H7N9 InfluenzaPhase 1NCT01928472

Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years

A Phase 1 study testing H7N9c low dose with adjuvant, H7N9c medium dose with adjuvant and H7N9c high dose with adjuvant in people with H7N9 Influenza, run by Novartis Vaccines at 6 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 the safety and immunogenicity of four different doses of H7N9 vaccination in adults between the ages of 18 years and 65 years. Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: H7N9 Influenza
What is being tested?: H7N9c low dose with adjuvant, H7N9c medium dose with adjuvant and H7N9c high dose with adjuvant
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 402 participants
Where: 6 sitesUnited States
Study dates: Aug 2013to Sep 2014
Phase: Phase 1
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 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult subject ages 18-64 years.
Individuals willing to provide written informed consent
Individuals in good health.
Individuals who can comply with study procedures and follow-up.

Who cannot join

Individuals with history of cognitive or behavioral impairment or psychiatric disease,
Individuals unable to understand and follow study procedures,
History of significant illness,
History of chronic medical condition or progressive disease,
Allergy to any vaccine component or adverse event related to a vaccine component,
Impairment/alteration of the immune system,

Show all 19Show fewer

Presence of progressive or severe neurological disorder,
Pregnant or breast-feeding,
Female of Child-bearing potential unwilling to use acceptable method of birth control,
Presence of medically significant cancer,
Receipt of investigational product within 30 day prior to entry into the study,
History of previous or suspected illness from avian flu caused by H7N9 virus,
History of H7 vaccination,
Body temperature of greater than or equal to 38.0°C (100.4◦F) and/or acute illness within 3 days of intended study vaccination,
Receipt of any flu vaccination 2 weeks before study entry or 4 weeks after study vaccination,
Receipt of any vaccination 2 weeks before study entry or 4 weeks after study vaccination,
History of drug or alcohol abuse within the past 2 years,
Body Mass Index (BMI) greater than or equal to 35kg/m2,
Individuals conducting the study or their immediate family members.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Site 01: Accelovance
Melbourne, Florida, 32935
Site 02: Accelovance
Peoria, Illinois, 61602
Site 03: Accelovance
Rockville, Maryland, 20850
Site 05: Janet Lewis
Salt Lake City, Utah, 84109
Site 06: Janet Lewis
Salt Lake City, Utah, 84121
Site 04: Accelovance
San Diego, California, 92108

Other trials in United States

About this study

Official title: Phase I Multi-center, Observer-Blind, Randomized Dose-Ranging Study of Adjuvanted and Non-Adjuvanted Cell Culture-Derived, Inactivated A/H7N9 Monovalent Subunit Influenza Virus Vaccine (H7N9c) in Adults 18 to <65 Years

Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults between the ages of 18 years and 65 years.

Conditions: H7N9 Influenza
Being tested: H7N9c low dose with adjuvant, H7N9c medium dose with adjuvant, H7N9c high dose with adjuvant, H7N9c high dose without adjuvant
Keywords: Influenza, H7N9, Vaccine
Medical subject headings: Influenza, Human, Influenza in Birds

What participants receive

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

H7N9c low dose with adjuvantBiological
H7N9c medium dose with adjuvantBiological
H7N9c high dose with adjuvantBiological
H7N9c high dose without adjuvantBiological

Study groups in NCT01928472
Study group	Role	What they receive
Group A	Experimental	H7N9c low dose with adjuvant Receives: Biological: H7N9c low dose with adjuvant
Group B	Experimental	H7N9c medium dose with adjuvant Receives: Biological: H7N9c medium dose with adjuvant
Group C	Experimental	H7N9c high dose with adjuvant Receives: Biological: H7N9c high dose with adjuvant
Group D	Experimental	H7N9c high dose without adjuvant Receives: Biological: H7N9c high dose without adjuvant

What is being measured

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

Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43)
Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination
Measured: Day 1 and 43
Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43)
Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after second (day 43) vaccination.
Measured: Day 43
Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)
Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after second (day 43) vaccination.
Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10.
Measured: Day 43
Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)
Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.
Measured: Day 1 and 43
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Safety was assessed as the number of subjects who reported any AEs, and at least possibly related AEs are collected from day 1 to day 43 following vaccination with adjuvanted and unadjuvanted formulations of H7N9c vaccine.
Measured: Day 1 to Day 43
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
The number of subjects reporting unsolicited adverse events after receiving adjuvanted and unadjuvanted formulations of H7N9c vaccine was reported. Safety was assessed as the number of subjects who reported SAEs, at least possibly related SAEs, new onset of chronic diseases (NOCDs), medically attended AEs, AEs of Special Interest (AESIs), AEs leading to withdrawal from the study were collected from day 1 to day 366 following vaccination with adjuvanted and unadjuvanted formulations of H7N9 vaccine.
Measured: Day 1 to Day 366.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 to day 7 of vaccination of adjuvanted and unadjuvanted formulations of H7N9c vaccine.
Measured: Day 1 through Day 7 after each vaccination.

Secondary outcomes (8)

Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22)
Immunogenicity was measured by HI assay and summarized through the GMTs at baseline (day 1) and three weeks after the first (day 22) vaccination.
Measured: Day 1 and 22
Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22)
GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after first (day 22) vaccination.
Measured: Day 22
Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)
Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after first (day 22) vaccination.
Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10.
Measured: Day 22
Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)
Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after first (Day 22) vaccination.
Measured: Day 1 and 22.
Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)
The immunogenicity was measured as GMTs in subjects as persistence at six months (day 183) and one year (day 366) after the first vaccination as measured by Hemagglutination Inhibition (HI) Assay.
Measured: Day 183 and 366.
Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)
GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs six months (day 183) and one year (day 366) after the first vaccination.
Measured: Day 183 and 366
Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)
Percentage of subjects with HI seroconversion was measured as HI titer persistence at six months (day 183) and one year (day 366) after the first vaccination.
Seroconversion is defined as postvaccination HI titer>40 for subjects with baseline (day 1); HI titer <1:10 or a minimum four-fold increase in titer for subjects with baseline titer>1:10.
Measured: Day 183 and 366
Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)
Percentages of subjects who achieved HI titers≥1:40 was measured at six months (day 183) and one year (day 366) after the first vaccination of a cell-culture derived H7N9 vaccine.
Measured: Day 183 and 366

Timeline

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

Aug 2013Sep 2014

First posted26 Aug 2013 (estimated)
Study startAug 2013
Primary completionSep 2014
Study completionSep 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 H7N9 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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 402 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01928472
Sponsor's protocol ID: V131_01
Status last verified: May 2019
First submitted: 21 Aug 2013
Last updated: 11 Jun 2019
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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All H7N9 Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Multi-center, Observer-Blind, Randomized Dose-Ranging Study of Adjuvanted and Non-Adjuvanted Cell Culture-Derived, Inactivated A/H7N9 Monovalent Subunit Influenza Virus Vaccine (H7N9c) in Adults 18 to <65 Years
ClinicalTrials.gov ID: NCT01928472
Acronym / sponsor ID: V131_01
Conditions: H7N9 Influenza
Keywords: Influenza, H7N9, Vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 402 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Aug 2013
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 26 Aug 2013 (estimated)
Results: Posted 21 May 2015

Clinical summary

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

Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults between the ages of 18 years and 65 years.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Group A	Experimental	Biological: H7N9c low dose with adjuvantH7N9c low dose with adjuvant
Group B	Experimental	Biological: H7N9c medium dose with adjuvantH7N9c medium dose with adjuvant
Group C	Experimental	Biological: H7N9c high dose with adjuvantH7N9c high dose with adjuvant
Group D	Experimental	Biological: H7N9c high dose without adjuvantH7N9c high dose without adjuvant

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy adult subject ages 18-64 years.
Individuals willing to provide written informed consent
Individuals in good health.
Individuals who can comply with study procedures and follow-up.

Key exclusion criteria (19 listed)

Individuals with history of cognitive or behavioral impairment or psychiatric disease,
Individuals unable to understand and follow study procedures,
History of significant illness,
History of chronic medical condition or progressive disease,
Allergy to any vaccine component or adverse event related to a vaccine component,

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
H7N9c low dose with adjuvant	Biological	Group A
H7N9c medium dose with adjuvant	Biological	Group B
H7N9c high dose with adjuvant	Biological	Group C
H7N9c high dose without adjuvant	Biological	Group D

Primary outcome

Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43)
Time frame: Day 1 and 43
Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination
Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43)
Time frame: Day 43
Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after second (day 43) vaccination.
Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)
Time frame: Day 43
Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after second (day 43) vaccination. Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10.
Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)
Time frame: Day 1 and 43
Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Time frame: Day 1 to Day 43
Safety was assessed as the number of subjects who reported any AEs, and at least possibly related AEs are collected from day 1 to day 43 following vaccination with adjuvanted and unadjuvanted formulations of H7N9c vaccine.
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Time frame: Day 1 to Day 366.
The number of subjects reporting unsolicited adverse events after receiving adjuvanted and unadjuvanted formulations of H7N9c vaccine was reported. Safety was assessed as the number of subjects who reported SAEs, at least possibly related SAEs, new onset of chronic diseases (NOCDs), medically attended AEs, AEs of Special Interest (AESIs), AEs leading to withdrawal from the study were collected from day 1 to day 366 following vaccination with adjuvanted and unadjuvanted formulations of H7N9 vaccine.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Time frame: Day 1 through Day 7 after each vaccination.
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 to day 7 of vaccination of adjuvanted and unadjuvanted formulations of H7N9c vaccine.

8 secondary outcomes

Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22)
Time frame: Day 1 and 22
Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22)
Time frame: Day 22
Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)
Time frame: Day 22
Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)
Time frame: Day 1 and 22.
Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)
Time frame: Day 183 and 366.
Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)
Time frame: Day 183 and 366
Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)
Time frame: Day 183 and 366
Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)
Time frame: Day 183 and 366

Results and safety

Results posted to the registry on 21 May 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
Low Dose + Adj	98	90
Medium Dose + Adj	104	96
High Dose + Adj	98	91
High Dose + No Adj	102	100

Primary outcome: Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43)

Time frame: Day 1 and 43. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Low Dose + Adj n = 98	Medium Dose + Adj n = 103	High Dose + Adj n = 98	High Dose + No Adj n = 102
Day 1	5 (4.95 to 5.05)	5 (4.95 to 5.05)	5 (4.95 to 5.05)	5.05 (5 to 5.1)
Day 43	12 (9.75 to 15)	19 (15 to 23)	26 (21 to 32)	5.75 (4.67 to 7.08)

Population analysed: The analysis was done on Full Analysis Set - Subjects who received at least one study vaccination and provided immunogenicity at day 43 (FAS-Day 43).

Primary outcome: Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43)

Time frame: Day 43. Geometric mean (95% Confidence Interval). Unit: Ratio

Measure	Low Dose + Adj n = 94	Medium Dose + Adj n = 103	High Dose + Adj n = 97	High Dose + No Adj n = 102
Value	2.42 (1.95 to 3)	3.7 (3.02 to 4.55)	5.2 (4.21 to 6.43)	1.14 (0.93 to 1.4)

Population analysed: FAS-Day 43

Primary outcome: Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)

Time frame: Day 43. Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	Low Dose + Adj n = 94	Medium Dose + Adj n = 103	High Dose + Adj n = 97	High Dose + No Adj n = 102
Value	26 (17 to 36)	44 (34 to 54)	52 (41 to 62)	3 (1 to 8)

Population analysed: FAS-Day 43

Primary outcome: Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)

Time frame: Day 1 and 43. Number (95% Confidence Interval). Unit: Percentages of subejcts

Measure	Low Dose + Adj n = 98	Medium Dose + Adj n = 103	High Dose + Adj n = 98	High Dose + No Adj n = 102
Day 1	0 (0 to 4)	0 (0 to 4)	0 (0 to 4)	0 (0 to 4)
Day 43	26 (17 to 36)	44 (34 to 54)	52 (41 to 62)	3 (1 to 8)

Population analysed: FAS-Day 43.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dose + Adj	2 of 98 (2%)	71 of 98 (72.4%)	Not reported
Medium Dose + Adj	2 of 103 (1.9%)	87 of 103 (84.5%)	Not reported
High Dose + Adj	3 of 98 (3.1%)	79 of 98 (80.6%)	Not reported
High Dose + No Adj	1 of 102 (1%)	62 of 102 (60.8%)	Not reported
TOTAL	8 of 401 (2%)	299 of 401 (74.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
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 and Diagnostics study chair

Novartis Vaccines

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

Questions about this trial

What is this clinical trial studying?

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 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 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 21 May 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?

Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43) (time frame: Day 1 and 43). The study lists 7 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 NCT01928472.

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 11 Jun 2019.