AsthmaPhase 3ALIZENCT02814643

Study to Evaluate the Potential Effect of Benralizumab on the Humoral Immune Response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients With Severe Asthma

A Phase 3 study testing Benralizumab and Seasonal influenza virus vaccine in people with Asthma, run by AstraZeneca at 24 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

This is a randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of a fixed dose of benralizumab administered subcutaneously (SC) on antibody responses following seasonal influenza virus vaccination Read more about this study

Who is it for?: Ages 12 to 21 years
Conditions the study is for: Asthma
What is being tested?: Benralizumab and Seasonal influenza virus vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 103 participants
Where: 24 sitesUnited States
Study dates: 1 Jul 2016to 24 Jan 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Female and male patients aged 12 to 21 years, inclusive, at the time of Visit 1
Weight of ≥40 kg
Documented history of current treatment with Inhaled corticosteroids (ICS) and long-acting β2 agonists (LABA)
Morning pre-bronchodilator forced expiratory volume in 1 second (FEV1) of >50% predicted at Visit 1 or Visit 2.
Airway reversibility (FEV1 >12% and 200 ml) demonstrated at Visit 1 or Visit 2 using the Maximum Post-bronchodilator Procedure OR
Airway reversibility documented in the previous 12 months prior to Visit 1
An exacerbation, 1 or more, that required oral corticosteroids in the previous year OR
Any condition assessed by patient recall over the previous 2-4 weeks

Who cannot join

Clinically important pulmonary disease other than asthma
Known history of allergy or reaction to the Investigational Product formulation or influenza vaccine
Receipt of an influenza vaccine within 90 days prior to randomization
Poorly controlled asthma during the screening period that requires treatment with oral corticosteroids or a hospitalization/emergency room visit for the treatment of asthma
Acute illness or evidence of significant active infection or known influenza infection during the current flu season

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

Research Site
Arlington, Texas, 76018
Research Site
Aurora, Colorado, 80012-4016
Research Site
Aventura, Florida, 33180
Research Site
Bellevue, Nebraska, 68123
Research Site
Birmingham, Alabama, 35209
Research Site
Clinton, Utah, 84015
Research Site
Colorado Springs, Colorado, 80907
Research Site
Denver, Colorado, 80230
Research Site
Edmond, Oklahoma, 73034
Research Site
El Paso, Texas, 79903
Research Site
Huntington Beach, California, 92647
Research Site
Medford, Oregon, 97504
Research Site
Mesa, Arizona, 85206
Research Site
Miami, Florida, 33135
Research Site
Miami, Florida, 33173
Research Site
Minneapolis, Minnesota, 55402
Research Site
New Braunfels, Texas, 78130
Research Site
Newport Beach, California, 92663
Research Site
North Charleston, South Carolina, 29420
Research Site
Northfield, New Jersey, 08225
Research Site
Oklahoma City, Oklahoma, 73103
Research Site
San Antonio, Texas, 78221
Research Site
San Antonio, Texas, 78251
Research Site
Waco, Texas, 76712

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Potential Effect of Benralizumab on the Humoral Immune Response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients With Severe Asthma.

Read the detailed description

This study is designed to investigate the potential effect of benralizumab on the antibody response to the seasonal influenza virus vaccine in patients 12-21 years of age with asthma. Benralizumab will be given subcutaneously (SC) at Weeks 0, 4, and 8 weeks, at which time benralizumab levels will reach steady state. Patients will then receive 1 dose of intramuscular (IM) seasonal influenza virus vaccine at Week 8 and samples drawn at Week 8 and Week 12 to measure the antibody response to the influenza virus

Conditions: Asthma
Being tested: Benralizumab, Benralizumab Placebo, Seasonal influenza virus vaccine
Keywords: Male and female adolescent patients, severe asthma
Medical subject headings: Asthma

What participants receive

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

BenralizumabDrug
Benralizumab SC administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).
Benralizumab PlaceboDrug
Placebo administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).
Seasonal influenza virus vaccineDrug
Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.

Study groups in NCT02814643
Study group	Role	What they receive
Benralizumab	Experimental	1 mL fill volume administered every 4 weeks for 3 doses (Weeks 0, 4, and 8). Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8. Receives: Drug: Benralizumab; Drug: Seasonal influenza virus vaccine
Placebo	Placebo comparator	1 mL fill volume administered every 4 weeks for 3 doses (Weeks 0, 4, and 8). Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8. Receives: Drug: Benralizumab Placebo; Drug: Seasonal influenza virus vaccine

What is being measured

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

Postdose Strain-specific Hemagglutination-inhibition (HAI) Antibody Geometric Mean Fold Rise From Week 8 to Week 12
To compare the geometric mean fold rises in influenza strain-specific hemagglutination-inhibition responses from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo. Geometric mean fold rise was defined as antilog(z) (mean [log(z) x]), where "x" is the postdose HAI antibody titer fold rise from Week 8 and "z" is the natural logarithm.
Measured: 4 weeks
Postdose Strain-specific Hemagglutination-inhibition Antibody Geometric Mean Titers Obtained at Week 12
To compare the geometric mean titers of hemagglutination-inhibition antibody as a measure of influenza strain-specific response at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
Measured: 12 weeks
Proportion of Patients Who Experienced a Strain-specific Postdose Antibody Response at Week 12 With Antibody Response Defined as a ≥4-fold Rise in Hemagglutination-inhibition Antibody Titer From Week 8 to Week 12
To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥4-fold rises in hemagglutination-inhibition antibody titer from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
Measured: 4 weeks
Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination-inhibition Antibody Titer ≥40 at Week 12
To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥40-fold rises in hemagglutination-inhibition antibody titer at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
Measured: 12 weeks

Secondary outcomes (5)

Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination Inhibition Antibody Titre ≥320 at Week 12
To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥320-fold rises in hemagglutination-inhibition antibody titer at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
Measured: 12 weeks
Postdose Strain-specific Microneutralization Antibody Geometric Mean Fold Rise From Week 8 to Week 12
To compare the geometric mean fold rises in influenza strain-specific microneutralization antibody responses from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo. Geometric mean fold rise was defined as antilog(z) (mean [log(z) x]), where "x" is the postdose microneutralization antibody titer fold rise from Week 8 and "z" is the natural logarithm.
Measured: 4 weeks
Postdose Strain-specific Serum Microneutralization Antibody Geometric Mean Titers Obtained at Week 12
To compare the geometric mean titers of microneutralization antibody as a measure of influenza strain-specific response at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
Measured: 12 weeks
Proportion of Patients Who Experience a Strain-specific Postdose Antibody Response at Week 12 With Antibody Response Defined as a ≥4-fold Rise in Microneutralization Antibody Titer From Week 8 to Week 12
To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥4-fold rises in microneutralization antibody titer from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
Measured: 4 weeks
Change From Baseline in Mean Asthma Control Questionnaire 6 (ACQ-6) Score at Week 12
To compare the change from baseline at Week 12 in mean ACQ-6 score between patients receiving benralizumab 30mg and patients receiving placebo. The ACQ-6 assesses asthma symptoms (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and short-acting β2 agonist use). Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score is the mean of the responses to each question. Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and ≤1.5 indicate partly controlled asthma, and a score >1.5 indicates not well controlled asthma
Measured: 12 weeks

Timeline

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

1 Jul 201624 Jan 2017

First posted28 Jun 2016 (estimated)
Study start1 Jul 2016
Primary completion24 Jan 2017
Study completion24 Jan 2017

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 AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02814643
Sponsor's protocol ID: D3250C00033
Acronym: ALIZE
Status last verified: Oct 2018
First submitted: 15 Jun 2016
Last updated: 24 Oct 2018
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 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Potential Effect of Benralizumab on the Humoral Immune Response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients With Severe Asthma.
ClinicalTrials.gov ID: NCT02814643
Acronym / sponsor ID: ALIZE / D3250C00033
Conditions: Asthma
Keywords: Male and female adolescent patients, severe asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 1 Jul 2016 (actual)
Primary completion: 24 Jan 2017 (actual)
Study completion: 24 Jan 2017 (actual)
First posted: 28 Jun 2016 (estimated)
Results: Posted 1 Mar 2018

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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Benralizumab	Experimental	Drug: Benralizumab, Drug: Seasonal influenza virus vaccine1 mL fill volume administered every 4 weeks for 3 doses (Weeks 0, 4, and 8). Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.
Placebo	Placebo comparator	Drug: Benralizumab Placebo, Drug: Seasonal influenza virus vaccine1 mL fill volume administered every 4 weeks for 3 doses (Weeks 0, 4, and 8). Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.

Who may qualify

Ages: 12 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

Female and male patients aged 12 to 21 years, inclusive, at the time of Visit 1
Weight of ≥40 kg
Documented history of current treatment with Inhaled corticosteroids (ICS) and long-acting β2 agonists (LABA)
Morning pre-bronchodilator forced expiratory volume in 1 second (FEV1) of >50% predicted at Visit 1 or Visit 2.
Airway reversibility (FEV1 >12% and 200 ml) demonstrated at Visit 1 or Visit 2 using the Maximum Post-bronchodilator Procedure OR

Key exclusion criteria (5 listed)

Clinically important pulmonary disease other than asthma
Known history of allergy or reaction to the Investigational Product formulation or influenza vaccine
Receipt of an influenza vaccine within 90 days prior to randomization
Poorly controlled asthma during the screening period that requires treatment with oral corticosteroids or a hospitalization/emergency room visit for the treatment of asthma
Acute illness or evidence of significant active infection or known influenza infection during the current flu season

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
BenralizumabBenralizumab SC administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).	Drug	Benralizumab
Benralizumab PlaceboPlacebo administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).	Drug	Placebo
Seasonal influenza virus vaccinePatients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.	Drug	Benralizumab, Placebo

Primary outcome

Postdose Strain-specific Hemagglutination-inhibition (HAI) Antibody Geometric Mean Fold Rise From Week 8 to Week 12
Time frame: 4 weeks
To compare the geometric mean fold rises in influenza strain-specific hemagglutination-inhibition responses from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo. Geometric mean fold rise was defined as antilog(z) (mean [log(z) x]), where "x" is the postdose HAI antibody titer fold rise from Week 8 and "z" is the natural logarithm.
Postdose Strain-specific Hemagglutination-inhibition Antibody Geometric Mean Titers Obtained at Week 12
Time frame: 12 weeks
To compare the geometric mean titers of hemagglutination-inhibition antibody as a measure of influenza strain-specific response at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
Proportion of Patients Who Experienced a Strain-specific Postdose Antibody Response at Week 12 With Antibody Response Defined as a ≥4-fold Rise in Hemagglutination-inhibition Antibody Titer From Week 8 to Week 12
Time frame: 4 weeks
To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥4-fold rises in hemagglutination-inhibition antibody titer from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination-inhibition Antibody Titer ≥40 at Week 12
Time frame: 12 weeks
To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥40-fold rises in hemagglutination-inhibition antibody titer at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.

5 secondary outcomes

Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination Inhibition Antibody Titre ≥320 at Week 12
Time frame: 12 weeks
Postdose Strain-specific Microneutralization Antibody Geometric Mean Fold Rise From Week 8 to Week 12
Time frame: 4 weeks
Postdose Strain-specific Serum Microneutralization Antibody Geometric Mean Titers Obtained at Week 12
Time frame: 12 weeks
Proportion of Patients Who Experience a Strain-specific Postdose Antibody Response at Week 12 With Antibody Response Defined as a ≥4-fold Rise in Microneutralization Antibody Titer From Week 8 to Week 12
Time frame: 4 weeks
Change From Baseline in Mean Asthma Control Questionnaire 6 (ACQ-6) Score at Week 12
Time frame: 12 weeks

Results and safety

Results posted to the registry on 1 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Benralizumab 30mg	51	50
Placebo	52	49

Primary outcome: Postdose Strain-specific Hemagglutination-inhibition (HAI) Antibody Geometric Mean Fold Rise From Week 8 to Week 12

Time frame: 4 weeks. Geometric least squares mean (Standard Error). Unit: Fold change

Measure	Benralizumab 30mg n = 50	Placebo n = 49
Influenza A H1N1	3.60 (1.22)	3.13 (1.22)
Influenza A H3N2	3.25 (1.18)	3.85 (1.18)
Influenza B Yamagata lineage	3.42 (1.16)	3.17 (1.16)
Influenza B Victoria lineage	4.08 (1.19)	3.27 (1.19)

Benralizumab 30mg vs Placebo: Geometric least-square mean ratio: 0.87 (90% CI 0.56 to 1.35), ANCOVA
Benralizumab 30mg vs Placebo: Geometric least-square mean ratio: 1.19 (90% CI 0.82 to 1.71), ANCOVA
Benralizumab 30mg vs Placebo: Geometric least-square mean ratio: 0.93 (90% CI 0.67 to 1.29), ANCOVA

Population analysed: The vaccine immunogenicity analysis set included all randomized patients who received ≥1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or microneutralization antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.

Primary outcome: Postdose Strain-specific Hemagglutination-inhibition Antibody Geometric Mean Titers Obtained at Week 12

Time frame: 12 weeks. Geometric least squares mean (Standard Error). Unit: Antibody titer

Measure	Benralizumab 30mg n = 50	Placebo n = 49
Influenza A H1N1	521.06 (1.13)	518.60 (1.13)
Influenza A H3N2	170.73 (1.15)	219.35 (1.15)
Influenza B Yamagata lineage	61.47 (1.13)	63.15 (1.13)
Influenza B Victoria lineage	53.10 (1.14)	66.85 (1.14)

Benralizumab 30mg vs Placebo: Geometric least-square mean ratio: 1.00 (90% CI 0.76 to 1.31), ANCOVA
Benralizumab 30mg vs Placebo: Geometric least-square mean ratio: 1.28 (90% CI 0.93 to 1.77), ANCOVA
Benralizumab 30mg vs Placebo: Geometric least-square mean ratio: 1.03 (90% CI 0.79 to 1.34), ANCOVA

Population analysed: The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.

Primary outcome: Proportion of Patients Who Experienced a Strain-specific Postdose Antibody Response at Week 12 With Antibody Response Defined as a ≥4-fold Rise in Hemagglutination-inhibition Antibody Titer From Week 8 to Week 12

Time frame: 4 weeks. Number (90% Confidence Interval). Unit: Proportion of Participants

Measure	Benralizumab 30mg n = 50	Placebo n = 49
Influenza A H1N1	0.440 (0.32 to 0.57)	0.306 (0.20 to 0.43)
Influenza A H3N2	0.500 (0.38 to 0.62)	0.490 (0.37 to 0.62)
Influenza B Yamagata lineage	0.480 (0.36 to 0.60)	0.490 (0.37 to 0.62)
Influenza B Victoria lineage	0.560 (0.43 to 0.68)	0.408 (0.29 to 0.54)

Primary outcome: Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination-inhibition Antibody Titer ≥40 at Week 12

Time frame: 12 weeks. Number (90% Confidence Interval). Unit: Proportion of Participants

Measure	Benralizumab 30mg n = 50	Placebo n = 49
Influenza A H1N1	1.00 (251.9)	1.00 (191.3)
Influenza A H3N2	0.980 (136.2)	0.980 (168.6)
Influenza B Yamagata lineage	0.860 (144.9)	0.796 (115.0)
Influenza B Victoria lineage	0.780 (178.7)	0.878 (162.2)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All AEs, including SAEs, were collected from the time the patient, parent, or legal guardian signed the informed consent/assent throughout the treatment period and including the follow-up period (through Week 20).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Benralizumab 30mg	0 of 51 (0%)	28 of 51 (54.9%)	0 of 51
Placebo	2 of 52 (3.8%)	23 of 52 (44.2%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
CSP redactedLink provided by the sponsor.
Statistical Analysis Plan (SAP)Link provided by the sponsor.
ALIZE\_redacted\_protocol.pdfLink provided by the sponsor.

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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.

Pamela L Zeitlin, M.D. Ph.D. principal investigator

Johns Hopkins University

24 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 Benralizumab and Seasonal influenza virus vaccine in people with Asthma, run by AstraZeneca at 24 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 8 inclusion and 5 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 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 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. Some participants in this study may receive a placebo. 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 1 Mar 2018). 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?

Postdose Strain-specific Hemagglutination-inhibition (HAI) Antibody Geometric Mean Fold Rise From Week 8 to Week 12 (time frame: 4 weeks). The study lists 4 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 NCT02814643.

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 24 Oct 2018.