A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:1/25/2019
Start Date:September 27, 2016
End Date:August 11, 2017

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A Phase 3, Randomized, Multicenter, Observer-blinded, Noninferiority Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Inactivated Influenza Virus Vaccine (Seqirus QIV) With a US-licensed Quadrivalent Inactivated Comparator Influenza Virus Vaccine (Comparator QIV) in a Pediatric Population 6 Months Through 59 Months of Age

This is a study to assess the immune (antibody) response and safety of a Seqirus split
virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US
licensed 2016/2017 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric
population 6 months through 59 months of age.


Inclusion Criteria:

- Male or female subject 6 months through to 59 months of age at the time of first
vaccination and born between 36 and 42 weeks of gestation;

- Parent or legally acceptable representative able to provide written informed consent
and be willing and able to adhere to all protocol requirements including blood draws.

- Subject is in generally good health as per the Investigator's medical judgment

Exclusion Criteria:

- History of allergic reactions to egg proteins or any components of the Study Vaccines;

- History of serious adverse reactions to any influenza vaccines;

- History of Guillain-Barré syndrome or other demyelinating disease such as
encephalomyelitis and transverse myelitis;

- History of licensed or investigational influenza vaccination in the last 6 months;

- Clinical signs of active infection and/or an axillary temperature of ≥ 99.5°F / (≥
37.5 °C) on the day of vaccination or within 48 hours preceding vaccination.

- Current or recent, acute or chronic medical conditions that in the opinion of the
Investigator are clinically significant and/or unstable

- History of any seizures, with the exception of a single febrile seizure;

- Self-reported or known seropositivity suggestive of acute or chronic viral infection
for human immunodeficiency virus, hepatitis B or hepatitis C;

- Known or suspected congenital or acquired immunosuppressive conditions;

- Current or recent immunosuppressive or immunomodulatory therapy

- Current or medical history of malignant neoplasms;

- Administration of immunoglobulin and/or any blood products within the previous 90 days
preceding the administration of the Study Vaccine or planned administration during the
study;

- Participation in a clinical trial or use of an investigational compound within 28 days
prior to or 28 days after receiving the Study Vaccine, or plans to enter a study
during this period;

- Vaccination with a licensed vaccine 21 days (for live or inactivated vaccines) prior
to receiving the Study Vaccine, or plans to receive any licensed vaccine prior to the
Study Exit Visit.

- Medical conditions or treatment contraindicating intramuscular vaccination due to
increased risk of bleeding.

- Family members of the employees of the Investigator or study center with direct
involvement in the study, or with other clinical studies under the direction of that
Investigator or study center.
We found this trial at
30
sites
979
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from 98109
Anaheim, CA
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?
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from 98109
Asheboro, NC
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1451
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from 98109
Augusta, KS
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1775
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from 98109
Austin, TX
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2270
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from 98109
Binghamton, NY
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2079
mi
from 98109
Birmingham, AL
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2168
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from 98109
Bristol, TN
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Charleston, South Carolina 29412
2424
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from 98109
Charleston, SC
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2285
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from 98109
Charlottesville, VA
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1967
mi
from 98109
Cincinnati, OH
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1961
mi
from 98109
Dayton, OH
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971
mi
from 98109
Downey, CA
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1660
mi
from 98109
Fort Worth, TX
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2150
mi
from 98109
Kingsport, TN
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682
mi
from 98109
Layton, UT
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1939
mi
from 98109
Louisville, KY
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399
mi
from 98109
Meridian, ID
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2091
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from 98109
Metairie, LA
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2730
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from 98109
Miami, FL
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2151
mi
from 98109
Mobile, AL
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1420
mi
from 98109
Newton, KS
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968
mi
from 98109
Ontario, CA
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974
mi
from 98109
Paramount, CA
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626
mi
from 98109
Sacramento, CA
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701
mi
from 98109
Salt Lake City, UT
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1604
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from 98109
San Angelo, TX
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1065
mi
from 98109
San Diego, CA
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Spartanburg, South Carolina 29303
2239
mi
from 98109
Spartanburg, SC
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707
mi
from 98109
West Jordan, UT
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1435
mi
from 98109
Wichita, KS
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