Influenza, HumanPhase 3NCT02545543
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
A Phase 3 study testing Seqirus QIV and Comparator QIV in people with Influenza, Human, run by Seqirus at 32 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Seqirus QIV and Comparator QIV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,278 participants
- Where
- 32 sitesUnited States
- Study dates
- Sep 2015to Jun 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Site 390
Augusta, Kansas, 67010
Site 283
Austin, Texas, 78705
Site 386
Bardstown, Kentucky, 40004
Site 316
Bellevue, Nebraska, 68005
Site 285
Binghamton, New York, 13901
Site 289
Boise, Idaho, 83642
Site 387
Cary, North Carolina, 27511
Site 385
Cincinnati, Ohio, 45246
Site 383
Cleveland, Ohio, 44122
Site 399
Dayton, Ohio, 45414
Site 282
Fort Worth, Texas, 76135
Site 389
Gresham, Oregon, 97030
Site 384
Grove City, Ohio, 43123
Site 388
Hialeah, Florida, 33012
Site 296
Huntsville, Alabama, 35802
Site 395
Layton, Utah, 84041
Site 401
Madera, California, 93637
Site 293
Melbourne, Florida, 32934
Site 393
Metairie, Louisiana, 70002
Site 396
Newton, Kansas, 67114
Site 382
Omaha, Nebraska, 68114
Site 397
Ontario, California, 91762
Site 400
Park City, Kansas, 67219
Site 294
Peoria, Illinois, 61614
Site 392
Redding, California, 96001
Site 402
Sacramento, California, 95822
Site 300
Salt Lake City, Utah, 84124
Site 288
San Angelo, Texas, 76904
Site 394
San Antonio, Texas, 78229
Site 398
San Jose, California, 95127
Site 287
St Louis, Missouri, 63141
Site 317
Wichita, Kansas, 67207
About this study
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
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.
- Conditions
- Influenza, Human
- Being tested
- Seqirus QIV, Comparator QIV
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seqirus QIVBiological
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 QIVBiological
Also called Fluarix Quadrivalent
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.
| Study group | Role | What they receive |
|---|---|---|
| Seqirus Quadrivalent Inactivated Influenza Vaccine | Experimental | 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). Receives: Biological: Seqirus QIV |
| Comparator Quadrivalent Influenza Vaccine | Active comparator | The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season. Receives: Biological: Comparator QIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days after last vaccination.
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.
Measured: 28 days after last vaccination.
Secondary outcomes (9)
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
Measured: 7 days after each vaccination.
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
Measured: 7 days after each vaccination.
Safety Endpoint: The Frequency of Cellulitis-like Reaction.
Frequency of cellulitis-like reaction for at least 28 days after each vaccination dose
Measured: 28 days after each vaccination.
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
Measured: 28 days after each vaccination.
Safety Endpoint: The Frequency of Serious Adverse Events (SAEs).
Frequency of serious adverse events (SAEs) for 180 days after the last vaccination dose.
Measured: 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
Measured: 28 days after last vaccination.
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
Measured: 28 days after last vaccination.
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
Measured: 28 days after last vaccination.
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
Measured: 28 days after last vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seqirus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Physician Seqirus, Study director, Seqirus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545543
- Sponsor's protocol ID
- CSLCT-QIV-13-02
- Status last verified
- Apr 2018
- First submitted
- 8 Sep 2015
- Last updated
- 23 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 28390934
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02545543
- Acronym / sponsor ID
- CSLCT-QIV-13-02
- Conditions
- Influenza, Human
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,278 participants (actual)
- Lead sponsor
- SeqirusIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Posted 18 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seqirus Quadrivalent Inactivated Influenza Vaccine | Experimental | Biological: Seqirus QIVThe 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). |
| Comparator Quadrivalent Influenza Vaccine | Active comparator | Biological: Comparator QIVThe comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seqirus QIVSeqirus 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. | Biological | Seqirus Quadrivalent Inactivated Influenza Vaccine |
| Comparator QIVAlso: Fluarix QuadrivalentThe 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. | Biological | Comparator Quadrivalent Influenza Vaccine |
Primary outcome
The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.
Time frame: 28 days after last vaccination.
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.
Time frame: 28 days after last vaccination.
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.
9 secondary outcomes
Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions.
Time frame: 7 days after each vaccination.
Safety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs).
Time frame: 7 days after each vaccination.
Safety Endpoint: The Frequency of Cellulitis-like Reaction.
Time frame: 28 days after each vaccination.
Safety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs).
Time frame: 28 days after each vaccination.
Safety Endpoint: The Frequency of Serious Adverse Events (SAEs).
Time frame: 180 days after the last vaccination dose.
Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit)
Time frame: 28 days after last vaccination.
Immunogenicity Endpoint: Seroconversion Rate (SCR)
Time frame: 28 days after last vaccination.
Immunogenicity Endpoint: Seroprotection Rate
Time frame: 28 days after last vaccination.
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI)
Time frame: 28 days after last vaccination.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28390934Airey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Physician Seqirus study director
Seqirus
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Seqirus QIV and Comparator QIV in people with Influenza, Human, run by Seqirus at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. (time frame: 28 days after last vaccination.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02545543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.