InfluenzaPhase 4NCT03308825

Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines

A Phase 4 study testing Fluzone Quadrivalent vaccine and Fluzone High-Dose vaccine in people with Influenza and Flu, run by Sanofi Pasteur, a Sanofi Company at 3 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

The aim of the study was to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone Quadrivalent vaccine in children 6 months to < 9 years of age, and in adults 18 to < 65 years of age, and to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone High-Dose vaccine in… Read more about this study

Who is it for?: Ages 6 months and olderHealthy volunteers can take part
Conditions the study is for: Influenza, Flu
What is being tested?: Fluzone Quadrivalent vaccine and Fluzone High-Dose vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 3 sitesUnited States
Study dates: 11 Sep 2017to 22 Nov 2017
Phase: Phase 4
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 months and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Aged 6 months to < 9 years or ≥ 18 years on the day of first study vaccination (study product administration).
For participants 6 to < 12 months of age, born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg (5.5 lbs).
Informed consent form has been signed and dated by participants ≥ 18 years of age.
Assent form was signed and dated by participants 7 to < 9 years of age, and informed consent form has been signed and dated by parent(s) or guardian(s) for participants 6 months to < 9 years of age.
Participant and parent/guardian (of participants 6 months to < 9 years of age) were able to attend all scheduled visits and to comply with all study procedures.

Who cannot join

Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post- menopausal for at least 1 year, or surgically sterile.
Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Note: Participants may be considered eligible for enrollment if no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the participant would complete safety surveillance for the present study.
Receipt of any vaccine in the 30 days preceding the first study vaccination, or planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine.
Previous vaccination against influenza (in the 2017-2018 influenza season) with either study vaccine or another vaccine.
Receipt of immune globulins, blood, or blood-derived products in the 3 months preceding planned inclusion.
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the 6 months preceding planned inclusion; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the 3 months preceding planned inclusion).

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Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to study vaccine or to a vaccine containing any of the same substances. Note: The list of vaccine components is included in the Prescribing Information for each study vaccine.
Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
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, was at a stage where it might interfere with study conduct or completion.
Moderate or severe acute illness/infection (according to Investigator judgment) on the day of planned vaccination or febrile illness (temperature ≥ 100.4 degree Fahrenheit [°F] [38.0 degrees Celsius {°C}]). A prospective participant 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 (participants ≥ 18 years of age) 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 (all participants).
History of serious adverse reaction to any influenza vaccine.
Personal history of Guillain-Barré syndrome.
Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine.
Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder.
Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Sanofi Pasteur Investigational Site 002
Bardstown, Kentucky, 40004
Sanofi Pasteur Investigational Site 003
Council Bluffs, Iowa, 51503
Sanofi Pasteur Investigational Site 001
Metairie, Louisiana, 70006

Other trials in United States

About this study

Official title: Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2017-2018 Formulations

Read the detailed description

All participants received 1 intramuscular dose of their assigned vaccine during Visit 1. For participants, for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of the same volume as the first dose was administered during Visit 2 (28 days after Visit 1). Solicited adverse reaction (AR) information was collected for 7 days following each vaccination. Unsolicited non-serious adverse event (AE) and serious adverse event (SAE) information was collected from Visit 1 to Visit 2 or from Visit 1 to Visit 3 for those participants receiving 2 doses of study vaccine.

Immunogenicity was evaluated in all participants prior to vaccination on Day 0 (Visit 1) and after the final vaccination (Day 28 post-final vaccination for participants 6 months to < 9 years of age and Day 21 post-vaccination for participants ≥ 18 years of age).

Conditions: Influenza, Flu
Being tested: Fluzone Quadrivalent vaccine, Fluzone High-Dose vaccine
Keywords: Influenza, Flu
Medical subject headings: Influenza, Human

What participants receive

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

Fluzone Quadrivalent vaccineBiological
0.25 mL, Intramuscular
Fluzone Quadrivalent vaccineBiological
0.5 mL, Intramuscular
Fluzone High-Dose vaccineBiological
0.5 mL, Intramuscular

Study groups in NCT03308825
Study group	Role	What they receive
Group 1: 6 to < 36 Months	Experimental	Children aged 6 to < 36 months received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28. Receives: Biological: Fluzone Quadrivalent vaccine
Group 2: 3 to < 9 Years	Experimental	Children aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28. Receives: Biological: Fluzone Quadrivalent vaccine
Group 3: 18 to < 65 Years	Experimental	Adults aged 18 to < 65 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Receives: Biological: Fluzone Quadrivalent vaccine
Group 4: >= 65 Years	Experimental	Adults aged >= 65 years received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. Receives: Biological: Fluzone High-Dose vaccine

What is being measured

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

Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months)
Solicited injection site reactions: Pain, Erythema and Swelling (Grade 3: Pain: cries when injected limb moved/ limb movement reduced, erythema and swelling >= 50 mm). Solicited systemic reactions: Fever, vomiting, abnormal crying, drowsiness, appetite lost, Irritability (Grade 3: Fever: >= 39.5 degrees Celsius [103.1 degree Fahrenheit {°F}], vomiting >= six episodes per 24 hours, abnormal crying : > 3 hours, drowsiness: sleeping most of the time or difficult to wake up, appetite lost: refuses >= 3 feeds/meals or refuses most feeds/meals, Irritability: Inconsolable).
Measured: Within 7 days after any vaccination
Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years)
Solicited injection site reactions: Pain (Group 2: Grade 3: Incapacitating; Group 3 and 4: Grade 3: significant; prevents daily activity), erythema \& swelling (Group 2: Grade 3: >= 50 mm, Group 3 and 4: Grade 3: > 100 mm). Solicited systemic reactions: Fever (Grade 3: >= 39.0 degrees Celsius [102.2°F]), headache, malaise \& myalgia (Grade 3: significant interference with daily activities).
Measured: Within 7 days after any vaccination
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
Anti-influenza antibodies were measured using the hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage.
Measured: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4).
Measured: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
GMT Ratios (GMTRs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
GMTRs are the geometric means of the individual post-final vaccination/pre-vaccination titer ratios for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage, measured using the HAI assay.
Measured: Day 0 (pre-vaccination) and Day 28 (post-final vaccination)
GMTRs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
GMTRs are the geometric means of the individual post-final vaccination/pre-vaccination titer ratios for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4), measured using the HAI assay.
Measured: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
Anti-influenza antibodies were measured using the HAI assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. Seroprotection was defined as antibody titer >=40 (1/ dilution) at pre-vaccination or at post-final vaccination.
Measured: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). Seroprotection was defined as antibody titer >= 40 (1/ dilution) at pre-vaccination or at post-final vaccination.
Measured: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
Anti-influenza antibodies were measured using the HAI assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-final vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-final vaccination titer.
Measured: Day 0 (pre-vaccination) and Day 28 (post-final vaccination)
Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-final vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-final vaccination titer.
Measured: Day 0 (pre-vaccination) and 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.

11 Sep 201722 Nov 2017

First posted13 Oct 2017
Study start11 Sep 2017
Primary completion22 Nov 2017
Study completion22 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for 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 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Multicenter, Open-label, Phase IV Study
Masking: None (open label)
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03308825
Sponsor's protocol ID: GRC73
Other IDs: U1111-1183-5816
Status last verified: Mar 2022
First submitted: 28 Sep 2017
Last updated: 29 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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

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 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2017-2018 Formulations
ClinicalTrials.gov ID: NCT03308825
Acronym / sponsor ID: GRC73
Conditions: Influenza, Flu
Keywords: Influenza, Flu
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 11 Sep 2017 (actual)
Primary completion: 22 Nov 2017 (actual)
Study completion: 22 Nov 2017 (actual)
First posted: 13 Oct 2017 (actual)
Results: Posted 17 Dec 2018

Clinical summary

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: Multicenter, Open-label, Phase IV Study

Arm	Type	Receives
Group 1: 6 to < 36 Months	Experimental	Biological: Fluzone Quadrivalent vaccineChildren aged 6 to < 36 months received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
Group 2: 3 to < 9 Years	Experimental	Biological: Fluzone Quadrivalent vaccineChildren aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
Group 3: 18 to < 65 Years	Experimental	Biological: Fluzone Quadrivalent vaccineAdults aged 18 to < 65 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
Group 4: >= 65 Years	Experimental	Biological: Fluzone High-Dose vaccineAdults aged >= 65 years received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.

Who may qualify

Ages: 6 months and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Aged 6 months to < 9 years or ≥ 18 years on the day of first study vaccination (study product administration).
For participants 6 to < 12 months of age, born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg (5.5 lbs).
Informed consent form has been signed and dated by participants ≥ 18 years of age.
Assent form was signed and dated by participants 7 to < 9 years of age, and informed consent form has been signed and dated by parent(s) or guardian(s) for participants 6 months to < 9 years of age.
Participant and parent/guardian (of participants 6 months to < 9 years of age) were able to attend all scheduled visits and to comply with all study procedures.

Key exclusion criteria (19 listed)

Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post- menopausal for at least 1 year, or surgically sterile.
Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Note: Participants may be considered eligible for enrollment if no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the participant would complete safety surveillance for the present study.
Receipt of any vaccine in the 30 days preceding the first study vaccination, or planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine.
Previous vaccination against influenza (in the 2017-2018 influenza season) with either study vaccine or another vaccine.
Receipt of immune globulins, blood, or blood-derived products in the 3 months preceding planned inclusion.

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
Fluzone Quadrivalent vaccine0.25 mL, Intramuscular	Biological	Group 1: 6 to < 36 Months
Fluzone Quadrivalent vaccine0.5 mL, Intramuscular	Biological	Group 2: 3 to < 9 Years, Group 3: 18 to < 65 Years
Fluzone High-Dose vaccine0.5 mL, Intramuscular	Biological	Group 4: >= 65 Years

Primary outcome

Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months)
Time frame: Within 7 days after any vaccination
Solicited injection site reactions: Pain, Erythema and Swelling (Grade 3: Pain: cries when injected limb moved/ limb movement reduced, erythema and swelling >= 50 mm). Solicited systemic reactions: Fever, vomiting, abnormal crying, drowsiness, appetite lost, Irritability (Grade 3: Fever: >= 39.5 degrees Celsius [103.1 degree Fahrenheit {°F}], vomiting >= six episodes per 24 hours, abnormal crying : > 3 hours, drowsiness: sleeping most of the time or difficult to wake up, appetite lost: refuses >= 3 feeds/meals or refuses most feeds/meals, Irritability: Inconsolable).
Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years)
Time frame: Within 7 days after any vaccination
Solicited injection site reactions: Pain (Group 2: Grade 3: Incapacitating; Group 3 and 4: Grade 3: significant; prevents daily activity), erythema \& swelling (Group 2: Grade 3: >= 50 mm, Group 3 and 4: Grade 3: > 100 mm). Solicited systemic reactions: Fever (Grade 3: >= 39.0 degrees Celsius [102.2°F]), headache, malaise \& myalgia (Grade 3: significant interference with daily activities).
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
Time frame: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Anti-influenza antibodies were measured using the hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage.
GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
Time frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4).
GMT Ratios (GMTRs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
Time frame: Day 0 (pre-vaccination) and Day 28 (post-final vaccination)
GMTRs are the geometric means of the individual post-final vaccination/pre-vaccination titer ratios for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage, measured using the HAI assay.
GMTRs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
Time frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
GMTRs are the geometric means of the individual post-final vaccination/pre-vaccination titer ratios for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4), measured using the HAI assay.
Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
Time frame: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Anti-influenza antibodies were measured using the HAI assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. Seroprotection was defined as antibody titer >=40 (1/ dilution) at pre-vaccination or at post-final vaccination.
Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
Time frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). Seroprotection was defined as antibody titer >= 40 (1/ dilution) at pre-vaccination or at post-final vaccination.
Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
Time frame: Day 0 (pre-vaccination) and Day 28 (post-final vaccination)
Anti-influenza antibodies were measured using the HAI assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-final vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-final vaccination titer.
Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
Time frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-final vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-final vaccination titer.

Results and safety

Results posted to the registry on 17 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: 6 to < 36 Months	59	57
Group 2: 3 to < 9 Years	61	57
Group 3: 18 to < 65 Years	60	59
Group 4: >= 65 Years	60	60

Primary outcome: Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months)

Time frame: Within 7 days after any vaccination. Count of participants. Unit: Participants

Measure	Group 1: 6 to < 36 Months n = 59
Tenderness	16
Tenderness : Grade 3	1
Erythema	4
Erythema : Grade 3	0
Swelling	2
Swelling : Grade 3	0
Fever	6
Fever : Grade 3	0

Population analysed: Analysis was performed using the Safety Analysis Set. Here, "Number analyzed" corresponds to participants with available data for each listed solicited reaction.

Primary outcome: Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years)

Time frame: Within 7 days after any vaccination. Count of participants. Unit: Participants

Measure	Group 2: 3 to < 9 Years n = 61	Group 3: 18 to < 65 Years n = 60	Group 4: >= 65 Years n = 60
Pain	25	27	20
Pain: Grade 3	1	1	0
Erythema	9	0	3
Erythema : Grade 3	3	0	0
Swelling	11	1	2
Swelling : Grade 3	2	0	0
Fever	1	0	1
Fever : Grade 3	1	0	1

Population analysed: Analysis was performed using Safety Analysis Set. Here, "Number analyzed" corresponds to participants with available data for each listed solicited reaction.

Primary outcome: Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)

Time frame: Day 0 (pre-vaccination) and Day 28 (post-vaccination). Geometric mean (95% Confidence Interval). Unit: Titers (1/dilutions)

Measure	Group 1: 6 to < 36 Months n = 52	Group 2: 3 to < 9 Years n = 55
Pre-Vaccination: A/H1N1	19.9 (11.9 to 33.1)	306 (198 to 473)
Pre-Vaccination: A/H3N2	49.7 (27.7 to 89.2)	415 (253 to 681)
Pre-Vaccination: B Victoria	32.0 (19.7 to 52.0)	180 (112 to 290)
Pre-Vaccination: B Yamagata	43.5 (27.6 to 68.5)	334 (219 to 510)
Post-Final Vaccination: A/H1N1	450 (301 to 671)	1606 (1198 to 2153)
Post-Final Vaccination: A/H3N2	568 (336 to 958)	2370 (1712 to 3282)
Post-Final Vaccination: B Victoria	481 (313 to 738)	1668 (1142 to 2436)
Post-Final Vaccination: B Yamagata	698 (465 to 1047)	2187 (1610 to 2971)

Population analysed: Per-Protocol Analysis Set (PPAS) included all participants who received at least 1dose of study vaccine, had a valid post-final vaccination serology result for at least 1 strain and did not have any major protocol deviations. Here, "Number analyzed" corresponds to participants with available data for each listed strain.

Primary outcome: GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)

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

Measure	Group 3: 18 to < 65 Years n = 56	Group 4: >= 65 Years n = 59
Pre-Vaccination: A/H1N1	165 (110 to 248)	74.6 (52.3 to 106)
Pre-Vaccination: A/H3N2	231 (150 to 356)	194 (130 to 291)
Pre-Vaccination: B Victoria	276 (185 to 412)	215 (151 to 305)
Pre-Vaccination: B Yamagata	425 (308 to 587)	–
Post-Final Vaccination: A/H1N1	756 (539 to 1062)	393 (275 to 561)
Post-Final Vaccination: A/H3N2	1128 (791 to 1610)	864 (612 to 1218)
Post-Final Vaccination: B Victoria	1117 (853 to 1463)	644 (465 to 892)
Post-Final Vaccination: B Yamagata	1312 (1010 to 1704)	–

Population analysed: Analysis was performed on PPAS. Here, "Number analyzed" corresponds to participants with available data for each listed strain and "0" in the number analyzed field signifies that none of the participants were analyzed, since the 2017-2018 formulation of Fluzone High-Dose vaccine did not contain the B Yagamata lineage strain.

Adverse events

Time frame: Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Groups 1 and 2; up to Day 21 for Groups 3 and 4.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: 6 to < 36 Months	0 of 59 (0%)	30 of 59 (50.8%)	0 of 59
Group 2: 3 to < 9 Years	0 of 61 (0%)	30 of 61 (49.2%)	0 of 61
Group 3: 18 to < 65 Years	2 of 60 (3.3%)	29 of 60 (48.3%)	0 of 60
Group 4: >= 65 Years	0 of 60 (0%)	30 of 60 (50%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

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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.

Medical Director study director

Sanofi Pasteur, a Sanofi Company

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluzone Quadrivalent vaccine and Fluzone High-Dose vaccine in people with Influenza and Flu, run by Sanofi Pasteur, a Sanofi Company at 3 sites in United States.

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

Who may be eligible to take part?

The sponsor lists 5 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 29 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 3 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 17 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months) (time frame: Within 7 days after any vaccination). The study lists 10 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 NCT03308825.

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 29 Mar 2022.