Influenza, HumanPhase 3NCT02214225

A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above.

A Phase 3 study testing Quadrivalent Influenza Vaccine (QIV), Trivalent Influenza Vaccine (TIV-1) and Trivalent Influenza Vaccine (TIV-2) in people with Influenza, Human, run by Seqirus at 33 sites in United States.

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

This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated quadrivalent influenza vaccine, in comparison with a US licensed 2014/2015 trivalent influenza vaccine (bioCSL TIV-1), and a trivalent influenza vaccine containing the alternate B strain (bioCSL TIV-2), in healthy… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza, Human
What is being tested?: Quadrivalent Influenza Vaccine (QIV), Trivalent Influenza Vaccine (TIV-1) and Trivalent Influenza Vaccine (TIV-2)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,484 participants
Where: 33 sitesUnited States
Study dates: Aug 2014to Apr 2015
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Males or non-pregnant females aged ≥ 18 years at the time of vaccination.
Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the On-study period. Females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine.

Who cannot join

Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of bioCSL influenza vaccines.
Vaccination against influenza in the previous 6 months.
Known history of Guillain-Barré Syndrome or other demyelinating disease.
Clinical signs of active infection and/or an oral temperature of ≥ 100.4°F (38.0°C).
A clinically significant medical condition.
Pregnant or lactating females.

Trial locations and contacts

33 sites in 1 country.

City, postcode or hospital

33 sites in 1 country

United States33 sites

Site 283
Austin, Texas, 78705
Site 316
Bellevue, Nebraska, 68005
Site 285
Binghamton, New York, 13901
Site 308
Bristol, Tennessee, 37620
Site 302
Charlotte, North Carolina, 28209
Site 303
Charlottesville, Virginia, 22911
Site 282
Forth Worth, Texas, 76135
Site 296
Huntsville, Alabama, 35802
Site 297
Jacksonville, Florida, 32207
Site 311
Jefferson City, Tennessee, 37760
Site 312
Knoxville, Tennessee, 37912
Site 304
Knoxville, Tennessee, 37938
Site 298
Las Vegas, Nevada, 89104
Site 286
Los Angeles, California, 90036
Site 293
Melbourne, Florida, 32935
Site 289
Meridian, Idaho, 83642
Site 310
Methuen, Massachusetts, 01844
Site 301
Milford, Connecticut, 06460
Site 295
Mishawaka, Indiana, 46545
Site 307
Mt. Pleasant, South Carolina, 29464
Site 299
Oklahoma City, Oklahoma, 73112
Site 294
Peoria, Illinois, 61614
Site 306
Raleigh, North Carolina, 27609
Site 313
Rochester, New York, 14642
Site 291
Rockville, Maryland, 20850
Site 300
Salt Lake City, Utah, 84124
Site 288
San Angelo, Texas, 76904
Site 315
San Diego, California, 92108
Site 292
Savannah, Georgia, 31406
Site 287
St Louis, Missouri, 63141
Site 309
Wilmington, North Carolina, 28401
Site 305
Winston-Salem, North Carolina, 27103
Site 317
Witchita, Kansas, 67207

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Multicenter, Double-blinded Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Influenza Vaccine (CSL QIV) in Comparison With a US Licensed 2014/2015 Trivalent Influenza Vaccine (CSL TIV-1), and a Trivalent Influenza Vaccine Containing the Alternate B Strain (CSL TIV-2), in Adults Aged 18 Years and Above.

Read the detailed description

This multicenter, randomized, double-blinded study was conducted during the 2014-2015 Northern Hemisphere influenza immunization season to evaluate the non-inferior immune response of bioCSL QIV to that of bioCSL TIV-1 and bioCSL TIV-2 along with safety in healthy male and female adults aged ≥ 18 years. Each vaccinated subject had a maximum 25 day on-study period with a six month safety follow-up.

Conditions: Influenza, Human
Being tested: Quadrivalent Influenza Vaccine (QIV), Trivalent Influenza Vaccine (TIV-1), Trivalent Influenza Vaccine (TIV-2)
Medical subject headings: Influenza, Human

What participants receive

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

Quadrivalent Influenza Vaccine (QIV)Biological
One 0.5 mL intramuscular dose into the deltoid muscle
Trivalent Influenza Vaccine (TIV-1)Biological
One 0.5 mL intramuscular dose into the deltoid muscle.
Trivalent Influenza Vaccine (TIV-2)Biological
One 0.5 mL intramuscular dose into the deltoid muscle.

Study groups in NCT02214225
Study group	Role	What they receive
Quadrivalent Influenza Vaccine (QIV)	Experimental	The bioCSL study vaccine is a sterile, thiomersal-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 2014/2015 influenza season). Receives: Biological: Quadrivalent Influenza Vaccine (QIV)
Trivalent Influenza Vaccine (TIV-1)	Active comparator	The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Receives: Biological: Trivalent Influenza Vaccine (TIV-1)
Trivalent Influenza Vaccine (TIV-2)	Active comparator	The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternate B strain for the Northern Hemisphere 2014/2015 influenza season). Receives: Biological: Trivalent Influenza Vaccine (TIV-2)

What is being measured

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

Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population).
Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.
Measured: 21 days after vaccination.
The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years.
SCR (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) was determined for each virus strain included in the vaccines: bioCSL TIV-1 and bioCSL TIV-2 SCRs were pooled for analysis of the A strains. The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.
Measured: 21 days after vaccination.

Secondary outcomes (12)

Postvaccination GMT (Statistical Analyses: GMT Ratios) Assessed Separately Within Each Age Group (18 Through 64 Years and ≥ 65 Years of Age) (Per-Protocol Population).
Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.
Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age) through assessment of GMT ratios as described for the primary endpoint.
Measured: 21 days after vaccination.
The Seroconversion Rate (SCR) (Statistical Analyses: Difference in SCR) for Each Virus Strain, Assessed Separately Within Each Age Group (18 to < 65 Years and ≥ 65 Years of Age) (Per Protocol Population).
Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age) through assessment of SCR differences as described for the primary endpoint.
Measured: 21 days after vaccination.
Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by the GMT (Statistical Analysis: GMT Ratio) for This Strain, Overall and by Age Cohort (Per Protocol Population).
Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.
(GMT dispersion values are based on unadjusted GMT values.)
Measured: 21 days after vaccination.
Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) for This Strain, Overall and by Age Cohort (Per Protocol Population)
Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The SCR difference was calculated as bioCSL QIV SCR minus bioCSL TIV SCR, which is the reverse of how it was calculated for the non-inferiority analyses. For the SCR comparison superiority was demonstrated if the lower limit of the two-sided 95% CI of the difference of the seroconversion rates was greater than 0 for each B strain in QIV compared with the corresponding B strain not contained in each TIV.
Measured: 21 days after vaccination.
Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination.
The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of geometric mean HI titers (GMT) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).
Measured: 21 days after vaccination.
Geometric Mean Fold Titer Change From Prevaccination to Postvaccination.
The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 assessed in terms of Geometric Mean Fold Increase (GMFI, defined as the geometric mean of the fold increases of postvaccination antibody titer over the prevaccination antibody titer) by Age Cohort (Per Protocol Population).
Measured: 21 days after vaccination.
Seroprotection Rates Prevaccination and Postvaccination.
The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of percentage of subjects with a HI titer ≥40 (seroprotection rates) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).
Measured: 21 days after vaccination.
Seroconversion Rates
The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bio CSL TIV-2 was assessed in terms of the seroconversion rate, ie, percentage 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 post-vaccination titer. Data presented in age cohorts (per protocol population).
Measured: 21 days after vaccination.
The Frequency and Severity of Solicited Local and Systemic Adverse Events (AEs).
The overall number of subjects experiencing at least one event of a local and systemic solicited AE, and the overall number of subjects with at least one severe (grade 3) local and systemic solicited AE.
Measured: For 7 days following vaccination.
The Frequency of Cellulitis-like Reaction and Cellulitis.
The number of subjects experiencing at least one episode of each event.
Measured: For 28 days following vaccination.
The Frequency and Severity of Unsolicited AEs.
The overall number of subjects experiencing at least one event of an unsolicited AE, and the overall number of subjects with at least one severe (grade 3) unsolicited AE.
Measured: For 28 days following vaccination.
The Frequency of Serious Adverse Events (SAEs) for 6 Months Following Vaccination.
The number of participants reporting Serious Adverse Events for 6 months following vaccination.
Measured: For 6 months following vaccination.

Timeline

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

Aug 2014Apr 2015

First posted12 Aug 2014 (estimated)
Study startAug 2014
Primary completionNov 2014
Study completionApr 2015

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: 3,484 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02214225
Sponsor's protocol ID: CSLCT-QIV-13-01
Status last verified: Jan 2017
First submitted: 10 Aug 2014
Last updated: 13 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Treanor JT, Albano FR, Sawlwin DC, Graves Jones A, Airey J, Formica N, Matassa V, Leong J. Immunogenicity and safety of a quadrivalent inactivated influenza vaccine compared with two trivalent inactivated influenza vaccines containing alternate B strains in adults: A phase 3, randomized noninferiority study. Vaccine. 2017 Apr 4;35(15):1856-1864. doi: 10.1016/j.vaccine.2017.02.066. Epub 2017 Mar 13.
PubMed 28302411

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

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

All Influenza, Human trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Multicenter, Double-blinded Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Influenza Vaccine (CSL QIV) in Comparison With a US Licensed 2014/2015 Trivalent Influenza Vaccine (CSL TIV-1), and a Trivalent Influenza Vaccine Containing the Alternate B Strain (CSL TIV-2), in Adults Aged 18 Years and Above.
ClinicalTrials.gov ID: NCT02214225
Acronym / sponsor ID: CSLCT-QIV-13-01
Conditions: Influenza, Human
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,484 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Nov 2014 (actual)
Study completion: Apr 2015 (actual)
First posted: 12 Aug 2014 (estimated)
Results: Posted 23 Feb 2016

Clinical summary

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Quadrivalent Influenza Vaccine (QIV)	Experimental	Biological: Quadrivalent Influenza Vaccine (QIV)The bioCSL study vaccine is a sterile, thiomersal-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 2014/2015 influenza season).
Trivalent Influenza Vaccine (TIV-1)	Active comparator	Biological: Trivalent Influenza Vaccine (TIV-1)The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
Trivalent Influenza Vaccine (TIV-2)	Active comparator	Biological: Trivalent Influenza Vaccine (TIV-2)The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternate B strain for the Northern Hemisphere 2014/2015 influenza season).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Males or non-pregnant females aged ≥ 18 years at the time of vaccination.
Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the On-study period. Females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine.

Key exclusion criteria (6 listed)

Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of bioCSL influenza vaccines.
Vaccination against influenza in the previous 6 months.
Known history of Guillain-Barré Syndrome or other demyelinating disease.
Clinical signs of active infection and/or an oral temperature of ≥ 100.4°F (38.0°C).
A clinically significant medical condition.

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
Quadrivalent Influenza Vaccine (QIV)One 0.5 mL intramuscular dose into the deltoid muscle	Biological	Quadrivalent Influenza Vaccine (QIV)
Trivalent Influenza Vaccine (TIV-1)One 0.5 mL intramuscular dose into the deltoid muscle.	Biological	Trivalent Influenza Vaccine (TIV-1)
Trivalent Influenza Vaccine (TIV-2)One 0.5 mL intramuscular dose into the deltoid muscle.	Biological	Trivalent Influenza Vaccine (TIV-2)

Primary outcome

Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population).
Time frame: 21 days after vaccination.
Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.
The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years.
Time frame: 21 days after vaccination.
SCR (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) was determined for each virus strain included in the vaccines: bioCSL TIV-1 and bioCSL TIV-2 SCRs were pooled for analysis of the A strains. The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.

12 secondary outcomes

Postvaccination GMT (Statistical Analyses: GMT Ratios) Assessed Separately Within Each Age Group (18 Through 64 Years and ≥ 65 Years of Age) (Per-Protocol Population).
Time frame: 21 days after vaccination.
The Seroconversion Rate (SCR) (Statistical Analyses: Difference in SCR) for Each Virus Strain, Assessed Separately Within Each Age Group (18 to < 65 Years and ≥ 65 Years of Age) (Per Protocol Population).
Time frame: 21 days after vaccination.
Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by the GMT (Statistical Analysis: GMT Ratio) for This Strain, Overall and by Age Cohort (Per Protocol Population).
Time frame: 21 days after vaccination.
Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) for This Strain, Overall and by Age Cohort (Per Protocol Population)
Time frame: 21 days after vaccination.
Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination.
Time frame: 21 days after vaccination.
Geometric Mean Fold Titer Change From Prevaccination to Postvaccination.
Time frame: 21 days after vaccination.
Seroprotection Rates Prevaccination and Postvaccination.
Time frame: 21 days after vaccination.
Seroconversion Rates
Time frame: 21 days after vaccination.
The Frequency and Severity of Solicited Local and Systemic Adverse Events (AEs).
Time frame: For 7 days following vaccination.
The Frequency of Cellulitis-like Reaction and Cellulitis.
Time frame: For 28 days following vaccination.
The Frequency and Severity of Unsolicited AEs.
Time frame: For 28 days following vaccination.
The Frequency of Serious Adverse Events (SAEs) for 6 Months Following Vaccination.
Time frame: For 6 months following vaccination.

Results and safety

Results posted to the registry on 23 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Quadrivalent Influenza Vaccine (QIV)	1,741	1,686
Trivalent Influenza Vaccine (TIV-1)	871	852
Trivalent Influenza Vaccine (TIV-2)	872	850

Primary outcome: Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population).

Time frame: 21 days after vaccination.. Geometric mean (Full Range). Unit: Titer

Measure	GMT: bioCSL QIV n = 1691	GMT: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC) n = 1704
A/H1N1	303.0 (5 to 8127)	280.2 (5 to 6451)
A/H3N2	488.7 (5 to 10240)	454.2 (5 to 12902)
B/Yamagata	64.3 (5 to 2560)	55.7 (5 to 2560)
B/Victoria	87.9 (5 to 2560)	82.2 (5 to 5120)

GMT: bioCSL QIV vs GMT: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC): GMT ratio (A/H1N1): 0.92 (95% CI 0.87 to 0.98)
GMT: bioCSL QIV vs GMT: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC): GMT ratio (A/H3N2): 0.93 (95% CI 0.88 to 0.98)
GMT: bioCSL QIV vs GMT: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC): GMT ratio (B/YAM): 0.87 (95% CI 0.81 to 0.93)

Population analysed: The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.

Primary outcome: The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years.

Time frame: 21 days after vaccination.. Number. Unit: percentage of participants

Measure	SCR: bioCSL QIV n = 1691	SCR: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC) n = 1704
A/H1N1	38.8	37.7
A/H3N2	40.9	39.3
B/Yamagata	31.0	27.8
B/Victoria	40.3	38.7

SCR: bioCSL QIV vs SCR: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC): Difference in SCR (A/H1N1): -1.1 (95% CI -4.4 to 2.2)
SCR: bioCSL QIV vs SCR: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC): Difference in SCR (A/H3N2): -1.7 (95% CI -5.0 to 1.6)
SCR: bioCSL QIV vs SCR: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC): Difference in SCR (B/YAM): -3.2 (95% CI -7.0 to 0.5)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Quadrivalent Influenza Vaccine (QIV)	39 of 1,721 (2.3%)	872 of 1,721 (50.7%)	Not reported
Trivalent Influenza Vaccine (TIV-1)	14 of 864 (1.6%)	445 of 864 (51.5%)	Not reported
Trivalent Influenza Vaccine (TIV-2)	13 of 864 (1.5%)	397 of 864 (45.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28302411Treanor JT, Albano FR, Sawlwin DC, Graves Jones A, Airey J, Formica N, Matassa V, Leong J. Immunogenicity and safety of a quadrivalent inactivated influenza vaccine compared with two trivalent inactivated influenza vaccines containing alternate B strains in adults: A phase 3, randomized noninferiority study. Vaccine. 2017 Apr 4;35(15):1856-1864. doi: 10.1016/j.vaccine.2017.02.066. Epub 2017 Mar 13.

Related trials for Influenza, Human

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

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.

bioCSL Pty Ltd Clinical Program Director study director

Seqirus

33 sites in 1 country: 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 6 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 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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 23 Feb 2016). 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?

Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population). (time frame: 21 days after 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 NCT02214225, 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 13 Mar 2017.