Back to resultsA Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
Primary Purpose
Influenza, Human
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Seqirus QIV
Comparator QIV
Sponsored by
About this trial
This is an interventional prevention trial for Influenza, Human
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.
Sites / Locations
- Site 296
- Site 401
- Site 397
- Site 392
- Site 402
- Site 398
- Site 388
- Site 293
- Site 289
- Site 294
- Site 390
- Site 396
- Site 400
- Site 317
- Site 386
- Site 393
- Site 287
- Site 316
- Site 382
- Site 285
- Site 387
- Site 385
- Site 383
- Site 399
- Site 384
- Site 389
- Site 283
- Site 282
- Site 288
- Site 394
- Site 395
- Site 300
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Seqirus Quadrivalent Inactivated Influenza Vaccine
Comparator Quadrivalent Influenza Vaccine
Arm Description
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).
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Outcomes
Primary Outcome Measures
The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.
Noninferiority of Seqirus QIV compared to comparator QIV was assessed by the eight co-primary endpoints of hemagglutination inhibition (HI) antibody geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain included in the vaccines. The GMT ratio is defined as the geometric mean of the postvaccination HI titer for the US-licensed comparator QIV over the geometric mean of the postvaccination HI titer for Seqirus QIV.
The Difference in Seroconversion Rate (SCR) for Each Virus Strain.
Noninferiority of Seqirus QIV compared to Comparator QIV was assessed by the eight co-primary endpoints of HI geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain. The rate of SCR is defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI titer. For the SCR comparison, the difference between the SCR for each virus strain will be determined.
Secondary Outcome Measures
Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions.
Frequency and severity of solicited local adverse reactions (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose
Safety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs).
Frequency and severity of solicited systemic adverse events (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose
Safety Endpoint: The Frequency of Cellulitis-like Reaction.
Frequency of cellulitis-like reaction for at least 28 days after each vaccination dose
Safety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs).
Frequency and severity of unsolicited AEs for at least 28 days (ie, day of vaccination and 27 subsequent days) after each vaccination dose
Safety Endpoint: The Frequency of Serious Adverse Events (SAEs).
Frequency of serious adverse events (SAEs) for 180 days after the last vaccination dose.
Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit)
The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:
- Geometric mean of HI titers prevaccination & postvaccination
Immunogenicity Endpoint: Seroconversion Rate (SCR)
The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:
- SCRs: % of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination titer
Immunogenicity Endpoint: Seroprotection Rate
The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:
- The % of subjects with a titer ≥40 (seroprotection rates) at Day 1 and at Exit Visit
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI)
The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:
- Geometric mean fold increase (GMFI): geometric mean fold titer rise from Day 1 to Exit Visit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02545543
Brief Title
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
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seqirus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2278 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Seqirus Quadrivalent Inactivated Influenza Vaccine
Arm Type
Experimental
Arm Description
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).
Arm Title
Comparator Quadrivalent Influenza Vaccine
Arm Type
Active Comparator
Arm Description
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Intervention Type
Biological
Intervention Name(s)
Seqirus QIV
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Comparator QIV
Other Intervention Name(s)
Fluarix Quadrivalent
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.
Description
Noninferiority of Seqirus QIV compared to comparator QIV was assessed by the eight co-primary endpoints of hemagglutination inhibition (HI) antibody geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain included in the vaccines. The GMT ratio is defined as the geometric mean of the postvaccination HI titer for the US-licensed comparator QIV over the geometric mean of the postvaccination HI titer for Seqirus QIV.
Time Frame
28 days after last vaccination.
Title
The Difference in Seroconversion Rate (SCR) for Each Virus Strain.
Description
Noninferiority of Seqirus QIV compared to Comparator QIV was assessed by the eight co-primary endpoints of HI geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain. The rate of SCR is defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI titer. For the SCR comparison, the difference between the SCR for each virus strain will be determined.
Time Frame
28 days after last vaccination.
Secondary Outcome Measure Information:
Title
Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions.
Description
Frequency and severity of solicited local adverse reactions (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose
Time Frame
7 days after each vaccination.
Title
Safety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs).
Description
Frequency and severity of solicited systemic adverse events (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose
Time Frame
7 days after each vaccination.
Title
Safety Endpoint: The Frequency of Cellulitis-like Reaction.
Description
Frequency of cellulitis-like reaction for at least 28 days after each vaccination dose
Time Frame
28 days after each vaccination.
Title
Safety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs).
Description
Frequency and severity of unsolicited AEs for at least 28 days (ie, day of vaccination and 27 subsequent days) after each vaccination dose
Time Frame
28 days after each vaccination.
Title
Safety Endpoint: The Frequency of Serious Adverse Events (SAEs).
Description
Frequency of serious adverse events (SAEs) for 180 days after the last vaccination dose.
Time Frame
180 days after the last vaccination dose.
Title
Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit)
Description
The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:
- Geometric mean of HI titers prevaccination & postvaccination
Time Frame
28 days after last vaccination.
Title
Immunogenicity Endpoint: Seroconversion Rate (SCR)
Description
The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:
- SCRs: % of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination titer
Time Frame
28 days after last vaccination.
Title
Immunogenicity Endpoint: Seroprotection Rate
Description
The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:
- The % of subjects with a titer ≥40 (seroprotection rates) at Day 1 and at Exit Visit
Time Frame
28 days after last vaccination.
Title
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI)
Description
The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:
- Geometric mean fold increase (GMFI): geometric mean fold titer rise from Day 1 to Exit Visit
Time Frame
28 days after last vaccination.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Physician Seqirus
Organizational Affiliation
Seqirus
Official's Role
Study Director
Facility Information:
Facility Name
Site 296
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
Site 401
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Facility Name
Site 397
City
Ontario
State/Province
California
ZIP/Postal Code
91762
Country
United States
Facility Name
Site 392
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Site 402
City
Sacramento
State/Province
California
ZIP/Postal Code
95822
Country
United States
Facility Name
Site 398
City
San Jose
State/Province
California
ZIP/Postal Code
95127
Country
United States
Facility Name
Site 388
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Site 293
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32934
Country
United States
Facility Name
Site 289
City
Boise
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Site 294
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Site 390
City
Augusta
State/Province
Kansas
ZIP/Postal Code
67010
Country
United States
Facility Name
Site 396
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Site 400
City
Park City
State/Province
Kansas
ZIP/Postal Code
67219
Country
United States
Facility Name
Site 317
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Site 386
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Site 393
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70002
Country
United States
Facility Name
Site 287
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Site 316
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68005
Country
United States
Facility Name
Site 382
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Site 285
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
Facility Name
Site 387
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Facility Name
Site 385
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Site 383
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Site 399
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Site 384
City
Grove City
State/Province
Ohio
ZIP/Postal Code
43123
Country
United States
Facility Name
Site 389
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Site 283
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Site 282
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Site 288
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States
Facility Name
Site 394
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site 395
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Site 300
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28390934
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.
Results Reference
derived
Learn more about this trial
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
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