InfluenzaPhase 3NCT02550197

Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Given by Intramuscular Route in Subjects Aged 18 to 60 Years

A Phase 3 study testing Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 and Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 5 sites in South Korea.

Completed

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

Official record

Search all trials

Trial summary

The aim of the trial is to evaluate immunogenicity and safety of the quadrivalent influenza vaccine (QIV) and the trivalent influenza vaccine (TIV) (split-virion inactivated) Northern Hemisphere (NH) 2015 2016 seasonal formulations, in subjects aged 18 to 60 years in the Republic of Korea for the registration of the… Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 and Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 5 sitesSouth Korea
Study dates: Sep 2015to Jul 2016
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 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Aged 18 to 60 years on the day of inclusion
Subjects aged 18 years: Assent form has been signed and dated by the subject or by an independent witness, and informed consent form has been signed and dated by at least one parent or another legally acceptable representative or by an independent witness Subjects aged 19 to 60 years: Informed consent form has been signed and dated by the subject or by an independent witness
Subject and parent/legally acceptable representative (if applicable) are able to attend all scheduled visits and to comply with all trial procedures

Who cannot join

Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 3 weeks after vaccination)
Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine until the second visit, 3 weeks following the trial vaccination
Vaccination against influenza if administered in the context of a clinical trial or a flu vaccination campaign or self-reported history of influenza infection (influenza-like illness) in the previous 6 months
Receipt of immune globulins, blood or blood-derived products in the past 3 months
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

Show all 15Show fewer

Known history of seropositivity for Human Immunodeficiency Virus (HIV) or Hepatitis C
Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and octoxynol-9, or to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances
Known or suspected thrombocytopenia, contraindicating intramuscular vaccination, based on Investigator's judgment
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination, based on Investigator's judgment
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Current alcohol abuse or drug addiction
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

South Korea5 sites

Study site
Ansan-si, 425-707
Study site
Incheon, 400-712
Study site
Seoul, 120-752
Study site
Seoul, 150-950
Study site
Seoul, 152-840

Other trials in South Korea

About this study

Official title: Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Subjects Aged 18 to 60 Years in the Republic of Korea

Objectives:

To evaluate the immunogenicity of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations. The compliance, in terms of immunogenicity, of the QIV NH 2015-2016 formulation, with the requirements of the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 will be assessed.
To evaluate the safety profile of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations

Read the detailed description

All subjects will receive one dose of either QIV or TIV on Day 0. They will be monitored for safety and immunogenicity for up to Day 21 post-vaccination.

Conditions: Influenza
Being tested: Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016, Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation
Keywords: Influenza, Quadrivalent influenza vaccine, Trivalent 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.

Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016Biological
0.5 mL, Intramuscular
Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulationBiological
0.5 mL, Intramuscular

Study groups in NCT02550197
Study group	Role	What they receive
QIV Group	Experimental	Subjects will receive one dose of the Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation Receives: Biological: Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016
TIV Group	Active comparator	Subjects will receive one dose of the Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation Receives: Biological: Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation

What is being measured

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

Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
Measured: Day 0 (pre-vaccination) and Day 21 post-vaccination
Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 21.
Measured: Day 0 (pre-vaccination) and Day 21 post-vaccination
Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
Measured: Day 0 (pre-vaccination) and Day 21 post-vaccination
Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as titers < 10 (1/dil) on Day 0 and post-injection titer ≥ 40 (1/dil) on Day 21, and Significant increase was defined as titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-injection titer on Day 21.
Measured: Day 21 post-vaccination
Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
Measured: Day 0 (pre-vaccination) and Day 21 post-vaccination
Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
The solicited reactions evaluated were Injection-site Induration (≥50 mm for at least 4 consecutive days), Injection-site Ecchymosis (injection site bruising), Pyrexia (recorded temperature >38.0˚C for at least 1 day), Malaise, and Shivering (rigors).
Measured: Day 0 up Day 3 post-vaccination
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Solicited Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Solicited Systemic reactions: Fever, ≥ 39.0˚C; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity.
Measured: Day 0 up Day 7 post-vaccination

Timeline

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

Sep 2015Jul 2016

First posted15 Sep 2015 (estimated)
Study startSep 2015
Primary completionApr 2016
Study completionJul 2016

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.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02550197
Sponsor's protocol ID: GQM07
Other IDs: U1111-1143-9015
Status last verified: Mar 2022
First submitted: 11 Sep 2015
Last updated: 28 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

Choi WS, Noh JY, Lee J, Choi JY, Lee JS, Kim MS, Kim HS, Bang J, Lavis N, Kim WJ. Immunogenicity and safety of a split-virion quadrivalent influenza vaccine in adults 18-60 years of age in the Republic of Korea. Hum Vaccin Immunother. 2018 Mar 4;14(3):587-592. doi: 10.1080/21645515.2017.1381808. Epub 2017 Nov 17.
PubMed 28933625

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

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Subjects Aged 18 to 60 Years in the Republic of Korea
ClinicalTrials.gov ID: NCT02550197
Acronym / sponsor ID: GQM07
Conditions: Influenza
Keywords: Influenza, Quadrivalent influenza vaccine, Trivalent influenza vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: Apr 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 15 Sep 2015 (estimated)
Results: Posted 4 Nov 2016

Clinical summary

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

Objectives:

To evaluate the immunogenicity of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations. The compliance, in terms of immunogenicity, of the QIV NH 2015-2016 formulation, with the requirements of the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 will be assessed.
To evaluate the safety profile of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations

Detailed description

All subjects will receive one dose of either QIV or TIV on Day 0. They will be monitored for safety and immunogenicity for up to Day 21 post-vaccination.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
QIV Group	Experimental	Biological: Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016Subjects will receive one dose of the Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation
TIV Group	Active comparator	Biological: Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulationSubjects will receive one dose of the Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Aged 18 to 60 years on the day of inclusion
Subjects aged 18 years: Assent form has been signed and dated by the subject or by an independent witness, and informed consent form has been signed and dated by at least one parent or another legally acceptable representative or by an independent witness Subjects aged 19 to 60 years: Informed consent form has been signed and dated by the subject or by an independent witness
Subject and parent/legally acceptable representative (if applicable) are able to attend all scheduled visits and to comply with all trial procedures

Key exclusion criteria (15 listed)

Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 3 weeks after vaccination)
Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine until the second visit, 3 weeks following the trial vaccination
Vaccination against influenza if administered in the context of a clinical trial or a flu vaccination campaign or self-reported history of influenza infection (influenza-like illness) in the previous 6 months
Receipt of immune globulins, blood or blood-derived products in the past 3 months

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
Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-20160.5 mL, Intramuscular	Biological	QIV Group
Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation0.5 mL, Intramuscular	Biological	TIV Group

Primary outcome

Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 21.
Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Time frame: Day 21 post-vaccination
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as titers < 10 (1/dil) on Day 0 and post-injection titer ≥ 40 (1/dil) on Day 21, and Significant increase was defined as titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-injection titer on Day 21.
Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Time frame: Day 0 up Day 3 post-vaccination
The solicited reactions evaluated were Injection-site Induration (≥50 mm for at least 4 consecutive days), Injection-site Ecchymosis (injection site bruising), Pyrexia (recorded temperature >38.0˚C for at least 1 day), Malaise, and Shivering (rigors).
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Time frame: Day 0 up Day 7 post-vaccination
Solicited Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Solicited Systemic reactions: Fever, ≥ 39.0˚C; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity.

Results and safety

Results posted to the registry on 4 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Quadrivalent Influenza Vaccine Group	200	200
Trivalent Influenza Vaccine Group	100	100

Primary outcome: Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route

Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titers (1/dilution)

Measure	Quadrivalent Influenza Vaccine Group n = 199	Trivalent Influenza Vaccine Group n = 100
A/H1N1; Day 0 (N=199, 99)	142 (116 to 174)	116 (86.1 to 155)
A/H1N1; Day 21 (N=199, 99)	583 (516 to 658)	651 (550 to 771)
A/H3N2; Day 0 (N=199, 99)	41.6 (34.1 to 50.9)	35.8 (27.2 to 47.0)
A/H3N2; Day 21 (N=199, 99)	483 (406 to 574)	691 (543 to 881)
B/Phuket; Day 0 (N=199, 99)	256 (212 to 309)	219 (166 to 290)
B/Phuket; Day 21 (N=199, 99)	1068 (950 to 1200)	1105 (933 to 1308)
B/Bris; Day 0 (N=199, 100)	186 (156 to 220)	139 (107 to 180)
B/Bris; Day 21 (N=199, 100)	737 (651 to 835)	290 (231 to 364)

Population analysed: Geometric mean titers of influenza antibodies were assessed in the Immunogenicity Analysis Set.

Primary outcome: Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route

Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination. Number. Unit: Percentage of Participants

Measure	Quadrivalent Influenza Vaccine Group n = 199	Trivalent Influenza Vaccine Group n = 100
A/H1N1; Day 0 (N=199, 99)	83.4	78.8
A/H1N1; Day 21 (N=199, 99)	99.5	100.0
A/H3N2; Day 0 (N=199, 99)	56.3	55.6
A/H3N2; Day 21 (N=199, 99)	98.0	99.0
B/Phuket; Day 0 (N=199, 99)	91.5	87.9
B/Phuket; Day 21 (N=199, 99)	100.0	100.0
B/Bris; Day 0 (N=199, 100)	89.4	85.0
B/Bris; Day 21 (N=199, 100)	100.0	97.0

Population analysed: Seroprotection was assessed in the Immunogenicity Analysis Set.

Primary outcome: Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route

Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination. Number. Unit: Percentage of Participants

Measure	Quadrivalent Influenza Vaccine Group n = 199	Trivalent Influenza Vaccine Group n = 100
A/H1N1; Day 0 (N=199, 99)	5.5	6.1
A/H1N1; Day 21 (N=199, 99)	0.0	0.0
A/H3N2; Day 0 (N=199, 99)	17.1	20.2
A/H3N2; Day 21 (N=199, 99)	0.0	0.0
B/Phuket; Day 0 (N=199, 99)	1.5	1.0
B/Phuket; Day 21 (N=199, 99)	0.0	0.0
B/Bris; Day 0 (N=199, 100)	0.5	2.0
B/Bris; Day 21 (N=199, 100)	0.0	0.0

Population analysed: Immunogenicity was assessed in the Immunogenicity Analysis Set.

Primary outcome: Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route

Time frame: Day 21 post-vaccination. Number. Unit: Percentage of Participants

Measure	Quadrivalent Influenza Vaccine Group n = 199	Trivalent Influenza Vaccine Group n = 100
A/H1N1 (N=199, 99)	39.7	46.5
A/H3N2 (N=199, 99)	72.4	84.8
B/Phuket (N=199, 99)	48.7	53.5
B/Bris (N=199, 100)	46.2	23.0

Population analysed: Immunogenicity was assessed in the Immunogenicity Analysis Set.

Adverse events

Time frame: Adverse event data were collected from Day 0 up to Day 21 post-vaccination.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Quadrivalent Influenza Vaccine Group	0 of 200 (0%)	141 of 200 (70.5%)	Not reported
Trivalent Influenza Vaccine Group	0 of 100 (0%)	64 of 100 (64%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28933625Choi WS, Noh JY, Lee J, Choi JY, Lee JS, Kim MS, Kim HS, Bang J, Lavis N, Kim WJ. Immunogenicity and safety of a split-virion quadrivalent influenza vaccine in adults 18-60 years of age in the Republic of Korea. Hum Vaccin Immunother. 2018 Mar 4;14(3):587-592. doi: 10.1080/21645515.2017.1381808. Epub 2017 Nov 17.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Related trials for Influenza

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

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.

Medical Director study director

Sanofi Pasteur SA

5 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 15 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 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Korea. 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 4 Nov 2016). 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 Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route (time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination). 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 NCT02550197, 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 28 Mar 2022.