A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)



Status:Completed
Conditions:Pneumonia, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:10/18/2018
Start Date:March 21, 2017
End Date:October 4, 2018

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

A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants

This study is designed to evaluate the safety, tolerability, and immunogenicity of two
different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to <=90 days) of age. The
primary hypothesis of the study is that the proportion of participants receiving V114 who
have serotype specific IgG >=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A,
6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for
recipients of Prevnar 13™.


Inclusion Criteria:

- Infant approximately 2 months of age (42 days to 90 days), inclusive

- In good health

Exclusion Criteria:

- Prior administration of any pneumococcal vaccine

- Known hypersensitivity to any component of the pneumococcal conjugate vaccine or any
diphtheria toxoid-containing vaccine

- Known or suspected impairment of immunological function

- History of congenital or acquired immunodeficiency (eg, splenomegaly)

- Mother has documented human immunodeficiency virus (HIV) infection

- Mother has documented hepatitis B surface antigen-positive test result

- Known or history of functional or anatomic asplenia

- History of failure to thrive

- History of a coagulation disorder

- History of autoimmune disease

- Known neurologic or cognitive behavioral disorder

- Expects to require systemic corticosteroids within 30 days after each vaccination
during the trial

- Prior administration of a blood transfusion or blood products, including
immunoglobulin

- Participated in another clinical trial of an investigational product

- History of invasive pneumococcal disease or known history of other culture-positive
pneumococcal disease
We found this trial at
31
sites
Layton, Utah 84041
Phone: 801-773-8644
?
mi
from
Layton, UT
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
Birmingham, Alabama 35205
Phone: 205-933-8522
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Charleston, South Carolina 29414
Phone: 843-518-5642
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlottesville, Virginia 22902
Phone: 434-872-9384
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Cincinnati, Ohio 45245
Phone: 531-752-3650
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44221
Phone: 216-291-9210
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Dayton, Ohio 45414
Phone: 937-236-5396
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Dothan, Alabama 36305
Phone: 334-836-0172
?
mi
from
Dothan, AL
Click here to add this to my saved trials
Downey, California 90241
Phone: 562-904-2123
?
mi
from
Downey, CA
Click here to add this to my saved trials
East Norriton, Pennsylvania 19401
Phone: 610-277-6400
?
mi
from
East Norriton, PA
Click here to add this to my saved trials
East Syracuse, New York 13057
Phone: 315-464-5102
?
mi
from
East Syracuse, NY
Click here to add this to my saved trials
Ellensburg, Washington 98926
Phone: 509-962-6348
?
mi
from
Ellensburg, WA
Click here to add this to my saved trials
Galveston, Texas
Phone: 409-772-1444
?
mi
from
Galveston, TX
Click here to add this to my saved trials
Haughton, Louisiana 71037
Phone: 318-949-0539
?
mi
from
Haughton, LA
Click here to add this to my saved trials
Hermitage, Pennsylvania 16148
Phone: 724-981-1219
?
mi
from
Hermitage, PA
Click here to add this to my saved trials
Jonesboro, Arkansas 72401
Phone: 870-935-6012
?
mi
from
Jonesboro, AR
Click here to add this to my saved trials
Kingsport, Tennessee 37660
Phone: 423-230-2421
?
mi
from
Kingsport, TN
Click here to add this to my saved trials
League City, Texas 77573
Phone: 409-772-5278
?
mi
from
League City, TX
Click here to add this to my saved trials
Louisville, Kentucky 40202
Phone: 502-852-3774
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Midlothian, Virginia 23113
Phone: 804-794-2299
?
mi
from
Midlothian, VA
Click here to add this to my saved trials
3175 Chemin de la Côte-Sainte-Catherine
Montreal, Quebec H3T 1C5
Phone: 5143454675
?
mi
from
Montreal,
Click here to add this to my saved trials
Murray, Utah 84107
Phone: 801-747-8700
?
mi
from
Murray, UT
Click here to add this to my saved trials
Omaha, Nebraska 68132
Phone: 402-280-1231
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Palmdale, California 93550
Phone: 661-538-9922
?
mi
from
Palmdale, CA
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-955-2357
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Roseville, California 95678
Phone: 510-267-7538
?
mi
from
Roseville, CA
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
South Jordan, Utah 84095
Phone: 801-567-9780
?
mi
from
South Jordan, UT
Click here to add this to my saved trials
Syracuse, New York 13214
Phone: 315-464-5102
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Woburn, Massachusetts 01801
Phone: 781-638-1021
?
mi
from
Woburn, MA
Click here to add this to my saved trials