Human InfluenzaPhase 2NCT02427750

A Study to Evaluate Safety and Immunogenicity of Trivalent Influenza Vaccine, Formulation 2015 Southern Hemisphere, When Administered to Healthy Adult Subjects.

A Phase 2 study testing Aggripal® in people with Human Influenza, run by Novartis at 1 site in Brazil.

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 evaluate the safety and immunogenicity of trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years. 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?: Aggripal®
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 1 siteBrazil
Study dates: Apr 2015to May 2015
Phase: Phase 2
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

Individuals of 18 years of age and above on the day of informed consent.
Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
Individuals who can comply with study procedures including follow-up.
Males or females of non-child bearing potential or females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the last study vaccination.

Who cannot join

Progressive, unstable or uncontrolled clinical conditions.
Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
Clinical conditions representing a contraindication to intramuscular vaccination and blood drawn.
Abnormal function of the immune system resulting from:
Clinical conditions,
Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent,

Show all 31Show fewer

Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent,
Received immunoglobulins or any blood products within 180 days prior to enrollment.
Received an investigational or non-registered medicinal product within 30 days prior to enrollment.
Study personnel as an immediate family or household member.
Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
Has behavioral or cognitive impairment, psychiatric disease, severe neurological (especially Guillain-Barré syndrome) that, in the opinion of the investigator may interfere with the subject's ability to participate in the study.
Has a serious chronic or acute disease (in the judgment of the investigator may interfere with the result of the study or pose additional risk to the subject) 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 (i.e., New York Heart Association [NYHA] class III and IV),
chronic obstructive pulmonary disease (ie, Global initiative for chronic Obstructive Lung Disease stage III and IV),
autoimmune disease (including rheumatoid arthritis and excepting Hashimoto's thyroiditis that has been clinically stable for ≥5 years),
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 (e.g., Down's syndrome),
acute or progressive hepatic disease,
acute or progressive renal disease,
severe asthma.
Has known or suspected drug or alcohol abuse within the past 2 years;
Has the following within the past 6 months:
had any laboratory-confirmed seasonal or pandemic influenza disease,
received any seasonal or pandemic influenza vaccine,
Has acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days;
Has experienced fever (i.e., body temperature [preferably axillary] ≥38.0°C) within the last 3 days of intended study vaccination;
Has 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

100
Salvador, Estado de Bahia, 40420000

Other trials in Brazil

About this study

Official title: A Phase II, Open-Label, Single-Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of a Surface Antigen, Inactivated, Egg-Derived, Trivalent Influenza (Agrippal®) Virus Vaccine, Southern Hemisphere Formulation 2015, in Healthy Adults.

The present study is designed to evaluate the safety and immunogenicity of trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years.

For the immunogenicity endpoint the antibody response to each influenza vaccine antigen will be evaluated by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post vaccination.

The vaccine composition will be based on the WHO recommended influenza strains for the 2015 Southern Hemisphere vaccine, and the data from this study are intended to support the use of this vaccine in future influenza seasons if the recommended vaccine composition remains the same.

Conditions: Human Influenza
Being tested: Aggripal®
Medical subject headings: Influenza, Human

What participants receive

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

Aggripal®Biological
TIV

Study groups in NCT02427750
Study group	Role	What they receive
Trivalent Influenza Vaccine	Experimental	One injection of Agrippal® Receives: Biological: Aggripal®

What is being measured

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

Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm^2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm^2 against each of the three vaccine strains, three weeks after receiving one dose of TIV.
The related European Committee for Medicinal Products for Human Use (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm^2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years.
Measured: Day 1 and Day 22 post vaccination
Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
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 TIV.
Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤ 4mm^2 achieving a post vaccination SRH area ≥ 25mm^2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area > 4mm^2 achieving at least 50% increase in post vaccination SRH area.
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 SRH areas.
Measured: Day 22 post vaccination
Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Area (GMAs), After One Dose of TIV.
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 TIV.
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 in for subjects aged ≥61 years.
Measured: Day 22/ Day1 post vaccination
Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
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 TIV.
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 and Day 22 post vaccination
Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV.
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 TIV.
Seroconversion is defined as percentage of subjects with a pre vaccination HI titer <10 and a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 and 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 post vaccination
GMR of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV.
The antibody responses following one vaccination of TIV 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 TIV.
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 post vaccination
Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.
The number of adult and elderly subjects reporting solicited local and systemic AEs and other solicited AEs after receiving one dose of TIV are reported.
Measured: Day 1 to Day 4 post vaccination (including 30 mins)
Number of Subjects Reporting Unsolicited AEs After Receiving One Dose of TIV.
The number of subjects in both age groups reporting any unsolicited AEs between Day 1 to Day 4 after receiving one dose of TIV.
Measured: Day 1 to Day 4 post vaccination
Number of Subjects Reporting Unsolicited AEs After Receiving One Vaccination of TIV.
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 (Day 1 to Day 22), after receiving one vaccination of TIV is reported.
Measured: Day 1 to Day 22 post vaccination

Timeline

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

Apr 2015May 2015

First posted28 Apr 2015 (estimated)
Study startApr 2015
Primary completionMay 2015
Study completionMay 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.
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 2
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02427750
Sponsor's protocol ID: V71_40S
Status last verified: Sep 2015
First submitted: 13 Apr 2015
Last updated: 19 Oct 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 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Open-Label, Single-Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of a Surface Antigen, Inactivated, Egg-Derived, Trivalent Influenza (Agrippal®) Virus Vaccine, Southern Hemisphere Formulation 2015, in Healthy Adults.
ClinicalTrials.gov ID: NCT02427750
Acronym / sponsor ID: V71_40S
Conditions: Human Influenza
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Collaborators: Novartis Vaccines
Study start: Apr 2015
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 28 Apr 2015 (estimated)
Results: Posted 19 Oct 2015

Clinical summary

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

The present study is designed to evaluate the safety and immunogenicity of trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Trivalent Influenza Vaccine	Experimental	Biological: Aggripal®One injection of Agrippal®

Who may qualify

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

Key inclusion criteria (4 listed)

Individuals of 18 years of age and above on the day of informed consent.
Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
Individuals who can comply with study procedures including follow-up.
Males or females of non-child bearing potential or females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the last study vaccination.

Key exclusion criteria (31 listed)

Progressive, unstable or uncontrolled clinical conditions.
Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
Clinical conditions representing a contraindication to intramuscular vaccination and blood drawn.
Abnormal function of the immune system resulting from:
Received immunoglobulins or any blood products within 180 days prior to enrollment.

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
Aggripal®TIV	Biological	Trivalent Influenza Vaccine

Primary outcome

Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm^2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
Time frame: Day 1 and Day 22 post vaccination
Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm^2 against each of the three vaccine strains, three weeks after receiving one dose of TIV. The related European Committee for Medicinal Products for Human Use (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm^2 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 TIV.
Time frame: Day 22 post vaccination
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 TIV. Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤ 4mm^2 achieving a post vaccination SRH area ≥ 25mm^2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area > 4mm^2 achieving at least 50% increase in post vaccination SRH area. 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 SRH areas.
Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Area (GMAs), After One Dose of TIV.
Time frame: Day 22/ Day1 post vaccination
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 TIV. 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 in 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 TIV.
Time frame: Day 1 and Day 22 post vaccination
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 TIV. 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 TIV.
Time frame: Day 22 post vaccination
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 TIV. Seroconversion is defined as percentage of subjects with a pre vaccination HI titer <10 and a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 and 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.
GMR of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV.
Time frame: Day 22/Day 1 post vaccination
The antibody responses following one vaccination of TIV 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 TIV. 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 Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.
Time frame: Day 1 to Day 4 post vaccination (including 30 mins)
The number of adult and elderly subjects reporting solicited local and systemic AEs and other solicited AEs after receiving one dose of TIV are reported.
Number of Subjects Reporting Unsolicited AEs After Receiving One Dose of TIV.
Time frame: Day 1 to Day 4 post vaccination
The number of subjects in both age groups reporting any unsolicited AEs between Day 1 to Day 4 after receiving one dose of TIV.
Number of Subjects Reporting Unsolicited AEs After Receiving One Vaccination of TIV.
Time frame: Day 1 to Day 22 post vaccination
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 (Day 1 to Day 22), after receiving one vaccination of TIV is reported.

Results and safety

Results posted to the registry on 19 Oct 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
TIV (18 to ≤ 60 Years)	63	63
TIV (≥ 61 Years)	63	63

Primary outcome: Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm^2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.

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

Measure	TIV (18 to ≤ 60 Years) n = 63	TIV (≥ 61 Years) n = 62
A/H1N1 (Day 1)	62 (49 to 74)	52 (39 to 65)
A/H3N2 (Day 1)	51 (38 to 64)	40 (28 to 54)
B strains (Day 1)	71 (59 to 82)	61 (48 to 73)
A/H1N1 (Day 22)	98 (91 to 100)	63 (50 to 75)
A/H3N2 (Day 22)	84 (73 to 92)	73 (60 to 83)
B strains (Day 22)	94 (85 to 98)	84 (72 to 92)

Population analysed: The analysis was performed on the per-protocol population (PP).

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

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

Measure	TIV (18 to ≤ 60 Years) n = 63	TIV (≥ 61 Years) n = 62
A/H1N1	46 (33 to 59)	39 (27 to 52)
A/H3N2	49 (36 to 62)	47 (34 to 60)
B strains	48 (35 to 61)	32 (21 to 45)

Population analysed: The analysis was performed on the PP dataset

Primary outcome: Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Area (GMAs), After One Dose of TIV.

Time frame: Day 22/ Day1 post vaccination. Geometric mean (95% Confidence Interval). Unit: Ratio

Measure	TIV (18 to ≤ 60 Years) n = 63	TIV (≥ 61 Years) n = 62
A/H1N1	2.3 (1.79 to 2.95)	1.58 (1.39 to 1.81)
A/H3N2	2.48 (1.8 to 3.42)	2.18 (1.59 to 2.99)
B strains	2.28 (1.75 to 2.98)	1.72 (1.35 to 2.17)

Population analysed: The analysis was performed on the PP dataset.

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

Time frame: Day 1 and Day 22 post vaccination. Number (95% Confidence Interval). Unit: Percentages of Subjects

Measure	TIV (18 to ≤ 60 Years) n = 63	TIV (≥ 61 Years) n = 62
A/H1N1 (Day 1)	89 (78 to 95)	90 (80 to 96)
A/H3N2 (Day 1)	79 (67 to 89)	87 (76 to 94)
B strains (Day 1)	46 (33 to 59)	40 (28 to 54)
A/H1N1 (Day 22)	100 (94 to 100)	98 (91 to 100)
A/H3N2 (Day 22)	100 (94 to 100)	100 (94 to 100)
B strains (Day 22)	92 (82 to 97)	60 (46 to 72)

Population analysed: The analysis was performed on the PP dataset.

Adverse events

Time frame: Throughout the study, up to 22 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TIV (18 to ≤ 60 Years)	0 of 63 (0%)	27 of 63 (42.9%)	Not reported
TIV (≥ 61 Years)	0 of 63 (0%)	33 of 63 (52.4%)	Not reported
Total	0 of 126 (0%)	60 of 126 (47.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 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.

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 2 study testing Aggripal® in people with Human Influenza, run by Novartis at 1 site in Brazil.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 31 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 19 Oct 2015. 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 Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 19 Oct 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?

Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm^2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV. (time frame: Day 1 and Day 22 post vaccination). The study lists 9 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 NCT02427750.

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 19 Oct 2015.