InfluenzaPhase 3NCT01992094

Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older

A Phase 3 study testing QIVc, TIV1c and TIV2c in people with Influenza, run by Novartis Vaccines at 40 sites in United States.

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

Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and above. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Influenza
What is being tested?: QIVc, TIV1c and TIV2c
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,680 participants
Where: 40 sitesUnited States
Study dates: Nov 2013to Jul 2014
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female ages 18 years and older.
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

40 sites in 1 country.

City, postcode or hospital

40 sites in 1 country

United States40 sites

Study site
Anaheim, California, 92801
Study site
Anderson, South Carolina, 29621
Study site
Austin, Texas, 78705
Study site
Austin, Texas, 78745
Study site
Bellevue, Nebraska, 68005
Study site
Cary, North Carolina, 27518
Study site
Charlotte, North Carolina, 28209
Study site
Coral Gables, Florida, 33134
Study site
Council Bluffs, Iowa, 51503
Study site
Dakota Dunes, South Dakota, 57049
Study site
Dallas, Texas, 75231
Study site
Edina, Minnesota, 55435
Study site
Endwell, New York, 13760
Study site
Fort Worth, Texas, 76135
Study site
Hollywood, Florida, 33024
Study site
Huntsville, Alabama, 35802
Study site
Melbourne, Florida, 32935
Study site
Metairie, Louisiana, 70006
Study site
Mishawaka, Indiana, 46545
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Newton, Kansas, 67114
Study site
Oklahoma City, Oklahoma, 73112
Study site
Omaha, Nebraska, 68134
Study site
Peoria, Illinois, 61602
Study site
Phoenix, Arizona, 85050
Study site
Raleigh, North Carolina, 27609
Study site
Rochester, New York, 14609
Study site
Rockville, Maryland, 20850
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, 92108
Study site
South Jordan, Utah, 84095
Study site
South Miami, Florida, 33143
Study site
Warwick, Rhode Island, 02886
Study site
West Palm Beach, Florida, 33409
Study site
Wichita, Kansas, 67205
Study site
Wichita, Kansas, 67207
Study site
Wilmington, North Carolina, 28401

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About this study

Official title: A Phase III, Stratified, Randomized, Double-Blind, Multicenter, NonInferiority Study to Evaluate the Safety and Immunogenicity of a Cell-based Quadrivalent Subunit Influenza Virus Vaccine and Cell-based Trivalent Subunit Influenza Virus Vaccines in Adults Ages ≥18 Years of Age

Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and above.

Conditions: Influenza
Being tested: QIVc, TIV1c, TIV2c
Keywords: Influenza, Influenza vaccine, Novartis, Adults
Medical subject headings: Influenza, Human

What participants receive

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

QIVcBiological
Novartis Investigational Quadrivalent Vaccine
TIV1cBiological
Licensed Influenza Vaccine
TIV2cBiological
Novartis Investigational Vaccine

Study groups in NCT01992094
Study group	Role	What they receive
QIVc	Experimental	Influenza vaccine Receives: Biological: QIVc
TIV1c	Active comparator	Influenza vaccine Receives: Biological: TIV1c
TIV2c	Active comparator	Influenza vaccine Receives: Biological: TIV2c

What is being measured

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

1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of GMT in subjects measured by hemagglutination inhibition (HI) assay, three weeks after vaccination with one dose of either QIVc or TIV1c and TIV2c.
Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5.
Measured: Three weeks post vaccination (Day 22)
2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c
Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with one dose of either QIVc,TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer
Measured: Three weeks post vaccination (Day 22)

Secondary outcomes (11)

3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts
Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against each vaccine strains, three weeks (day 22) after vaccination with ether QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% and that for the ≥ 65 years age group should meet or exceed 30%
Measured: Three weeks post vaccination (Day 22)
4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts
Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70% and that for the ≥ 65 years age group should meet or exceed 60%
Measured: Three weeks post vaccination (Day 22)
5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of post-vaccination to pre-vaccination HI GMTs, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Committee for Medicinal Products for Human Use (CHMP) criterion for 18 to ≤60 years age group is >2.5 and that for ≥ 61 years age group is >2.0
Measured: Three weeks post vaccination (Day 22)
6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving seroconversion or significant increase in HI titer is >40% and that for ≥ 61 years age group is >30%
Measured: Three weeks post vaccination (Day 22)
7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c and TIV2c The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving an HI titer ≥1:40 is >70% and that for ≥ 61 years age group is >60%
Measured: Three weeks post vaccination (Day 22)
8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain
Immunogenicity of QIVc to TIV1c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV1c.
Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1.
Measured: Three weeks post vaccination (Day 22)
9.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c Against B2 Strain
Immunogenicity of QIVc to TIV1c was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks (day 22) after vaccination with QIVc or TIV1c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points
Measured: Three weeks post vaccination (Day 22)
10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain
Immunogenicity of QIVc to TIV2c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV2c.
Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1
Measured: Three weeks post vaccination (Day 22)
11.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV2c Against B1 Strain
Immunogenicity of QIVc to TIV2c in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks (day 22) after vaccination with QIVc or TIV2c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points
Measured: Three weeks post vaccination (Day 22)
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Safety was assessed in terms of number (%) of subjects reporting solicited local and systemic reactions, day 1 to 7 after vaccination with one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)
Measured: Day 1 to 7 post vaccination
13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Safety was assessed in terms of number (%) of subjects reporting unsolicited AEs (day 1 to 22 after vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 post vaccination) after receiving one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)
Measured: Day 1 to 181 post vaccination

Timeline

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

Nov 2013Jul 2014

First posted25 Nov 2013 (estimated)
Study startNov 2013
Primary completionJul 2014
Study completionJul 2014

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: 2,680 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01992094
Sponsor's protocol ID: V130_01
Status last verified: Nov 2015
First submitted: 7 Nov 2013
Last updated: 10 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Stratified, Randomized, Double-Blind, Multicenter, NonInferiority Study to Evaluate the Safety and Immunogenicity of a Cell-based Quadrivalent Subunit Influenza Virus Vaccine and Cell-based Trivalent Subunit Influenza Virus Vaccines in Adults Ages ≥18 Years of Age
ClinicalTrials.gov ID: NCT01992094
Acronym / sponsor ID: V130_01
Conditions: Influenza
Keywords: Influenza, Influenza vaccine, Novartis, Adults
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,680 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 25 Nov 2013 (estimated)
Results: Posted 10 Dec 2015

Clinical summary

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

Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and above.

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
QIVc	Experimental	Biological: QIVcInfluenza vaccine
TIV1c	Active comparator	Biological: TIV1cInfluenza vaccine
TIV2c	Active comparator	Biological: TIV2cInfluenza vaccine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male or female ages 18 years and older.
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
QIVcNovartis Investigational Quadrivalent Vaccine	Biological	QIVc
TIV1cLicensed Influenza Vaccine	Biological	TIV1c
TIV2cNovartis Investigational Vaccine	Biological	TIV2c

Primary outcome

1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
Time frame: Three weeks post vaccination (Day 22)
Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of GMT in subjects measured by hemagglutination inhibition (HI) assay, three weeks after vaccination with one dose of either QIVc or TIV1c and TIV2c. Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5.
2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c
Time frame: Three weeks post vaccination (Day 22)
Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with one dose of either QIVc,TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer

11 secondary outcomes

3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts
Time frame: Three weeks post vaccination (Day 22)
4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts
Time frame: Three weeks post vaccination (Day 22)
5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
Time frame: Three weeks post vaccination (Day 22)
6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
Time frame: Three weeks post vaccination (Day 22)
7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
Time frame: Three weeks post vaccination (Day 22)
8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain
Time frame: Three weeks post vaccination (Day 22)
9.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c Against B2 Strain
Time frame: Three weeks post vaccination (Day 22)
10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain
Time frame: Three weeks post vaccination (Day 22)
11.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV2c Against B1 Strain
Time frame: Three weeks post vaccination (Day 22)
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Time frame: Day 1 to 7 post vaccination
13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Time frame: Day 1 to 181 post vaccination

Results and safety

Results posted to the registry on 10 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
QIVc (≥18 Years)	1,335	1,285
TIV1c (≥18 Years)	676	652
TIV2c (≥18 Years)	669	648

Primary outcome: 1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c

Time frame: Three weeks post vaccination (Day 22). Geometric mean (95% Confidence Interval). Unit: Titer

Measure	QIVc (≥18 Years) n = 1335	TIV1c (≥18 Years) n = 676	TIV2c (≥18 Years) n = 669
H1N1: Day 1(N=1250,635,NA)	60.7 (56.0 to 65.9)	59.6 (53.0 to 67.0)	NA (NA to NA)
H1N1: Day 22(N=1250,635,NA)	302.8 (281.8 to 325.5)	298.9 (270.3 to 330.5)	NA (NA to NA)
H3N2: Day 1(N=1250,635,NA)	122.5 (112.7 to 133.1)	128.1 (113.6 to 144.6)	NA (NA to NA)
H3N2: Day 22(N=1250,635,NA)	372.3 (349.2 to 396.9)	378.4 (345.1 to 414.8)	NA (NA to NA)
B1:Day 1(N=1250,635,NA)	45.3 (42.6 to 48.1)	43.8 (40.2 to 47.7)	NA (NA to NA)
B1:Day 22(N=1250,635,NA)	133.2 (125.3 to 141.7)	115.6 (106.4 to 125.6)	NA (NA to NA)
B2:Day 1(N=1250,NA,639)	59.2 (56.0 to 62.7)	NA (NA to NA)	58.0 (53.4 to 63.0)
B2:Day 22(N=1250,NA,639)	177.2 (167.6 to 187.5)	NA (NA to NA)	164.0 (151.4 to 177.7)

QIVc (≥18 Years) vs TIV1c (≥18 Years): Ratios of GMT: 1.0 (95% CI 0.9 to 1.1), ANCOVA
QIVc (≥18 Years) vs TIV1c (≥18 Years): Ratios of GMT: 1.0 (95% CI 0.9 to 1.1), ANCOVA
QIVc (≥18 Years) vs TIV1c (≥18 Years): Ratios of GMT: 0.9 (95% CI 0.8 to 1.0), ANCOVA

Population analysed: Analysis was done on Per Protocol (PP) Population i.e. all subjects in the Full Analysis Set (FAS) efficacy/immunogenicity population correctly receive the vaccine, have no major protocol deviations leading to exclusion as defined prior to unblinding/analysis and are not excluded due to other reasons defined prior to unblinding or analysis

Primary outcome: 2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c

Time frame: Three weeks post vaccination (Day 22). Number (95% Confidence Interval). Unit: percentage of subjects

Measure	QIVc (≥18 Years) n = 1335	TIV1c (≥18 Years) n = 676	TIV2c (≥18 Years) n = 669
H1N1: Day 22(N=1250, 635,NA)	49.2 (46.4 to 52.0)	48.7 (44.7 to 52.6)	NA (NA to NA)
H3N2: Day 22(N=1250, 635,NA)	38.3 (35.6 to 41.1)	35.6 (31.9 to 39.5)	NA (NA to NA)
B1: Day 22(N=1250, 635,NA)	36.6 (33.9 to 39.3)	34.8 (31.1 to 38.7)	NA (NA to NA)
B2: Day 22(N=1250,NA, 639)	39.8 (37.0 to 42.5)	NA (NA to NA)	35.4 (31.7 to 39.2)

QIVc (≥18 Years) vs TIV1c (≥18 Years): Difference between seroconversion rates: -0.5 (95% CI -5.3 to 4.2), ANCOVA
QIVc (≥18 Years) vs TIV1c (≥18 Years): Difference between seroconversion rates: -2.7 (95% CI -7.2 to 1.9), ANCOVA
QIVc (≥18 Years) vs TIV1c (≥18 Years): Difference between seroconversion rates: -1.8 (95% CI -6.2 to 2.8), ANCOVA

Population analysed: Analysis was done on PP population

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
QIVc (≥18 Years)	52 of 1,324 (3.9%)	681 of 1,324 (51.4%)	Not reported
TIV1c (≥ 18 Years)	22 of 673 (3.3%)	332 of 673 (49.3%)	Not reported
TIV2c (≥18 Years)	21 of 665 (3.2%)	335 of 665 (50.4%)	Not reported
Total	95 of 2,662 (3.6%)	1,348 of 2,662 (50.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
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.

Novartis Vaccines study chair

Novartis Vaccines

40 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 QIVc, TIV1c and TIV2c in people with Influenza, run by Novartis Vaccines at 40 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 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 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 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 10 Dec 2015). 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?

1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c (time frame: Three weeks post vaccination (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 NCT01992094.

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 10 Dec 2015.