QIV are non-inferior
when administered concomitantly as compared with non-concomitant administration. This study
will also contribute to the overall safety database and immunogenicity data for V114 to
support initial licensure in adults.


Inclusion Criteria:

- In good health. Any underlying chronic illness must be documented to be in stable
condition.

- A female participant is eligible to participate if she is not pregnant, not
breastfeeding, and at least 1 of the following conditions applies: a) not a woman of
childbearing potential (WOCBP) OR b) a WOCBP who agrees to use 1 of the contraceptive
methods as defined in the protocol during the treatment period and for at least 6
weeks after the last dose of study intervention.

Exclusion Criteria:

- History of invasive pneumococcal disease (IPD, positive blood culture, positive
cerebrospinal fluid culture, or positive culture at another sterile site) or known
history of other culture-positive pneumococcal disease within 3 years before Visit 1
(Day 1)

- Known hypersensitivity to any component of pneumococcal polysaccharide vaccine,
pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine

- Known hypersensitivity to any component of influenza vaccines, including egg protein,
or following a previous dose of any influenza vaccine

- Known or suspected impairment of immunological function

- Experienced Guillain-Barré syndrome within 6 weeks of receiving a previous influenza
vaccination

- Coagulation disorder contraindicating intramuscular vaccinations.

- History of malignancy ≤5 years prior to signing informed consent, except for
adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer

- A WOCBP who has a positive urine or serum pregnancy test before the first vaccination
at Visit 1 (Day 1)

- Prior administration of any PCV (e.g., Prevnar 13™) or is expected to receive any
pneumococcal vaccine during the study outside of the protocol

- Prior administration of PNEUMOVAX™23 ≤12 months before Visit 1 (Note: individuals who
received PNEUMOVAX™23 >12 months prior to Visit 1 are eligible for this study)

- Previous receipt of influenza vaccine during the 2018/2019 flu season or expected to
receive any influenza vaccine during the study outside of the protocol

- Received systemic corticosteroids (≥20 mg/day prednisone equivalent) for ≥14
consecutive days and has not completed intervention at least 30 days before study
entry

- Received systemic corticosteroids exceeding physiologic replacement doses
(approximately 5 mg/day prednisone equivalent) within 14 days before vaccination
(Note: Topical, ophthalmic, intra-articular or soft-tissue [e.g., bursa, tendon
steroid injections], and inhaled/nebulized steroids are permitted)

- Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat
cancer or other conditions, and interventions associated with organ or bone marrow
transplantation, or autoimmune disease

- Received a blood transfusion or blood products, including immunoglobulin 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.

- Is currently participating in or has participated in an interventional clinical study
with an investigational compound or device within 2 months of participating in this
current study

- Is a user of recreational or illicit drugs or has had a recent history (within the
last year) of drug or alcohol abuse or dependence as assessed by the study
investigator

- Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or
child) who is investigational site or Sponsor staff directly involved with this study.
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7261 Sheridan Street
Hollywood, Florida 33024
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
Phone: 205-757-8212
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Bardstown, Kentucky 40004
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Endwell, New York 13760
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