InfluenzaPhase 3NCT02583256

Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine in Children Previously Vaccinated in Trial V118_05 (NCT01964989)

A Phase 3 study testing Adjuvanted QIV (aQIV) and Non-adjuvanted QIV in people with Influenza, run by Seqirus at 17 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously vaccinated in Trial V118_05. Subjects will receive either the Same or Alternate Type of Vaccine. Read more about this study

Who is it for?: Ages 12 months to 7 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Adjuvanted QIV (aQIV) and Non-adjuvanted QIV
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,601 participants
Where: 17 sitesin 3 countries
Study dates: 29 Jan 2016to 9 May 2017
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 12 months to 7 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
Subject's parent/legal guardian has voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
Male or female subject who has completed their Visit 13 (Study Day 366 for non-naïve subjects) or clinic Visit 15 (Day 390 for naïve subjects) in parent trial V118_05.
For naïve subjects in parent trial V118_05 to have received two doses of the same study vaccine (i.e. 2 doses of aQIV or 2 doses of QIV).

Who cannot join

Previous immunization with any influenza vaccine (licensed or investigational) within 6 months prior to enrollment.
Subjects with a clinical condition representing a contraindication to intramuscular vaccination or blood draws.
Unwillingness of the parent(s)/ legal guardian(s) of the subject to refuse to participate in another clinical trial while enrolled in V118-05E3.
Additional eligibility criteria may be discussed by contacting the site.

Trial locations and contacts

17 sites in 3 countries.

Country

City, postcode or hospital

17 sites in 3 countries

Finland9 sites

Investigational Site- 001
Espoo, Etelä-Suomen Lääni, 02230
Investigational Site- 002
Helsinki, Etelä-Suomen Lääni, 00100
Investigational Site- 003
Helsinki, Etelä-Suomen Lääni, 00100
Investigational Site- 004
Jarvenpaa, Etelä-Suomen Lääni, 04400
Investigational Site- 005
Kokkola, Länsi-Suomen Lääni, 67100
Investigational Site- 006
Oulu, 90220
Investigational Site- 007
Pori, Länsi-Suomen Lääni, 28100
Investigational Site- 009
Tampere, Länsi-Suomen Lääni, 33100
Investigational Site- 010
Turku, Länsi-Suomen Lääni, 20520

Other trials in Finland

Philippines4 sites

Investigational Site- 306
Cavite, 4114
Investigational Site- 303
Laguna, Matro Manila, 1781
Investigational Site- 304
Muntinlupa, National Capital Region, 1781
Investigational Site- 305
Muntinlupa, National Capital Region, 1781

Other trials in Philippines

Thailand4 sites

Investigational Site- 320
Bangkok, Changwat Samut Prakan, 10400
Investigational Site- 327
Bangkok, Krung Thep Maha Nakhon [Bangko, 10400
Investigational Site- 323
Bangkok, 10330
Investigational Site- 325
Pathum Thani, Bangkok, 12120

Other trials in Thailand

About this study

Official title: A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to Either the Same or Alternate Type of Vaccine, Adjuvanted or Non-adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV or QIV), Administered to Subjects Previously Vaccinated in Trial V118_05 (NCT01964989)

Conditions: Influenza
Being tested: Adjuvanted QIV (aQIV), Non-adjuvanted QIV
Keywords: Influenza Vaccine, MF59 adjuvant
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Adjuvanted QIV (aQIV)Biological
Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
Non-adjuvanted QIVBiological
Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Study groups in NCT02583256
Study group	Role	What they receive
aQIV/aQIV	Experimental	Subjects previously vaccinated with aQIV followed one year later by aQIV Receives: Biological: Adjuvanted QIV (aQIV)
aQIV/QIV	Experimental	Subjects previously vaccinated with aQIV followed one year later by QIV Receives: Biological: Non-adjuvanted QIV
QIV/aQIV	Experimental	Subjects previously vaccinated with QIV followed one year later by aQIV Receives: Biological: Adjuvanted QIV (aQIV)
QIV/QIV	Experimental	Subjects previously vaccinated with QIV followed one year later by QIV Receives: Biological: Non-adjuvanted QIV

What is being measured

The primary outcome is the main question the study is designed to answer.

Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis
GMT and 95% confidence interval (CI) were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Measured: Day 22
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis
GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Measured: Day 22

Secondary outcomes (20)

Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison)
GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Measured: Day 22
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
GMT and 95% CI were analyzed for Day 181 against homologous strains using ANCOVA with study specific covariates.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Measured: Day 181
Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
The percentage of subjects achieving seroconversion at Day 22 after vaccination is reported against homologous strains. Seroconversion was defined in subjects seronegative at baseline (i.e. HI titer <1:10 on Day 1) as postvaccination HI titer ≥1:40 and defined in subjects seropositive at baseline (i.e. HI titer ≥1:10 on Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Measured: Day 1, Day 22
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains
The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed against homologous strains using ANCOVA with study specific covariates.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Measured: Day 22, Day 181
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains
The percentage of subjects achieving HI titer ≥1:40 at Day 22 and Day 181 after vaccination is reported against homologous strains.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Measured: Day 22, Day 181
Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains
The percentage of subjects achieving HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 at Day 22 after vaccination is reported against homologous strains.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Measured: Day 22
Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains
GMT and 95% CI were analyzed for Day 22 for the heterologous strains using ANCOVA with study specific covariates.
The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B/ Victoria lineage strain, B/Malaysia/2506/2004.
Measured: Day 1, Day 22, Day 181
Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains
The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed for the heterologous strains using ANCOVA with study specific covariates.
The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B Victoria lineage strain, B/Malaysia/2506/2004.
Measured: Day 22/Day 1 and Day 181/Day 1
Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains
The percentage of subjects achieving HI titer ≥1:40 at Day 22 and Day 181 after vaccination and the percentage of subject who experienced seroconversion is reported for homologous strains. Seroconversion was defined in subjects seronegative at baseline (i.e. HI titer <1:10 on Day 1) as post-vaccination HI titer ≥1:40 and defined in subjects seropositive at baseline (i.e. HI titer ≥1:10 on Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.
The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B/Victoria lineage strain, B/Malaysia/2506/2004.
Measured: Day 22, Day 181
Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
To further characterize immune response, MN GMT and 95% CI were analyzed for Day 1, Day 22, and Day 181 against homologous strains.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Measured: Day 1, Day 22, Day 181
Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
The GMR is the geometric mean of the fold increase in MN titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed for the homologous strains using ANCOVA with study specific covariates.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Measured: Day 22/Day 1 and Day 181/Day 1
Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
To further characterize immune response, adjusted anti-NA GMT and 95% CI were analyzed for Day 1, Day 22, and Day 181 against homologous strains.
Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Measured: Day 1, Day 22, Day 181
Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
The GMR is the geometric mean of the fold increase in anti-NA titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed against homologous strains using ANCOVA with study specific covariates.
Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Measured: Day 22/Day 1 and Day 181/Day 1
Safety Endpoint: Percentage of Subjects With Solicited AEs
Safety of revaccination was assessed in terms of percentage of subjects reporting solicited AEs up to 7 days after vaccination.
Measured: Day 1 to Day 7 after vaccination
Safety Endpoint: Percentage of Subjects With Unsolicited AEs
Safety of revaccination was assessed in terms of percentage of subjects reporting unsolicited AEs during the overall study period (Day 1 to Day 366).
Measured: Day 1 to Day 366
Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE.
Safety of revaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCD, AESI and medically attended AE. Each subject was followed for a period of 12 months after receipt of the study vaccine.
NOCDs include AEs that represents a new diagnosis of a chronic medical condition that was not present or suspected in a subject prior to study enrollment. AESIs include potentially immune-mediated disorders which were reported by the investigators.
Measured: Day 1 to Day 366
Safety Endpoint: Percentage of Subjects With Diagnosis of Failure to Thrive or Short Stature
Safety of revaccination was assessed in terms of percentage of subjects reporting diagnosis of failure to thrive or short stature up to 12 months after last vaccination.
Measured: Day 1 to Day 366
Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness
Safety of revaccination was assessed in terms of percentage of subjects reporting otitis media, or pneumonia, or influenza-like illness up to 12 months after last vaccination.
Measured: Day 1 to Day 366
Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains
The percentage of subjects achieving MN titer ≥1:20, ≥1:40, ≥1:80 ≥1:160, ≥1:320 and ≥1:640 at Day 22 and Day 181 after vaccination is reported against homologous strains.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Measured: Day 22, Day 181
Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains
The percentage of subjects achieving anti-NA titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 after vaccination is reported against homologous strains
Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Measured: Day 22, Day 181

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jan 20169 May 2017

First posted22 Oct 2015 (estimated)
Study start29 Jan 2016
Primary completion15 Nov 2016
Study completion9 May 2017

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.
Other trials for InfluenzaStudies 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: 1,601 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02583256
Sponsor's protocol ID: V118_05E3
Other IDs: 2015-002973-39, 2015
Status last verified: Apr 2019
First submitted: 16 Oct 2015
Last updated: 24 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to Either the Same or Alternate Type of Vaccine, Adjuvanted or Non-adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV or QIV), Administered to Subjects Previously Vaccinated in Trial V118_05 (NCT01964989)
ClinicalTrials.gov ID: NCT02583256
Acronym / sponsor ID: V118_05E3
Conditions: Influenza
Keywords: Influenza Vaccine, MF59 adjuvant
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,601 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Study start: 29 Jan 2016 (actual)
Primary completion: 15 Nov 2016 (actual)
Study completion: 9 May 2017 (actual)
First posted: 22 Oct 2015 (estimated)
Results: Posted 24 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
aQIV/aQIV	Experimental	Biological: Adjuvanted QIV (aQIV)Subjects previously vaccinated with aQIV followed one year later by aQIV
aQIV/QIV	Experimental	Biological: Non-adjuvanted QIVSubjects previously vaccinated with aQIV followed one year later by QIV
QIV/aQIV	Experimental	Biological: Adjuvanted QIV (aQIV)Subjects previously vaccinated with QIV followed one year later by aQIV
QIV/QIV	Experimental	Biological: Non-adjuvanted QIVSubjects previously vaccinated with QIV followed one year later by QIV

Who may qualify

Ages: 12 months to 7 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
Subject's parent/legal guardian has voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
Male or female subject who has completed their Visit 13 (Study Day 366 for non-naïve subjects) or clinic Visit 15 (Day 390 for naïve subjects) in parent trial V118_05.
For naïve subjects in parent trial V118_05 to have received two doses of the same study vaccine (i.e. 2 doses of aQIV or 2 doses of QIV).

Key exclusion criteria (4 listed)

Previous immunization with any influenza vaccine (licensed or investigational) within 6 months prior to enrollment.
Subjects with a clinical condition representing a contraindication to intramuscular vaccination or blood draws.
Unwillingness of the parent(s)/ legal guardian(s) of the subject to refuse to participate in another clinical trial while enrolled in V118-05E3.
Additional eligibility criteria may be discussed by contacting the site.

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
Adjuvanted QIV (aQIV)Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)	Biological	QIV/aQIV, aQIV/aQIV
Non-adjuvanted QIVNon-adjuvanted Quadrivalent Influenza Vaccine (QIV)	Biological	QIV/QIV, aQIV/QIV

Primary outcome

Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis
Time frame: Day 22
GMT and 95% confidence interval (CI) were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis
Time frame: Day 22
GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.

20 secondary outcomes

Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison)
Time frame: Day 22
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
Time frame: Day 181
Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
Time frame: Day 1, Day 22
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains
Time frame: Day 22, Day 181
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains
Time frame: Day 22, Day 181
Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains
Time frame: Day 22
Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains
Time frame: Day 1, Day 22, Day 181
Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains
Time frame: Day 22/Day 1 and Day 181/Day 1
Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains
Time frame: Day 22, Day 181
Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
Time frame: Day 1, Day 22, Day 181
Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
Time frame: Day 22/Day 1 and Day 181/Day 1
Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
Time frame: Day 1, Day 22, Day 181
Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
Time frame: Day 22/Day 1 and Day 181/Day 1
Safety Endpoint: Percentage of Subjects With Solicited AEs
Time frame: Day 1 to Day 7 after vaccination
Safety Endpoint: Percentage of Subjects With Unsolicited AEs
Time frame: Day 1 to Day 366
Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE.
Time frame: Day 1 to Day 366
Safety Endpoint: Percentage of Subjects With Diagnosis of Failure to Thrive or Short Stature
Time frame: Day 1 to Day 366
Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness
Time frame: Day 1 to Day 366
Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains
Time frame: Day 22, Day 181
Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains
Time frame: Day 22, Day 181

Results and safety

Results posted to the registry on 24 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
aQIV/aQIV	403	400
aQIV/QIV	403	401
QIV/aQIV	402	400
QIV/QIV	393	390

Primary outcome: Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis

Time frame: Day 22. Geometric mean (95% Confidence Interval). Unit: titer

Measure	aQIV/aQIV n = 403	aQIV/QIV n = 398
A/H1N1	1219.00 (1137.35 to 1306.52)	1020.89 (953.22 to 1093.36)
A/H3N2	2355.52 (2226.19 to 2492.35)	2529.83 (2392.90 to 2674.59)
B/Yamagata	276.23 (252.73 to 301.92)	232.82 (213.25 to 254.19)
B/Victoria	388.35 (355.33 to 424.44)	328.42 (300.76 to 358.63)

aQIV/aQIV vs aQIV/QIV: GMT ratio: 1.19 (95% CI 1.1 to 1.3)
aQIV/aQIV vs aQIV/QIV: GMT ratio: 0.93 (95% CI 0.9 to 1.0)
aQIV/aQIV vs aQIV/QIV: GMT ratio: 1.19 (95% CI 1.1 to 1.3)

Population analysed: Immunogenicity per protocol set (PPS) consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop reverse transcription polymerase chain reaction(RT-PCR) confirmed influenza infection between baseline and Visit 2.

Primary outcome: Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis

Time frame: Day 22. Geometric mean (95% Confidence Interval). Unit: titer

Measure	aQIV/aQIV n = 403	aQIV/QIV n = 403
A/H1N1	1218.91 (1137.02 to 1306.70)	1023.37 (955.72 to 1095.81)
A/H3N2	2345.71 (2216.84 to 2482.07)	2521.60 (2385.43 to 2665.56)
B/Yamagata	274.75 (251.09 to 300.65)	230.51 (210.97 to 251.86)
B/Victoria	387.35 (354.15 to 423.66)	326.68 (299.10 to 356.81)

aQIV/aQIV vs aQIV/QIV: GMT ratio: 1.19 (95% CI 1.1 to 1.3)
aQIV/aQIV vs aQIV/QIV: GMT ratio: 0.93 (95% CI 0.9 to 1.0)
aQIV/aQIV vs aQIV/QIV: GMT ratio: 1.19 (95% CI 1.1 to 1.3)

Population analysed: The immunogenicity full analysis set (FAS) consisting of all subjects who received a study vaccination and provided immunogenicity data at both Visit 1 (baseline) and at least one post-vaccination visit.

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 - Day 366. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
aQIV-aQIV	10 of 403 (2.5%)	289 of 403 (71.7%)	0 of 403
aQIV-QIV	11 of 403 (2.7%)	269 of 403 (66.7%)	0 of 403
QIV-aQIV	7 of 402 (1.7%)	274 of 402 (68.2%)	0 of 402
QIV-QIV	8 of 393 (2%)	229 of 393 (58.3%)	0 of 393

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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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 Program Director study director

Seqirus

17 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adjuvanted QIV (aQIV) and Non-adjuvanted QIV in people with Influenza, run by Seqirus at 17 sites in 3 countries.

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 4 inclusion and 4 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 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Finland, Philippines, Thailand. 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 24 Apr 2019). 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?

Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis (time frame: Day 22). 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 NCT02583256.

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 24 Apr 2019.