A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
NCT ID: NCT02545543
Last Updated: 2018-05-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2278 participants
INTERVENTIONAL
2015-09-30
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Seqirus Quadrivalent Inactivated Influenza Vaccine
The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Seqirus QIV
Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
Comparator Quadrivalent Influenza Vaccine
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV
The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
Interventions
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Seqirus QIV
Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
Comparator QIV
The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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. Participant assent will also be obtained if required.
* If applicable, females of childbearing potential (ie, ovulating, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen until at least 28 days after the last Study Vaccine. Females of childbearing potential must return a negative urine pregnancy test result, prior to any vaccination dose with the Study Vaccine.
Exclusion Criteria
* History of serious adverse reactions to any influenza vaccines.
* History of Guillain-Barré syndrome or other demyelinating disease.
* History of licensed or investigational influenza vaccination in the last 6 months.
* Clinical signs of active infection and/or an oral temperature of ≥ 100°F (37.8°C) on the day of planned Study Vaccine administration 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 (such as illness exacerbations) within the preceding 30 days.
* 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, as follows:
* Chronic or long-term systemic corticosteroids: ≥ 0.125 mg/kg/day of oral prednisolone or equivalent daily;
* Sporadic systemic corticosteroids: ≥ 0.5 mg/kg/day of oral prednisolone or equivalent for two or more short courses of \> 3 days in the 3 months preceding vaccination;
* Antineoplastic chemotherapy or radiation therapy within the 6 months preceding vaccination.
Note: Use of topical, inhalant or localised tissue injections of corticosteroids prior to administration of the Study Vaccine or throughout the study are acceptable.
* Administration of immunoglobulin and/or any blood products within the 3 months preceding vaccination, or planned administration during the study.
* Participation in a clinical trial or use of an investigational compound within 28 days prior to the first dose of Study Vaccine, or within 28 days after receiving the final indicated dose of Study Vaccine, or plans to enter a study during this period.
* Vaccination with a licensed vaccine 28 days (for live or inactivated vaccines) prior to receiving the first dose of Study Vaccine, or plans to receive any licensed vaccine prior to the Study Exit Visit.
* Pregnant or lactating females.
5 Years
17 Years
ALL
Yes
Sponsors
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Seqirus
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Physician Seqirus
Role: STUDY_DIRECTOR
Seqirus
Locations
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Site 296
Huntsville, Alabama, United States
Site 401
Madera, California, United States
Site 397
Ontario, California, United States
Site 392
Redding, California, United States
Site 402
Sacramento, California, United States
Site 398
San Jose, California, United States
Site 388
Hialeah, Florida, United States
Site 293
Melbourne, Florida, United States
Site 289
Boise, Idaho, United States
Site 294
Peoria, Illinois, United States
Site 390
Augusta, Kansas, United States
Site 396
Newton, Kansas, United States
Site 400
Park City, Kansas, United States
Site 317
Wichita, Kansas, United States
Site 386
Bardstown, Kentucky, United States
Site 393
Metairie, Louisiana, United States
Site 287
St Louis, Missouri, United States
Site 316
Bellevue, Nebraska, United States
Site 382
Omaha, Nebraska, United States
Site 285
Binghamton, New York, United States
Site 387
Cary, North Carolina, United States
Site 385
Cincinnati, Ohio, United States
Site 383
Cleveland, Ohio, United States
Site 399
Dayton, Ohio, United States
Site 384
Grove City, Ohio, United States
Site 389
Gresham, Oregon, United States
Site 283
Austin, Texas, United States
Site 282
Fort Worth, Texas, United States
Site 288
San Angelo, Texas, United States
Site 394
San Antonio, Texas, United States
Site 395
Layton, Utah, United States
Site 300
Salt Lake City, Utah, United States
Countries
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References
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Airey J, Albano FR, Sawlwin DC, Jones AG, Formica N, Matassa V, Leong J. Immunogenicity and safety of a quadrivalent inactivated influenza virus vaccine compared with a comparator quadrivalent inactivated influenza vaccine in a pediatric population: A phase 3, randomized noninferiority study. Vaccine. 2017 May 9;35(20):2745-2752. doi: 10.1016/j.vaccine.2017.03.028. Epub 2017 Apr 5.
Other Identifiers
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CSLCT-QIV-13-02
Identifier Type: -
Identifier Source: org_study_id
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