InfluenzaPhase 3NCT02467842

Immunogenicity and Safety of Quadrivalent Influenza Vaccine (NBP607-QIV) in Adults and Elderly Subjects

A Phase 3 study testing NBP607-QIV, NBP607-Y and NBP607-V in people with Influenza, run by SK Chemicals Co., Ltd..

Completed

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

Trial summary

All participants received a single dose of their assigned vaccine on Day 0. They were followed up for immunogenicity and safety through Day 21 post-vaccination. Serious adverse events were collected for 6 months post-vaccination. Read more about this study

Who is it for?: Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: NBP607-QIV, NBP607-Y and NBP607-V
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,503 participants
Where: No sites listed yet
Study dates: Oct 2014to May 2015
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 19 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adults aged 19 years and older
Those who are able to comply with the requirements for the study
If women, a negative pregnancy test and willingness to use birth control measures for the entire study duration

Who cannot join

Disorders in immune function
Any malignancy or lymphoproliferative disorder
History of Guillain-Barré syndrome
Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
Experience of fever (>38.0 ℃) within 24 hours following vaccination
Body temperature >38.0 ℃ at the vaccination day

Show all 14Show fewer

Concomitant medications/therapy such as immunosuppressants or immune modifying drugs, systemic corticosteroids, immunoglobulins, blood or blood- derived products within 3 months
Influenza vaccination within 6 months
Subjects who have participated in other interventional study within 4 weeks
Any vaccination within 1 month
Those who are planning to receive any vaccine within 1 month from the study vaccine
Individuals with any serious chronic or progressive disease
Pregnant or breast-feeding women
Any other reason that in the opinion of the investigator might interfere with the study

About this study

Official title: A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine in Adults and Elderly Subjects

Read the detailed description

In a randomized controlled phase III trial undertaken in 10 university hospitals of South Korea, adults and elderly subjects were randomly assigned in a 2:1:1 ratio to NBP607-QIV versus cell culture-based trivalent inactivated influenza vaccine (TIV), NBP607-Y and NBP607-V. Immunogenicity was assessed 3 weeks after vaccination by hemagglutination inhibition (HI) assay. Safety was assessed for 6 months post-vaccination: solicited adverse events for 7 days, unsolicited adverse events (AEs) for 21 days and serious adverse events (SAE) for 6 months.

Conditions: Influenza
Being tested: NBP607-QIV, NBP607-Y, NBP607-V
Keywords: Influenza vaccine, Quadrivalent, Inactivated cell culture-derived
Medical subject headings: Influenza, Human

What participants receive

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

NBP607-QIVBiological
Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria
NBP607-YBiological
Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata
NBP607-VBiological
Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria

Study groups in NCT02467842
Study group	Role	What they receive
NBP607-QIV	Experimental	Participants aged 19 years and older received a 0.5mL single intramuscular dose of Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria on Day 0 Receives: Biological: NBP607-QIV
NBP607-Y	Active comparator	Participants aged 19 years and older received a 0.5mL single intramuscular dose of Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata on Day 0 Receives: Biological: NBP607-Y
NBP607-V	Active comparator	Participants aged 19 years and older received a 0.5mL single intramuscular dose of Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria on Day 0 Receives: Biological: NBP607-V

What is being measured

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

Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects
GMTs of anti-influenza antibodies were measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. For each A strain, the titers were made with the pooled TIV group (NBP60-Y and NBP607-V).
For each A strain, the comparion was made with the pooled TIV groups (Y+V/QIV). For each B strain, the comparison was made with the corresponding TIV group(i.e. for B/Yamagata, Geometric Mean Titer Ratio (GMR) is Y/QIV).
Measured: At Day 21 post vaccination.
Seroconversion Rate (SCR) After Vaccination in All Subjects
SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10
For each A strain, the comparion was made with the pooled TIV groups (Y+V minus QIV). For each B strain, the comparison was made with the corresponding TIV group(i.e. for B/Yamagata, Difference of SCR (Diff.SCR) is Y minus QIV).
Measured: At Day 21 post vaccination.
Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
SPR of NBP607-QIV was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroprotection was defined as the proportion of subjects whose post-vaccination HI titer increased to ≥1:40.
Measured: At Day 21 post vaccination.
Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10
Measured: At Day 21 post vaccination.
Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
GMR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMR was defined as the fold-rise of the geometric mean HI titer from pre- to post-vaccination.
Measured: At Day 21 post vaccination.

Secondary outcomes (5)

Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects
GMTs of anti-influenza antibodies were measured for B strains: B/Victoria, and B/Yamagata.
For each B strain, the comparison was made with the TIV group which did not contain the correponding B strain (i.e. for B/Yamagata, Geometric Mean Titer Ratio (GMR) is V/QIV).
Measured: At Day 21 post vaccination.
Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects
SCR was measured for each B strain: B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10
Measured: At Day 21 post vaccination.
Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years
SPR of NBP607-QIV was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroprotection was defined as the proportion of subjects whose post-vaccination HI titer increased to ≥1:40.
Measured: At Day 21 post vaccination.
Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years
SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10
Measured: At Day 21 post vaccination.
Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years
GMR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMR was defined as the fold-rise of the geometric mean HI titer from pre- to post-vaccination
Measured: At Day 21 post vaccination.

Timeline

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

Oct 2014May 2015

First posted10 Jun 2015 (estimated)
Study startOct 2014
Primary completionDec 2014
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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,503 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02467842
Sponsor's protocol ID: NBP607-QIV_FluA_III_2014
Status last verified: Jun 2015
First submitted: 3 Jun 2015
Last updated: 8 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Choi WS, Noh JY, Song JY, Cheong HJ, Wie SH, Lee JS, Lee J, Kim SW, Jeong HW, Jung SI, Kim YS, Woo HJ, Kim KH, Kim H, Kim WJ. Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects. Hum Vaccin Immunother. 2017 Jul 3;13(7):1653-1660. doi: 10.1080/21645515.2017.1297351. Epub 2017 Apr 13.
PubMed 28406746

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine in Adults and Elderly Subjects
ClinicalTrials.gov ID: NCT02467842
Acronym / sponsor ID: NBP607-QIV_FluA_III_2014
Conditions: Influenza
Keywords: Influenza vaccine, Quadrivalent, Inactivated cell culture-derived
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,503 participants (actual)
Lead sponsor: SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Dec 2014 (actual)
Study completion: May 2015 (actual)
First posted: 10 Jun 2015 (estimated)
Results: Posted 8 May 2020

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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
NBP607-QIV	Experimental	Biological: NBP607-QIVParticipants aged 19 years and older received a 0.5mL single intramuscular dose of Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria on Day 0
NBP607-Y	Active comparator	Biological: NBP607-YParticipants aged 19 years and older received a 0.5mL single intramuscular dose of Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata on Day 0
NBP607-V	Active comparator	Biological: NBP607-VParticipants aged 19 years and older received a 0.5mL single intramuscular dose of Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria on Day 0

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adults aged 19 years and older
Those who are able to comply with the requirements for the study
If women, a negative pregnancy test and willingness to use birth control measures for the entire study duration

Key exclusion criteria (14 listed)

Disorders in immune function
Any malignancy or lymphoproliferative disorder
History of Guillain-Barré syndrome
Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
Experience of fever (>38.0 ℃) within 24 hours following vaccination

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
NBP607-QIVQuadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria	Biological	NBP607-QIV
NBP607-YTrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata	Biological	NBP607-Y
NBP607-VTrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria	Biological	NBP607-V

Primary outcome

Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects
Time frame: At Day 21 post vaccination.
GMTs of anti-influenza antibodies were measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. For each A strain, the titers were made with the pooled TIV group (NBP60-Y and NBP607-V). For each A strain, the comparion was made with the pooled TIV groups (Y+V/QIV). For each B strain, the comparison was made with the corresponding TIV group(i.e. for B/Yamagata, Geometric Mean Titer Ratio (GMR) is Y/QIV).
Seroconversion Rate (SCR) After Vaccination in All Subjects
Time frame: At Day 21 post vaccination.
SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10 For each A strain, the comparion was made with the pooled TIV groups (Y+V minus QIV). For each B strain, the comparison was made with the corresponding TIV group(i.e. for B/Yamagata, Difference of SCR (Diff.SCR) is Y minus QIV).
Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
Time frame: At Day 21 post vaccination.
SPR of NBP607-QIV was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroprotection was defined as the proportion of subjects whose post-vaccination HI titer increased to ≥1:40.
Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
Time frame: At Day 21 post vaccination.
SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10
Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
Time frame: At Day 21 post vaccination.
GMR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMR was defined as the fold-rise of the geometric mean HI titer from pre- to post-vaccination.

5 secondary outcomes

Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects
Time frame: At Day 21 post vaccination.
Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects
Time frame: At Day 21 post vaccination.
Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years
Time frame: At Day 21 post vaccination.
Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years
Time frame: At Day 21 post vaccination.
Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years
Time frame: At Day 21 post vaccination.

Results and safety

Results posted to the registry on 8 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NBP607-QIV	752	752
NBP607-Y	373	373
NBP607-V	378	378

Primary outcome: Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects

Time frame: At Day 21 post vaccination.. Geometric mean (95% Confidence Interval). Unit: titers

Measure	NBP607-QIV n = 748	NBP607-Y n = 371	NBP607-V n = 376
A/H1N1	329.76 (309.17 to 351.71)	334.98 (313.91 to 357.47)	334.98 (313.91 to 357.47)
A/H3N2	401.21 (378.87 to 424.87)	377.34 (356.47 to 399.44)	377.34 (356.47 to 399.44)
B/Yamagata	163.74 (156.11 to 171.73)	144.65 (135.54 to 154.37)	123.08 (115.39 to 131.28)
B/Victoria	124.82 (119.16 to 130.75)	93.29 (87.43 to 99.53)	112.20 (105.20 to 119.66)

NBP607-QIV vs NBP607-Y vs NBP607-V: GMR (pooled TIV/QIV): 1.02 (95% CI 0.94 to 1.10)
NBP607-QIV vs NBP607-Y vs NBP607-V: GMR (pooled TIV/QIV): 0.94 (95% CI 0.87 to 1.01)
NBP607-QIV vs NBP607-Y: GMR (TIV/QIV): 0.88 (95% CI 0.82 to 0.95)

Population analysed: Per Protocol Set.

Primary outcome: Seroconversion Rate (SCR) After Vaccination in All Subjects

Time frame: At Day 21 post vaccination.. Number (95% Confidence Interval). Unit: percentage of participants

Measure	NBP607-QIV n = 748	NBP607-Y n = 371	NBP607-V n = 376
A/H1N1	52.41 (48.83 to 55.99)	52.56 (47.48 to 57.64)	50.27 (45.21 to 55.32)
A/H3N2	51.20 (47.62 to 54.79)	46.09 (41.02 to 51.16)	46.28 (41.24 to 51.32)
B/Yamagata	43.72 (40.16 to 47.27)	36.66 (31.75 to 41.56)	24.73 (20.37 to 29.10)
B/Victoria	55.75 (52.19 to 59.31)	43.13 (38.09 to 48.17)	52.66 (47.61 to 57.71)

NBP607-QIV vs NBP607-Y vs NBP607-V: Difference in percentage: -1.00 (95% CI -6.07 to 4.06)
NBP607-QIV vs NBP607-Y vs NBP607-V: Difference in percentage: -5.02 (95% CI -10.08 to 0.04)
NBP607-QIV vs NBP607-Y: Difference in percentage: -7.06 (95% CI -13.12 to -1.00)

Population analysed: Per protocol set

Primary outcome: Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years

Time frame: At Day 21 post vaccination.. Number (95% Confidence Interval). Unit: percentage of participants

Measure	NBP607-QIV n = 152
A/H1N1	92.76 (88.64 to 96.88)
A/H3N2	98.68 (96.87 to 100.00)
B/Yamagata	94.08 (90.33 to 97.83)
B/Victoria	96.05 (92.96 to 99.15)

Population analysed: Per protocol set.

Primary outcome: Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years

Time frame: At Day 21 post vaccination.. Number (95% Confidence Interval). Unit: percentage of participants

Measure	NBP607-QIV n = 152
A/H1N1	52.63 (44.69 to 60.57)
A/H3N2	42.11 (34.26 to 49.95)
B/Yamagata	43.42 (35.54 to 51.30)
B/Victoria	59.87 (52.08 to 67.66)

Population analysed: Per protocol set.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NBP607-QIV	9 of 752 (1.2%)	364 of 752 (48.4%)	0 of 752
NBP607-Y	3 of 373 (0.8%)	154 of 373 (41.3%)	0 of 373
NBP607-V	3 of 378 (0.8%)	151 of 378 (39.9%)	0 of 378

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28406746Choi WS, Noh JY, Song JY, Cheong HJ, Wie SH, Lee JS, Lee J, Kim SW, Jeong HW, Jung SI, Kim YS, Woo HJ, Kim KH, Kim H, Kim WJ. Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects. Hum Vaccin Immunother. 2017 Jul 3;13(7):1653-1660. doi: 10.1080/21645515.2017.1297351. Epub 2017 Apr 13.

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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.

Woo Joo Kim, MD, PhD study chair

Korea University Guro Hospital

Won Suk Choi, MD, PhD principal investigator

Korea University

Seong-Heon Wie, MD, PhD principal investigator

Catholic University St. Vincent's Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NBP607-QIV, NBP607-Y and NBP607-V in people with Influenza, run by SK Chemicals Co., Ltd..

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 14 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 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.

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 8 May 2020). 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 HI Titers (GMTs) After Vaccination in All Subjects (time frame: At Day 21 post vaccination.). The study lists 5 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 NCT02467842, which also lists 1 linked publication.

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 8 May 2020.