Human InfluenzaPhase 3NCT01885117

Safety and Immunogenicity of One Dose of Seasonal Trivalent Influenza Virus Vaccine (TIVf, Purified Surface Antigen, Inactivated, Egg Derived) in Adults, Aged 18 Years and Above

A Phase 3 study testing TIVf in people with Human Influenza, run by Novartis Vaccines at 1 site in Germany.

Completed

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

Trial summary

The present study is designed to confirm the safety and immunogenicity of trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years and the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) or Hemagglutination Inhibition… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Human Influenza
What is being tested?: TIVf
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 125 participants
Where: 1 siteGermany
Study dates: Aug 2013to Sep 2013
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

Male or female volunteer aged 18 years or older, mentally competent, who gave written informed consent prior to study entry;
Able to comply with all the study requirements; and
In good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator

Who cannot join

Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may have interfered with the subject's ability to participate in the study;
any serious chronic or acute disease (in the judgment of the investigator) including, but not limited to
medically significant cancer (except for benign or localized skin cancer, cancer in remission for ≥10 years, or localized prostate cancer that has been clinically stable for >2 years without treatment)
medically significant advanced congestive heart failure (ie, New York Heart Association (NYHA) class III and IV)
chronic obstructive pulmonary disease (ie, Global initiative for chronic Obstructive Lung Disease (GOLD) stage III and IV)
autoimmune disease (including rheumatoid arthritis and excepting Hashimoto's thyroiditis that had been clinically stable for ≥5 years)

Show all 33Show fewer

diabetes mellitus type I
poorly controlled diabetes mellitus type II
advanced arteriosclerotic disease
history of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (Down's syndrome), acute or progressive hepatic disease
acute or progressive renal disease
severe neurological (especially Guillain-Barré syndrome) or psychiatric disorder
severe asthma
history of any anaphylactic reaction and/or serious allergic reaction to any component of the study vaccine;
a known or suspected (or had a high risk of developing) impairment/alteration of immune function (excluding those normally associated with advanced age) resulting, for example, from:
receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study,
receipt of immunostimulants within the past 6 months,
receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within the past 3 months and for the full length of the study, or
suspected or known human immunodeficiency virus (HIV) infection or HIV-related disease
Had known or suspected drug or alcohol abuse within the past 2 years;
Had bleeding diathesis or conditions associated with prolonged bleeding time that, in the investigator's opinion, would interfere with the safety of the subject;
was not able to comprehend and to follow all required study procedures for the whole period of the study;
Had a history or any illness that, in the opinion of the investigator, would pose additional risk to the subjects because of participation in the study;
Had the following within the past 6 months:
had any laboratory-confirmed seasonal or pandemic influenza disease
received any seasonal or pandemic influenza vaccine
Had received any other vaccine within 4 weeks prior to enrollment in this study or who were planning to receive any vaccine during the study;
Had acute or chronic infections requiring antiviral therapy within the last 7 days;
Had experienced fever (ie, body temperature [preferably oral] ≥38.0°C) within the last 3 days of intended study vaccination;
Had been participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intends to participate in another clinical study at any time during the conduct of this study;
was part of study personnel or has close family members conducting this study;
Had a body mass index (BMI) >35 kg/m2 (BMI is calculated by dividing the subject's weight in kilograms by the subject's height in meters multiplied by the subject's height in meters);
was pregnant (confirmed by positive urine pregnancy test) or nursing (breast feeding) or was a female of childbearing potential who refused to use an acceptable method of birth control for the whole duration of the study.

Trial locations and contacts

1 site in 1 country.

Germany1 site

University Medical Center Hamburg-Eppendorf
Hamburg, 20359

Other trials in Germany

About this study

Official title: A Phase III, Open Label, Single Arm, Multi Center Study to Evaluate Safety and Immunogenicity of a Trivalent, Surface Antigen Inactivated Subunit Influenza Virus (Fluvirin®) in Healthy Adults

The vaccine composition will be based on the World Health Organization (WHO) recommended influenza strains for the 2013/2014 Northern Hemisphere vaccine.

The results of this study are intended to support the use of this vaccine in future influenza seasons if the recommended vaccine composition remains the same, in compliance with the requirements of the current European Union (EU) recommendations for clinical trials related to yearly licensing of influenza vaccines.

Conditions: Human Influenza
Being tested: TIVf
Keywords: Influenza,, Adults,, Elderly,, Immunology,, Safety
Medical subject headings: Influenza, Human

What participants receive

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

TIVfBiological
Trivalent Influenza Virus Vaccine (purified surface antigen, inactivated, egg-derived)

Study groups in NCT01885117
Study group	Role	What they receive
TIVf (18 to ≤ 60 years)	Experimental	Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere Receives: Biological: TIVf
TIVf (≥ 61 years)	Experimental	Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere Receives: Biological: TIVf

What is being measured

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

Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf
Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIVf.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years.
Measured: Day 1 (baseline) and Day 22 (postvaccination)
Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf
Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains ,three weeks after receiving one dose of TIVf.
Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤4mm2 achieving a post vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre vaccination SRH area >4mm2 achieving at least 50% increase in post vaccination SRH area.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years.
Measured: Day 22 (postvaccination) /Day 1 (Baseline)
Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVf
The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIVf.
The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years.
Measured: Day 22 (postvaccination)/ Day 1 (baseline)
Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf
Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIVf.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years.
Measured: Day 1 (baseline) and Day 22 (postvaccination)
Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVf
Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIVf.
Seroconversion is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 to at least a 4-fold increase in post vaccination HI antibody titers.
The related European (CHMP) criterion for the assessment of immunogenicity is met if>40 % for adults aged 18 to ≤60 years and>30% for subjects aged ≥61 years achieve seroconversion or significant increase in post vaccination HI titers.
Measured: Day 22 (postvaccination)/ Day 1 (baseline)
Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf
The antibody responses following one dose of TIVf were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIVf.
The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years.
Measured: Day 22/ Day 1
Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf
The number of adult and elderly subjects reporting solicited local and systemic AEs and other solicited AEs after receiving one dose of TIVf are reported.
Measured: Day 1 through Day 4 postvaccination
Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf
The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period), after receiving one dose of TIVf is reported.
Measured: Day 1(baseline) through Day 22 postvaccination

Timeline

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

Aug 2013Sep 2013

First posted24 Jun 2013 (estimated)
Study startAug 2013
Primary completionSep 2013
Study completionSep 2013

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 Human 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01885117
Sponsor's protocol ID: V78_11S
Other IDs: 2013-000601-23
Status last verified: Feb 2014
First submitted: 19 Jun 2013
Last updated: 12 Mar 2014
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?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Open Label, Single Arm, Multi Center Study to Evaluate Safety and Immunogenicity of a Trivalent, Surface Antigen Inactivated Subunit Influenza Virus (Fluvirin®) in Healthy Adults
ClinicalTrials.gov ID: NCT01885117
Acronym / sponsor ID: V78_11S
Conditions: Human Influenza
Keywords: Influenza,, Adults,, Elderly,, Immunology,, Safety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Aug 2013
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 24 Jun 2013 (estimated)
Results: Posted 12 Mar 2014

Clinical summary

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

The vaccine composition will be based on the World Health Organization (WHO) recommended influenza strains for the 2013/2014 Northern Hemisphere vaccine.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TIVf (18 to ≤ 60 years)	Experimental	Biological: TIVfAdult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
TIVf (≥ 61 years)	Experimental	Biological: TIVfAdult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere

Who may qualify

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

Key inclusion criteria (3 listed)

Male or female volunteer aged 18 years or older, mentally competent, who gave written informed consent prior to study entry;
Able to comply with all the study requirements; and
In good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator

Key exclusion criteria (33 listed)

Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may have interfered with the subject's ability to participate in the study;
any serious chronic or acute disease (in the judgment of the investigator) including, but not limited to
history of any anaphylactic reaction and/or serious allergic reaction to any component of the study vaccine;
a known or suspected (or had a high risk of developing) impairment/alteration of immune function (excluding those normally associated with advanced age) resulting, for example, from:
Had known or suspected drug or alcohol abuse within the past 2 years;

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
TIVfTrivalent Influenza Virus Vaccine (purified surface antigen, inactivated, egg-derived)	Biological	TIVf (18 to ≤ 60 years), TIVf (≥ 61 years)

Primary outcome

Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf
Time frame: Day 1 (baseline) and Day 22 (postvaccination)
Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years.
Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf
Time frame: Day 22 (postvaccination) /Day 1 (Baseline)
Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains ,three weeks after receiving one dose of TIVf. Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤4mm2 achieving a post vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre vaccination SRH area >4mm2 achieving at least 50% increase in post vaccination SRH area. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years.
Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVf
Time frame: Day 22 (postvaccination)/ Day 1 (baseline)
The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years.
Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf
Time frame: Day 1 (baseline) and Day 22 (postvaccination)
Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years.
Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVf
Time frame: Day 22 (postvaccination)/ Day 1 (baseline)
Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIVf. Seroconversion is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 to at least a 4-fold increase in post vaccination HI antibody titers. The related European (CHMP) criterion for the assessment of immunogenicity is met if>40 % for adults aged 18 to ≤60 years and>30% for subjects aged ≥61 years achieve seroconversion or significant increase in post vaccination HI titers.
Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf
Time frame: Day 22/ Day 1
The antibody responses following one dose of TIVf were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years.
Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf
Time frame: Day 1 through Day 4 postvaccination
The number of adult and elderly subjects reporting solicited local and systemic AEs and other solicited AEs after receiving one dose of TIVf are reported.
Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf
Time frame: Day 1(baseline) through Day 22 postvaccination
The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period), after receiving one dose of TIVf is reported.

Results and safety

Results posted to the registry on 12 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TIVf (18 to ≤ 60 Years)	61	61
TIVf (≥ 61 Years)	64	64

Primary outcome: Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf

Time frame: Day 1 (baseline) and Day 22 (postvaccination). Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	TIVf (18 to ≤ 60 Years) n = 60	TIVf (≥ 61 Years) n = 64
Day 1 (H1N1 strain)	17 (8 to 29)	36 (24 to 49)
Day 22 (H1N1 strain)	95 (86 to 99)	80 (68 to 89)
Day 1 (H3N2 strain)	20 (11 to 32)	20 (11 to 32)
Day 22 (H3N2 strain)	82 (70 to 90)	84 (73 to 92)
Day 1 (B strain)	57 (43 to 69)	55 (42 to 67)
Day 22 (B strain)	92 (82 to 97)	92 (83 to 97)

Population analysed: Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) confirmed influenza during the study.

Primary outcome: Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf

Time frame: Day 22 (postvaccination) /Day 1 (Baseline). Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	TIVf (18 to ≤ 60 Years) n = 60	TIVf (≥ 61 Years) n = 64
H1N1 strain	85 (73 to 93)	58 (45 to 70)
H3N2 strain	88 (77 to 95)	73 (61 to 84)
B strain	68 (55 to 80)	67 (54 to 78)

Population analysed: Analysis was done on the per-protocol population

Primary outcome: Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVf

Time frame: Day 22 (postvaccination)/ Day 1 (baseline). Geometric mean (95% Confidence Interval). Unit: Ratio

Measure	TIVf (18 to ≤ 60 Years) n = 60	TIVf (≥ 61 Years) n = 64
H1N1 strain	7.62 (5.83 to 9.95)	3.42 (2.65 to 4.41)
H3N2 strain	3.66 (2.98 to 4.5)	3.05 (2.49 to 3.74)
B strain	2.62 (2.09 to 3.27)	2.33 (1.92 to 2.83)

Population analysed: Analysis was done on the per-protocol population

Primary outcome: Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf

Time frame: Day 1 (baseline) and Day 22 (postvaccination). Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	TIVf (18 to ≤ 60 Years) n = 60	TIVf (≥ 61 Years) n = 64
Day 1 (H1N1 strain)	50 (37 to 63)	56 (43 to 69)
Day 22 (H1N1 strain)	100 (94 to 100)	100 (94 to 100)
Day 1 (H3N2strain)	62 (48 to 74)	73 (61 to 84)
Day 22 (H3N2 strain)	98 (91 to 100)	100 (94 to 100)
Day 1 (B strain)	45 (32 to 58)	45 (33 to 58)
Day 22 (B strain)	93 (84 to 98)	80 (68 to 89)

Population analysed: Analysis was done on the per-protocol population

Adverse events

Time frame: All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day1 to Day 22. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TIVf (18 to ≤ 60 Years)	0 of 61 (0%)	41 of 61 (67.2%)	Not reported
TIVf (≥ 61 Years)	0 of 64 (0%)	24 of 64 (37.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TIVf in people with Human Influenza, run by Novartis Vaccines at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 33 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 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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 12 Mar 2014). 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?

Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf (time frame: Day 1 (baseline) and Day 22 (postvaccination)). The study lists 8 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 NCT01885117.

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 12 Mar 2014.