Influenza, HumanPhase 3NCT02914275

A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.

A Phase 3 study testing Seqirus Quadrivalent Inactivated Influenza Vaccine and Comparator Quadrivalent Inactivated Influenza Vaccine in people with Influenza, Human, run by Seqirus at 39 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 study to assess the immune (antibody) response and safety of a Seqirus split virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US licensed 2016/2017 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 6 months through 59 months of age. Read more about this study

Who is it for?: Ages 6 to 59 monthsHealthy volunteers can take part
Conditions the study is for: Influenza, Human
What is being tested?: Seqirus Quadrivalent Inactivated Influenza Vaccine and Comparator Quadrivalent Inactivated Influenza Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,250 participants
Where: 39 sitesUnited States
Study dates: 27 Sep 2016to 11 Aug 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 6 to 59 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Male or female subject 6 months through to 59 months of age at the time of first vaccination and born between 36 and 42 weeks of gestation;
Parent or legally acceptable representative able to provide written informed consent and be willing and able to adhere to all protocol requirements including blood draws.
Subject is in generally good health as per the Investigator's medical judgment

Who cannot join

History of allergic reactions to egg proteins or any components of the Study Vaccines;
History of serious adverse reactions to any influenza vaccines;
History of Guillain-Barré syndrome or other demyelinating disease such as encephalomyelitis and transverse myelitis;
History of licensed or investigational influenza vaccination in the last 6 months;
Clinical signs of active infection and/or an axillary temperature of ≥ 99.5°F / (≥ 37.5 °C) on the day of vaccination or within 48 hours preceding vaccination.
Current or recent, acute or chronic medical conditions that in the opinion of the Investigator are clinically significant and/or unstable

Show all 16Show fewer

History of any seizures, with the exception of a single febrile seizure;
Self-reported or known seropositivity suggestive of acute or chronic viral infection for human immunodeficiency virus, hepatitis B or hepatitis C;
Known or suspected congenital or acquired immunosuppressive conditions;
Current or recent immunosuppressive or immunomodulatory therapy
Current or medical history of malignant neoplasms;
Administration of immunoglobulin and/or any blood products within the previous 90 days preceding the administration of the Study Vaccine or planned administration during the study;
Participation in a clinical trial or use of an investigational compound within 28 days prior to or 28 days after receiving the Study Vaccine, or plans to enter a study during this period;
Vaccination with a licensed vaccine 21 days (for live or inactivated vaccines) prior to receiving the Study Vaccine, or plans to receive any licensed vaccine prior to the Study Exit Visit.
Medical conditions or treatment contraindicating intramuscular vaccination due to increased risk of bleeding.
Family members of the employees of the Investigator or study center with direct involvement in the study, or with other clinical studies under the direction of that Investigator or study center.

Trial locations and contacts

39 sites in 1 country.

City, postcode or hospital

39 sites in 1 country

United States39 sites

Site 430
Anaheim, California, 92804
Site 437
Anaheim, California, 92804
Site 429
Asheboro, North Carolina, 27203
Site 390
Augusta, Kansas, 67010
Site 283
Austin, Texas, 78705
Site 285
Binghamton, New York, 13901
Site 434
Birmingham, Alabama, 35205
Site 308
Bristol, Tennessee, 37620
Site 419
Charleston, South Carolina, 29407
Site 438
Charlottesville, Virginia, 22902
Site 446
Cincinnati, Ohio, 45229
Site 427
Dayton, Ohio, 45419
Site 423
Downey, California, 90241
Site 282
Fort Worth, Texas, 76135
Site 444
Kingsport, Tennessee, 37660
Site 395
Layton, Utah, 84041
Site 443
Louisville, Kentucky, 40202
Site 420
Louisville, Kentucky, 40291
Site 441
Louisville, Kentucky, 40291
Site 289
Meridian, Idaho, 83642
Site 393
Metairie, Louisiana, 70002
Site 436
Metairie, Louisiana, 70006
Site 418
Miami, Florida, 33175
Site 426
Miami, Florida, 33176
Site 442
Mobile, Alabama, 36608
Site 421
Newton, Kansas, 67114
Site 397
Ontario, California, 91762
Site 445
Paramount, California, 90723
Site 402
Sacramento, California, 95822
Site 431
Salt Lake City, Utah, 84109
Site 424
Salt Lake City, Utah, 84121
Site 428
Salt Lake City, Utah, 84124
Site 288
San Angelo, Texas, 76904
Site 425
San Diego, California, 92103
Site 439
Spartanburg, South Carolina, 29303
Site 440
West Jordan, Utah, 84084
Site 433
West Jordan, Utah, 84088
Site 435
West Jordan, Utah, 84088
Site 422
Wichita, Kansas, 67205

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Multicenter, Observer-blinded, Noninferiority Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Inactivated Influenza Virus Vaccine (Seqirus QIV) With a US-licensed Quadrivalent Inactivated Comparator Influenza Virus Vaccine (Comparator QIV) in a Pediatric Population 6 Months Through 59 Months of Age

Conditions: Influenza, Human
Being tested: Seqirus Quadrivalent Inactivated Influenza Vaccine, Comparator Quadrivalent Inactivated Influenza Vaccine
Medical subject headings: Influenza, Human

What participants receive

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

Seqirus Quadrivalent Inactivated Influenza VaccineBiological
Also called Seqirus QIV
The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season). Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle of the arm if muscle mass is adequate) in children 12 months through 35 months of age.
Comparator Quadrivalent Inactivated Influenza VaccineBiological
Also called Comparator QIV
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season. Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection of the non-dominant arm in children 36 months through 59 months of age.

Study groups in NCT02914275
Study group	Role	What they receive
Seqirus QIV Cohort A	Experimental	Seqirus Quadrivalent Inactivated Influenza Vaccine - Subjects 6 months through 35 months of age Receives: Biological: Seqirus Quadrivalent Inactivated Influenza Vaccine
Seqirus QIV Cohort B	Experimental	Seqirus Quadrivalent Inactivated Influenza Vaccine - Subjects 36 months through 59 months of age Receives: Biological: Seqirus Quadrivalent Inactivated Influenza Vaccine
Comparator QIV Cohort A	Active comparator	Comparator Quadrivalent Inactivated Influenza Vaccine - Subjects 6 months through 35 months of age Receives: Biological: Comparator Quadrivalent Inactivated Influenza Vaccine
Comparator QIV Cohort B	Active comparator	Comparator Quadrivalent Inactivated Influenza Vaccine - Subjects 36 months through 59 months of age Receives: Biological: Comparator Quadrivalent Inactivated Influenza Vaccine

What is being measured

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

The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.
Noninferiority of Seqirus QIV compared to comparator QIV was assessed by hemagglutination inhibition (HI) antibody geometric mean titer (GMT) for each viral strain included in the vaccines. The GMT ratio is defined as the geometric mean of the postvaccination HI titer for the US-licensed comparator QIV over the geometric mean of the postvaccination HI titer for Seqirus QIV.
B/VIC = B/Victoria B/YAM = B/Yamagata
Measured: Postvaccination (28 days after last vaccination)
The Difference in Seroconversion Rate (SCR) for Each Virus Strain.
Noninferiority of Seqirus QIV compared to comparator QIV will be assessed by seroconversion rate (SCR) for each viral strain. SCR is defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI titer. For the SCR comparison, the difference between the SCR for each vaccine (for each strain) will be determined.
Measured: Postvaccination (28 days after last vaccination)

Secondary outcomes (8)

Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE)
Frequency and severity of solicited local adverse reactions and systemic AEs for 7 days after each vaccination dose
Measured: Postvaccination (up to 7 days after vaccination)
Number of Participants With Cellulitis-like Reactions
Frequency of cellulitis-like reactions for at least 28 days after each vaccination dose
Measured: Postvaccination (up to 28 days after each vaccination)
Number of Participants With Unsolicited AEs
Frequency and severity of unsolicited AEs for at least 28 days after each vaccination dose
Measured: Postvaccination (up to 28 days after vaccination)
Number of Participants With Serious Adverse Events (SAE)
Frequency of SAEs for 180 days after the last vaccination dose. SAE = serious adverse events, AESI = adverse event of special interest
Measured: 180 days after the last vaccination dose.
Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain
The humoral immune response will be assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate geometric mean of HI titers prevaccination \& postvaccination.
Measured: 28 days after last vaccination.
Seroconversion Rates (SCRs) of Each Virus Strain
The humoral immune response will be assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate SCRs defined as the % of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination titer.
Measured: 28 days after last vaccination
Seroprotection Rates of Each Virus Strain
The humoral immune response will be assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate the percentage of subjects with a titer ≥40 (seroprotection rates) at Day 1 and at Study Exit Visit.
Measured: 28 days after last vaccination.
Geometric Mean Fold Increase (GMFI) of Each Virus Strain
The humoral immune response will be assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate GMFIs, defined as the geometric mean fold titer change (rise) from Day 1 to Study Exit Visit.
Measured: Prevaccination (Day 1) and Postvaccination (28 days after last vaccination)

Timeline

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

27 Sep 201611 Aug 2017

First posted26 Sep 2016 (estimated)
Study start27 Sep 2016
Primary completion9 Mar 2017
Study completion11 Aug 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Influenza, HumanStudies 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: 2,250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02914275
Sponsor's protocol ID: CSLCT-QIV-15-03
Status last verified: Nov 2018
First submitted: 22 Sep 2016
Last updated: 23 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Statler VA, Albano FR, Airey J, Sawlwin DC, Graves Jones A, Matassa V, Heijnen E, Edelman J, Marshall GS. Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in children 6-59 months of age: A phase 3, randomized, noninferiority study. Vaccine. 2019 Jan 7;37(2):343-351. doi: 10.1016/j.vaccine.2018.07.036. Epub 2018 Jul 26.
PubMed 30057283

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Multicenter, Observer-blinded, Noninferiority Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Inactivated Influenza Virus Vaccine (Seqirus QIV) With a US-licensed Quadrivalent Inactivated Comparator Influenza Virus Vaccine (Comparator QIV) in a Pediatric Population 6 Months Through 59 Months of Age
ClinicalTrials.gov ID: NCT02914275
Acronym / sponsor ID: CSLCT-QIV-15-03
Conditions: Influenza, Human
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,250 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Study start: 27 Sep 2016 (actual)
Primary completion: 9 Mar 2017 (actual)
Study completion: 11 Aug 2017 (actual)
First posted: 26 Sep 2016 (estimated)
Results: Posted 23 Jan 2019

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Seqirus QIV Cohort A	Experimental	Biological: Seqirus Quadrivalent Inactivated Influenza VaccineSeqirus Quadrivalent Inactivated Influenza Vaccine - Subjects 6 months through 35 months of age
Seqirus QIV Cohort B	Experimental	Biological: Seqirus Quadrivalent Inactivated Influenza VaccineSeqirus Quadrivalent Inactivated Influenza Vaccine - Subjects 36 months through 59 months of age
Comparator QIV Cohort A	Active comparator	Biological: Comparator Quadrivalent Inactivated Influenza VaccineComparator Quadrivalent Inactivated Influenza Vaccine - Subjects 6 months through 35 months of age
Comparator QIV Cohort B	Active comparator	Biological: Comparator Quadrivalent Inactivated Influenza VaccineComparator Quadrivalent Inactivated Influenza Vaccine - Subjects 36 months through 59 months of age

Who may qualify

Ages: 6 to 59 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Male or female subject 6 months through to 59 months of age at the time of first vaccination and born between 36 and 42 weeks of gestation;
Parent or legally acceptable representative able to provide written informed consent and be willing and able to adhere to all protocol requirements including blood draws.
Subject is in generally good health as per the Investigator's medical judgment

Key exclusion criteria (16 listed)

History of allergic reactions to egg proteins or any components of the Study Vaccines;
History of serious adverse reactions to any influenza vaccines;
History of Guillain-Barré syndrome or other demyelinating disease such as encephalomyelitis and transverse myelitis;
History of licensed or investigational influenza vaccination in the last 6 months;
Clinical signs of active infection and/or an axillary temperature of ≥ 99.5°F / (≥ 37.5 °C) on the day of vaccination or within 48 hours preceding 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
Seqirus Quadrivalent Inactivated Influenza VaccineAlso: Seqirus QIVThe Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season). Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle of the arm if muscle mass is adequate) in children 12 months through 35 months of age.	Biological	Seqirus QIV Cohort A, Seqirus QIV Cohort B
Comparator Quadrivalent Inactivated Influenza VaccineAlso: Comparator QIVThe comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season. Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection of the non-dominant arm in children 36 months through 59 months of age.	Biological	Comparator QIV Cohort A, Comparator QIV Cohort B

Primary outcome

The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.
Time frame: Postvaccination (28 days after last vaccination)
Noninferiority of Seqirus QIV compared to comparator QIV was assessed by hemagglutination inhibition (HI) antibody geometric mean titer (GMT) for each viral strain included in the vaccines. The GMT ratio is defined as the geometric mean of the postvaccination HI titer for the US-licensed comparator QIV over the geometric mean of the postvaccination HI titer for Seqirus QIV. B/VIC = B/Victoria B/YAM = B/Yamagata
The Difference in Seroconversion Rate (SCR) for Each Virus Strain.
Time frame: Postvaccination (28 days after last vaccination)
Noninferiority of Seqirus QIV compared to comparator QIV will be assessed by seroconversion rate (SCR) for each viral strain. SCR is defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI titer. For the SCR comparison, the difference between the SCR for each vaccine (for each strain) will be determined.

8 secondary outcomes

Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE)
Time frame: Postvaccination (up to 7 days after vaccination)
Number of Participants With Cellulitis-like Reactions
Time frame: Postvaccination (up to 28 days after each vaccination)
Number of Participants With Unsolicited AEs
Time frame: Postvaccination (up to 28 days after vaccination)
Number of Participants With Serious Adverse Events (SAE)
Time frame: 180 days after the last vaccination dose.
Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain
Time frame: 28 days after last vaccination.
Seroconversion Rates (SCRs) of Each Virus Strain
Time frame: 28 days after last vaccination
Seroprotection Rates of Each Virus Strain
Time frame: 28 days after last vaccination.
Geometric Mean Fold Increase (GMFI) of Each Virus Strain
Time frame: Prevaccination (Day 1) and Postvaccination (28 days after last vaccination)

Results and safety

Results posted to the registry on 23 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Seqirus QIV	1,687	1,566
Comparator QIV	563	521

Primary outcome: The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.

Time frame: Postvaccination (28 days after last vaccination). Geometric mean (95% Confidence Interval). Unit: Geometric Mean Titer

Measure	Seqirus QIV n = 1456	Comparator QIV n = 484
A/H1N1	370.0 (345.13 to 396.55)	311.7 (276.88 to 350.90)
A/H3N2	436.8 (403.04 to 473.28)	589.1 (516.42 to 671.91)
B/YAM	25.5 (23.93 to 27.06)	29.7 (26.51 to 33.21)
B/VIC	56.8 (52.90 to 60.96)	57.9 (51.04 to 65.62)

Seqirus QIV vs Comparator QIV: Geometric Mean Titer Ratio: 0.79 (95% CI 0.72 to 0.88)
Seqirus QIV vs Comparator QIV: Geometric Mean Titer Ratio: 1.27 (95% CI 1.15 to 1.42)
Seqirus QIV vs Comparator QIV: Geometric Mean Titer Ratio: 1.12 (95% CI 1.01 to 1.24)

Population analysed: The Per-Protocol Population (PPS) comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.

Primary outcome: The Difference in Seroconversion Rate (SCR) for Each Virus Strain.

Time frame: Postvaccination (28 days after last vaccination). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Seqirus QIV n = 1456	Comparator QIV n = 484
A/H1N1	79.1 (76.9 to 81.1)	68.8 (64.5 to 72.9)
A/H3N2	82.3 (80.2 to 84.2)	84.9 (81.4 to 88.0)
B/YAM	38.9 (36.4 to 41.4)	41.9 (37.5 to 46.5)
B/VIC	60.2 (57.6 to 62.7)	61.1 (56.6 to 65.4)

Seqirus QIV vs Comparator QIV: Seroconversion Rate Difference: -10.3 (95% CI -15.4 to -5.1)
Seqirus QIV vs Comparator QIV: Seroconversion Rate Difference: 2.6 (95% CI -2.54 to 7.8)
Seqirus QIV vs Comparator QIV: Seroconversion Rate Difference: 3.1 (95% CI -2.1 to 8.2)

Population analysed: The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Seqirus QIV	11 of 1,673 (0.7%)	320 of 1,673 (19.1%)	0 of 1,673
Comparator QIV	3 of 559 (0.5%)	80 of 559 (14.3%)	0 of 559

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30057283Statler VA, Albano FR, Airey J, Sawlwin DC, Graves Jones A, Matassa V, Heijnen E, Edelman J, Marshall GS. Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in children 6-59 months of age: A phase 3, randomized, noninferiority study. Vaccine. 2019 Jan 7;37(2):343-351. doi: 10.1016/j.vaccine.2018.07.036. Epub 2018 Jul 26.
Individual participant dataSharing planned: Undecided

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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.

39 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 3 inclusion and 16 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 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 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 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 23 Jan 2019). 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?

The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. (time frame: Postvaccination (28 days after last vaccination)). The study lists 2 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 NCT02914275, 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 23 Jan 2019.