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

Use our guide to learn which trials are right for you!

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.
We found this trial at
45
sites
Rochester, New York 14609
Phone: 585-288-0890
?
mi
from
Rochester, NY
Click here to add this to my saved trials
2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
Phone: 205-757-8212
Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
2128 W Flagler St # 201
Miami, Florida 33144
Phone: 305-631-6704
?
mi
from
Miami, FL
Click here to add this to my saved trials
400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
?
mi
from
Warwick, RI
Click here to add this to my saved trials
Allen, Texas 75013
Phone: 972-900-3538
?
mi
from
Allen, TX
Click here to add this to my saved trials
Augusta, Kansas 67010
Phone: 316-689-6629
?
mi
from
Augusta, KS
Click here to add this to my saved trials
Bardstown, Kentucky 40004
Phone: 502-349-1569
?
mi
from
Bardstown, KY
Click here to add this to my saved trials
Bristol, Tennessee 37620
Phone: 423-990-2413
?
mi
from
Bristol, TN
Click here to add this to my saved trials
Cary, North Carolina 27518
Phone: 919-342-3447
?
mi
from
Cary, NC
Click here to add this to my saved trials
Chandler, Arizona 85224
Phone: 480-775-1115
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Charlottesville, Virginia 22911
Phone: 434-817-2442
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Colorado Springs, Colorado 80909
Phone: 719-377-3663
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Endwell, New York 13760
Phone: 60775438638
?
mi
from
Endwell, NY
Click here to add this to my saved trials
Evanston, Illinois 60201
Phone: 847-869-1191
?
mi
from
Evanston, IL
Click here to add this to my saved trials
Flossmoor, Illinois 60422
Phone: 708-388-2245
?
mi
from
Flossmoor, IL
Click here to add this to my saved trials
Fort Worth, Texas 76135
Phone: 817-238-7254
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fountain Valley, California 92708
Phone: 714-875-4356
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
Georgetown, Texas 78626
Phone: 512-763-4095
?
mi
from
Georgetown, TX
Click here to add this to my saved trials
Hazelwood, Missouri 63042
Phone: 314-972-9600
?
mi
from
Hazelwood, MO
Click here to add this to my saved trials
Hialeah, Florida 33012
Phone: 305-825-6588
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
7261 Sheridan Street
Hollywood, Florida 33024
Phone: 954-990-7649
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Kingsport, Tennessee 37660
Phone: 423-230-2436
?
mi
from
Kingsport, TN
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
3700 North Classen Boulevard
Lindsay, Oklahoma 73052
Phone: 405-606-3900
?
mi
from
Lindsay, OK
Click here to add this to my saved trials
Marlborough, Massachusetts 01752
Phone: 508-320-9248
?
mi
from
Marlborough, MA
Click here to add this to my saved trials
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
Miami, Florida
Phone: 305-961-1671
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33186
Phone: 305-520-5750
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Lakes, Florida 33014
Phone: 786-362-5763
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
Phone: 843-849-1880
?
mi
from
Mount Pleasant, SC
Click here to add this to my saved trials
Nashville, Tennessee 37203
Phone: 615-329-0197
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Windsor, New York 12553
Phone: 844-337-8839
?
mi
from
New Windsor, NY
Click here to add this to my saved trials
Newton, Kansas 67114
Phone: 316-804-7306
?
mi
from
Newton, KS
Click here to add this to my saved trials
Northridge, California 91325
Phone: 818-280-4220
?
mi
from
Northridge, CA
Click here to add this to my saved trials
Paramount, California 90723
Phone: 562-633-5101
?
mi
from
Paramount, CA
Click here to add this to my saved trials
Richmond, Virginia
Phone: 804-477-3045
?
mi
from
Richmond, VA
Click here to add this to my saved trials
San Antonio, Texas 78229
Phone: 210-614-8351
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92123
Phone: 858-278-3647
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Diego, California 92103
Phone: 619-291-2321
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Santa Fe, New Mexico 87505
Phone: 505-395-2003
?
mi
from
Santa Fe, NM
Click here to add this to my saved trials
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
Springfield, Illinois 62703
Phone: 21752875414664
?
mi
from
Springfield, IL
Click here to add this to my saved trials
Valley Village, California 91607
Phone: 8008318308123
?
mi
from
Valley Village, CA
Click here to add this to my saved trials
Wauwatosa, Wisconsin 53226
Phone: 414-727-8131
?
mi
from
Wauwatosa, WI
Click here to add this to my saved trials
Wyomissing, Pennsylvania 19610
Phone: 610-375-2466
?
mi
from
Wyomissing, PA
Click here to add this to my saved trials