Clinical trial NCT02545543: A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
Official title: A Phase 3, Randomized, Multicenter, Observer-Blinded, Noninferiority Study to Evaluate the Immunogenicity and Safety of a Seqirus Quadrivalent Inactivated Influenza Virus Vaccine (Seqirus QIV) With a US-Licensed 2015-2016 Quadrivalent Inactivated Comparator Influenza Vaccine (Comparator QIV) in a Pediatric Population 5 Through 17 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2015-09-10
Enrollment: 2278
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
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 2015/2016 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 5 through 17 years of age.


Eligibility criteria: Inclusion Criteria:

* Males or females 5 through 17 years of age on the day of first study vaccination.
* 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 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.
* 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.

Primary outcomes:
measure: The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.
timeFrame: 28 days after last vaccination.
measure: The Difference in Seroconversion Rate (SCR) for Each Virus Strain.
timeFrame: 28 days after last vaccination.
Secondary outcomes:
measure: Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions.
timeFrame: 7 days after each vaccination.
measure: Safety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs).
timeFrame: 7 days after each vaccination.
measure: Safety Endpoint: The Frequency of Cellulitis-like Reaction.
timeFrame: 28 days after each vaccination.
measure: Safety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs).
timeFrame: 28 days after each vaccination.
measure: Safety Endpoint: The Frequency of Serious Adverse Events (SAEs).
timeFrame: 180 days after the last vaccination dose.
measure: Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit)
timeFrame: 28 days after last vaccination.
measure: Immunogenicity Endpoint: Seroconversion Rate (SCR)
timeFrame: 28 days after last vaccination.
measure: Immunogenicity Endpoint: Seroprotection Rate
timeFrame: 28 days after last vaccination.
measure: Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI)
timeFrame: 28 days after last vaccination.
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Site 296
state: Alabama
city: Madera
country: United States
facility: Site 401
state: California
city: Ontario
country: United States
facility: Site 397
state: California
city: Redding
country: United States
facility: Site 392
state: California
city: Sacramento
country: United States
facility: Site 402
state: California
city: San Jose
country: United States
facility: Site 398
state: California
city: Hialeah
country: United States
facility: Site 388
state: Florida
city: Melbourne
country: United States
facility: Site 293
state: Florida
city: Boise
country: United States
facility: Site 289
state: Idaho
city: Peoria
country: United States
facility: Site 294
state: Illinois
city: Augusta
country: United States
facility: Site 390
state: Kansas
city: Newton
country: United States
facility: Site 396
state: Kansas
city: Park City
country: United States
facility: Site 400
state: Kansas
city: Wichita
country: United States
facility: Site 317
state: Kansas
city: Bardstown
country: United States
facility: Site 386
state: Kentucky
city: Metairie
country: United States
facility: Site 393
state: Louisiana
city: Saint Louis
country: United States
facility: Site 287
state: Missouri
city: Bellevue
country: United States
facility: Site 316
state: Nebraska
city: Omaha
country: United States
facility: Site 382
state: Nebraska
city: Binghamton
country: United States
facility: Site 285
state: New York
city: Cary
country: United States
facility: Site 387
state: North Carolina
city: Cincinnati
country: United States
facility: Site 385
state: Ohio
city: Cleveland
country: United States
facility: Site 383
state: Ohio
city: Dayton
country: United States
facility: Site 399
state: Ohio
city: Grove City
country: United States
facility: Site 384
state: Ohio
city: Gresham
country: United States
facility: Site 389
state: Oregon
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: San Antonio
country: United States
facility: Site 394
state: Texas
city: Layton
country: United States
facility: Site 395
state: Utah
city: Salt Lake City
country: United States
facility: Site 300
state: Utah
Study officials:
affiliation: Seqirus
name: Clinical Development Physician Seqirus
role: STUDY_DIRECTOR
References:
citation: 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.