Clinical trial NCT02914275: 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.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2016-09-26
Enrollment: 2250
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.
timeFrame: Postvaccination (28 days after last vaccination)
measure: The Difference in Seroconversion Rate (SCR) for Each Virus Strain.
timeFrame: Postvaccination (28 days after last vaccination)
Secondary outcomes:
measure: Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE)
timeFrame: Postvaccination (up to 7 days after vaccination)
measure: Number of Participants With Cellulitis-like Reactions
timeFrame: Postvaccination (up to 28 days after each vaccination)
measure: Number of Participants With Unsolicited AEs
timeFrame: Postvaccination (up to 28 days after vaccination)
measure: Number of Participants With Serious Adverse Events (SAE)
timeFrame: 180 days after the last vaccination dose.
measure: Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain
timeFrame: 28 days after last vaccination.
measure: Seroconversion Rates (SCRs) of Each Virus Strain
timeFrame: 28 days after last vaccination
measure: Seroprotection Rates of Each Virus Strain
timeFrame: 28 days after last vaccination.
measure: Geometric Mean Fold Increase (GMFI) of Each Virus Strain
timeFrame: Prevaccination (Day 1) and Postvaccination (28 days after last vaccination)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 434
state: Alabama
city: Mobile
country: United States
facility: Site 442
state: Alabama
city: Anaheim
country: United States
facility: Site 430
state: California
city: Anaheim
country: United States
facility: Site 437
state: California
city: Downey
country: United States
facility: Site 423
state: California
city: Ontario
country: United States
facility: Site 397
state: California
city: Paramount
country: United States
facility: Site 445
state: California
city: Sacramento
country: United States
facility: Site 402
state: California
city: San Diego
country: United States
facility: Site 425
state: California
city: Miami
country: United States
facility: Site 418
state: Florida
city: Miami
country: United States
facility: Site 426
state: Florida
city: Meridian
country: United States
facility: Site 289
state: Idaho
city: Augusta
country: United States
facility: Site 390
state: Kansas
city: Newton
country: United States
facility: Site 421
state: Kansas
city: Wichita
country: United States
facility: Site 422
state: Kansas
city: Louisville
country: United States
facility: Site 443
state: Kentucky
city: Louisville
country: United States
facility: Site 420
state: Kentucky
city: Louisville
country: United States
facility: Site 441
state: Kentucky
city: Metairie
country: United States
facility: Site 393
state: Louisiana
city: Metairie
country: United States
facility: Site 436
state: Louisiana
city: Binghamton
country: United States
facility: Site 285
state: New York
city: Asheboro
country: United States
facility: Site 429
state: North Carolina
city: Cincinnati
country: United States
facility: Site 446
state: Ohio
city: Dayton
country: United States
facility: Site 427
state: Ohio
city: Charleston
country: United States
facility: Site 419
state: South Carolina
city: Spartanburg
country: United States
facility: Site 439
state: South Carolina
city: Bristol
country: United States
facility: Site 308
state: Tennessee
city: Kingsport
country: United States
facility: Site 444
state: Tennessee
city: Austin
country: United States
facility: Site 283
state: Texas
city: Fort Worth
country: United States
facility: Site 282
state: Texas
city: San Angelo
country: United States
facility: Site 288
state: Texas
city: Layton
country: United States
facility: Site 395
state: Utah
city: Salt Lake City
country: United States
facility: Site 431
state: Utah
city: Salt Lake City
country: United States
facility: Site 424
state: Utah
city: Salt Lake City
country: United States
facility: Site 428
state: Utah
city: West Jordan
country: United States
facility: Site 440
state: Utah
city: West Jordan
country: United States
facility: Site 433
state: Utah
city: West Jordan
country: United States
facility: Site 435
state: Utah
city: Charlottesville
country: United States
facility: Site 438
state: Virginia
Study officials:
References:
citation: Statler VA, Albano FR, Airey J, Sawlwin DC, Graves Jones A, Matassa V, Heijnen E, Edelman J, Marshall GS. Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in children 6-59 months of age: A phase 3, randomized, noninferiority study. Vaccine. 2019 Jan 7;37(2):343-351. doi: 10.1016/j.vaccine.2018.07.036. Epub 2018 Jul 26.