InfluenzaPhase 3NCT02255409

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

A Phase 3 study testing Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) and non-adjuvanted Quadrivalent Influenza Vaccine (QIV) in people with Influenza, run by Seqirus at 28 sites in 2 countries.

Completed

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

Official record

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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 Read more about this study

Who is it for?: Ages 12 to 84 monthsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) and non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 607 participants
Where: 28 sitesin 2 countries
Study dates: Oct 2014to Jan 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 12 to 84 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Male or female subject who has completed their Day 181 clinic visit for non-naïve subjects or their Day 209 clinic visit for naïve subjects in parent study.
Individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up

Who cannot join

Individuals recently vaccinated against influenza.
Subjects with contraindications to receive influenza vaccine.
Please contact the site for additional eligibility criteria.

Trial locations and contacts

28 sites in 2 countries.

Country

City, postcode or hospital

28 sites in 2 countries

United States19 sites

Study site
Augusta, Kansas, 67010
Study site
Austin, Texas, 78705
Study site
Bellevue, Nebraska, 68005
Study site
Binghamton, New York, 13901
Study site
Colorado Springs, Colorado, 80920
Study site
Dayton, Ohio, 45406
Study site
Fort Worth, Texas, 76135
Study site
Louisville, Kentucky, 40291
Study site
Melbourne, Florida, 32935
Study site
Metairie, Louisiana, 70006
Study site
Newton, Kansas, 67114
Study site
Salt Lake City, Utah, 84109
Study site
Salt Lake City, Utah, 84121
Study site
Salt Lake City, Utah, 84124
Study site
San Angelo, Texas, 76904
Study site
San Diego, California, 92103
Study site
San Gabriel, California, 91706
Study site
Tomball, Texas, 77375
Study site
West Jordan, Utah, 84088

Other trials in United States

Finland9 sites

Study site
Espoo, 02230
Study site
Helsinki, 00100
Study site
Helsinki, 00930
Study site
Jarvenpaa, 04400
Study site
Kokkola, 67100
Study site
Pori, 28100
Study site
Tampere, 33100
Study site
Turku, 20520
Study site
Vantaa, 01300

Other trials in Finland

About this study

Official title: A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV), Administered to Subjects Previously Vaccinated in Trial V118_05

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

Conditions: Influenza
Being tested: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV), non-adjuvanted Quadrivalent Influenza Vaccine (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.

Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)Biological
1 dose 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months
non-adjuvanted Quadrivalent Influenza Vaccine (QIV)Biological
1 dose 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months

Study groups in NCT02255409
Study group	Role	What they receive
aQIV	Experimental	Adjuvanted Quadrivalent Subunit Influenza Receives: Biological: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
QIV	Active comparator	Non-Adjuvanted Quadrivalent Subunit Influenza Receives: Biological: non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

What is being measured

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

Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs.
Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator): serious adverse events (SAEs), AEs leading to study withdrawal, new onset chronic disease (NOCDs), adverse events of special interest (AESIs) and medically attended AEs after vaccination.
Measured: Day 1 through Day 356
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22)
The percentage of subjects achieving seroconversion at Day 22 after vaccination is reported for homologous strains; Seroconversion is defined as hemagglutination inhibition (HI) ≥1:40 for subjects negative at baseline [<1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
Measured: Day 1, Day 22
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and and Differences in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 22).
The percentage of subjects achieving HI titer ≥1:40 at Day 22 after vaccination is reported for homologous strains. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
Measured: Day 1, Day 22

Secondary outcomes (11)

Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature
Short stature was defined as a height/length that was 2 or more standard deviations below the mean for age and gender within a population and was assessed as being below the 2nd z-score (worse outcome) on the length/height-for-age scale. Failure-to-thrive was defined by inadequate weight gain and physical growth and assessed through 2 or more of the following criteria: height/length-for-age, weight-for-age or weight-for-height/length below the 2nd z-score, a child's growth line crossing a z-score line, a sharp change in growth curve or a curve that remains flat. The observations were made for 2 or more time points each divided by at least 2 months.
Measured: Day 1 through Day 366 (Day 1, Day 22, Day 181, Day 366)
Safety Endpoint: Number of Subjects With Any Unsolicited AEs
Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator).
Measured: Day 1 through Day 22
Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting solicited local and systemic AEs, day 1 to day 7 after vaccination with either aQIV or QIV (comparator).
Measured: Up to 7 days following vaccination
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181)
The percentage of subjects achieving seroconversion at Day 181 after vaccination is reported for homologous strains. Seroconversion is defined as HI ≥1:40 for subjects negative at baseline [<1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab.
Measured: Day 1, Day 181
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 181)
The percentage of subjects achieving HI titer ≥1:40 at Day 181 after vaccination is reported for homologous strains; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
Measured: Day 1, Day 181
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)
Adjusted GMT, GMR and 95% confidence interval (CI) were analyzed using ANCOVA with study specific covariates. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
Measured: Day 1, Day 22, Day 181
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains
The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
Measured: Day 1, Day 22, and Day 181
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Difference in Percentage of Subjects Achieving Seroconversion for Heterologous Influenza Strains (Day 181)
The percentage of subjects achieving seroconversion at Day 181 after vaccination is reported for homologous strains. Seroconversion is defined as HI ≥1:40 for subjects negative at baseline [<1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab
Measured: Day 1, Day 181
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Heterologous Influenza Strains (Day 181)
The percentage of subjects achieving HI titer ≥1:40 at Day 181 after vaccination is reported for homologous strains; Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab
Measured: Day 1, Day 181
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181)
Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab
Measured: Day 1, Day 22, Day 181
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains
The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab
Measured: Day 1, Day 22, and Day 181

Timeline

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

Oct 2014Jan 2016

First posted2 Oct 2014 (estimated)
Study startOct 2014
Primary completionJan 2016
Study completionJan 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.
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: Single blind
Who is masked: Participant
Enrolment: 607 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02255409
Sponsor's protocol ID: V118_05E1
Other IDs: 2014-002599-95, 2014
Status last verified: Mar 2023
First submitted: 25 Sep 2014
Last updated: 15 Mar 2023
Results posted: Yes, on ClinicalTrials.gov

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2023. 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 an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV), Administered to Subjects Previously Vaccinated in Trial V118_05
ClinicalTrials.gov ID: NCT02255409
Acronym / sponsor ID: V118_05E1
Conditions: Influenza
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 607 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Jan 2016 (actual)
Study completion: Jan 2016 (actual)
First posted: 2 Oct 2014 (estimated)
Results: Posted 15 Mar 2023

Clinical summary

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

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
aQIV	Experimental	Biological: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)Adjuvanted Quadrivalent Subunit Influenza
QIV	Active comparator	Biological: non-adjuvanted Quadrivalent Influenza Vaccine (QIV)Non-Adjuvanted Quadrivalent Subunit Influenza

Who may qualify

Ages: 12 to 84 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Male or female subject who has completed their Day 181 clinic visit for non-naïve subjects or their Day 209 clinic visit for naïve subjects in parent study.
Individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up

Key exclusion criteria (3 listed)

Individuals recently vaccinated against influenza.
Subjects with contraindications to receive influenza vaccine.
Please contact the site for additional eligibility criteria.

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 Quadrivalent Subunit Influenza Virus Vaccine (aQIV)1 dose 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months	Biological	aQIV
non-adjuvanted Quadrivalent Influenza Vaccine (QIV)1 dose 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months	Biological	QIV

Primary outcome

Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs.
Time frame: Day 1 through Day 356
Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator): serious adverse events (SAEs), AEs leading to study withdrawal, new onset chronic disease (NOCDs), adverse events of special interest (AESIs) and medically attended AEs after vaccination.
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22)
Time frame: Day 1, Day 22
The percentage of subjects achieving seroconversion at Day 22 after vaccination is reported for homologous strains; Seroconversion is defined as hemagglutination inhibition (HI) ≥1:40 for subjects negative at baseline [<1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and and Differences in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 22).
Time frame: Day 1, Day 22
The percentage of subjects achieving HI titer ≥1:40 at Day 22 after vaccination is reported for homologous strains. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab

11 secondary outcomes

Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature
Time frame: Day 1 through Day 366 (Day 1, Day 22, Day 181, Day 366)
Safety Endpoint: Number of Subjects With Any Unsolicited AEs
Time frame: Day 1 through Day 22
Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Time frame: Up to 7 days following vaccination
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181)
Time frame: Day 1, Day 181
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 181)
Time frame: Day 1, Day 181
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)
Time frame: Day 1, Day 22, Day 181
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains
Time frame: Day 1, Day 22, and Day 181
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Difference in Percentage of Subjects Achieving Seroconversion for Heterologous Influenza Strains (Day 181)
Time frame: Day 1, Day 181
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Heterologous Influenza Strains (Day 181)
Time frame: Day 1, Day 181
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181)
Time frame: Day 1, Day 22, Day 181
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains
Time frame: Day 1, Day 22, and Day 181

Results and safety

Results posted to the registry on 15 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adjuvanted Quadrivalent Influenza Vaccine (aQIV)	318	304
Comparator Quadrivalent Influenza Vaccine (QIV)	289	258

Primary outcome: Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs.

Time frame: Day 1 through Day 356. Count of participants. Unit: Participants

Measure	aQIV n = 317	Comparator QIV n = 288
SAEs	7	4
At least possibly related SAEs	0	0
NOCDs	13	7
AESIs	1	1
Medically attended AEs	161	141
AEs leading to withdrawal	0	0

Population analysed: The Unsolicited Safety Set consisting of subjects who received a study vaccination and who had any AE assessments (ie, a subject did not have to have an AE to be included in this population) was used for analysis.

Primary outcome: Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22)

Time frame: Day 1, Day 22. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	aQIV n = 302	Comparator QIV n = 257
A/H1N1	57.9 (52.2 to 63.6)	56.4 (50.1 to 62.6)
A/H3N2	50.7 (44.9 to 56.4)	56.6 (50.3 to 62.8)
B/Yamagata	73.5 (68.2 to 78.4)	57.2 (50.9 to 63.3)
B/Victoria	72.2 (66.8 to 77.2)	58.0 (51.7 to 64.1)

aQIV vs Comparator QIV: Mean Difference (Final Values): 1.5 (95% CI -6.7 to 9.7)
aQIV vs Comparator QIV: Mean Difference (Final Values): -6.0 (95% CI -14.2 to 2.3)
aQIV vs Comparator QIV: Mean Difference (Final Values): 16.3 (95% CI 8.4 to 24.1)

Population analysed: The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181). Day 22 analyses are reported for the 302 and 257 (256 for the A/H3N2 strain) participants in the aQIV and Comparator QIV groups, respectively, who had immunogenicity data at both Day 1 and Day 22.

Primary outcome: Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and and Differences in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 22).

Time frame: Day 1, Day 22. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	Adjuvanted Quadrivalent Influenza Vaccine (aQIV) n = 302	Comparator Quadrivalent Influenza Vaccine (QIV) n = 257
A/H1N1, Homologous	100.0 (98.8 to 100.0)	99.6 (97.9 to 100.0)
A/H3N2, Homologous	99.7 (98.2 to 100.0)	100.0 (98.6 to 100.0)
B/Yamagata, Homologous	95.7 (92.8 to 97.7)	81.3 (76.0 to 85.9)
B/Victoria, Homologous	98.0 (95.7 to 99.3)	72.0 (66.1 to 77.4)

Adjuvanted Quadrivalent Influenza Vaccine (aQIV) vs Comparator Quadrivalent Influenza Vaccine (QIV): Mean Difference (Final Values): 0.4 (95% CI -0.9 to 2.2)
Adjuvanted Quadrivalent Influenza Vaccine (aQIV) vs Comparator Quadrivalent Influenza Vaccine (QIV): Mean Difference (Final Values): -0.3 (95% CI -1.9 to 1.2)
Adjuvanted Quadrivalent Influenza Vaccine (aQIV) vs Comparator Quadrivalent Influenza Vaccine (QIV): Mean Difference (Final Values): 14.4 (95% CI 9.3 to 20.0)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
aQIV	7 of 317 (2.2%)	253 of 317 (79.8%)	0 of 317
Comparator QIV	4 of 288 (1.4%)	210 of 290 (72.4%)	0 of 290

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

28 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 3 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States, Finland. 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 15 Mar 2023). 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?

Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs. (time frame: Day 1 through Day 356). The study lists 3 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 NCT02255409.

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 15 Mar 2023.