InfluenzaPhase 4GRC90NCT03617523

Safety and Immunogenicity of Fluzone® Quadrivalent, Flublok® Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2018-2019 Formulations

A Phase 4 study testing Fluzone Quadrivalent vaccine, 2018-2019 formulation, Flublok Quadrivalent vaccine, 2018-2019 formulation and Fluzone High-Dose vaccine, 2018-2019 formulation in people with Influenza, 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 primary objectives of this study were: To describe the immunogenicity of the 2018-2019 formulation of Fluzone® Quadrivalent vaccine in children 6 to less than (<) 36 months of age and 3 to <9 years of age, and in adults 18 to <65 years of age; the immunogenicity of the 2018-2019 formulation of Flublok®… Read more about this study

Who is it for?: Ages 6 months and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Fluzone Quadrivalent vaccine, 2018-2019 formulation, Flublok Quadrivalent vaccine, 2018-2019 formulation and Fluzone High-Dose vaccine, 2018-2019 formulation
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: 10 Sep 2018to 12 Nov 2018
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 kilograms (kg) (5.5 pounds [lbs.]).
Informed consent form (ICF) had been signed and dated by participants >=18 years of age.
Assent form had been signed and dated by participants 7 to <9 years of age, and ICF had been signed and dated by parent(s) or guardian(s) for participants 6 months to <9 years of age.
Participants 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.
Receipt of any vaccine in the 30 days preceding the first study vaccination, or planned receipt of any vaccine before Visit 2 for participants who received 1 dose of influenza vaccine or Visit 3 for participants who received 2 doses of influenza vaccine.
Previous vaccination against influenza (in the 2018-2019 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.
Thrombocytopenia, which might 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 [38.0 degree Celsius]). A prospective participant was not included in the study until the condition had resolved or the febrile event had 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.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Investigational Site Number 8400003
Bardstown, Kentucky, 40004
Investigational Site Number 8400001
Metairie, Louisiana, 70006
Investigational Site Number 8400002
Salt Lake City, Utah, 84121

Other trials in United States

About this study

The primary objectives of this study were:

To describe the immunogenicity of the 2018-2019 formulation of Fluzone® Quadrivalent vaccine in children 6 to less than (<) 36 months of age and 3 to <9 years of age, and in adults 18 to <65 years of age; the immunogenicity of the 2018-2019 formulation of Flublok® Quadrivalent vaccine in adults 18 to <65 years of age; and the immunogenicity of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults greater than or equal to (>=) 65 years of age.
To describe the safety of the 2018-2019 formulation of Fluzone Quadrivalent vaccine in children 6 to <36 months of age and 3 to <9 years of age, and in adults 18 to <65 years of age; the safety of the 2018-2019 formulation of Flublok Quadrivalent vaccine in adults 18 to <65 years of age; and the safety of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults >=65 years of age.

Read the detailed description

Study duration per participant was approximately 21 days for adult participants or 28 days for child participants who received one dose of vaccine, and 56 days for participants who received two doses of vaccine.

Conditions: Influenza
Being tested: Fluzone Quadrivalent vaccine, 2018-2019 formulation, Flublok Quadrivalent vaccine, 2018-2019 formulation, Fluzone High-Dose vaccine, 2018-2019 formulation
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 vaccine, 2018-2019 formulationBiological
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Flublok Quadrivalent vaccine, 2018-2019 formulationBiological
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Fluzone High-Dose vaccine, 2018-2019 formulationBiological
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Study groups in NCT03617523
Study group	Role	What they receive
Fluzone Quadrivalent vaccine Group 1: 6 to <36 months	Experimental	Participants (aged 6 to <36 months) received a 0.25-milliliter (mL) dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. Receives: Biological: Fluzone Quadrivalent vaccine, 2018-2019 formulation
Fluzone Quadrivalent vaccine Group 2: 3 to <9 years	Experimental	Participants (aged 3 to <9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. Receives: Biological: Fluzone Quadrivalent vaccine, 2018-2019 formulation
Fluzone Quadrivalent vaccine Group 3: 18 to <65 years	Experimental	Participants (aged 18 to <65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Receives: Biological: Fluzone Quadrivalent vaccine, 2018-2019 formulation
Flublok Quadrivalent vaccine Group 4: 18 to <65 years	Experimental	Participants (aged 18 to <65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0. Receives: Biological: Flublok Quadrivalent vaccine, 2018-2019 formulation
Fluzone High-Dose vaccine Group 5: >=65 years	Experimental	Participants (aged >=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. Receives: Biological: Fluzone High-Dose vaccine, 2018-2019 formulation

What is being measured

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

Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions
A solicited reaction was an adverse event (AE) that was pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection (Inj.) site reactions: tenderness, erythema and swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability.
Measured: Within 7 days post any vaccination
Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions
A solicited reaction was an AE that was pre-listed in the eCRF and considered to be related to vaccination. Solicited injection site reactions: pain, erythema and swelling. Solicited systemic reactions: fever, headache, malaise, and myalgia.
Measured: Within 7 days post any vaccination
Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine
GMT of anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage.
Measured: 28 days post-final vaccination
Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine
GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5.
Measured: Day 21 (post-vaccination)
Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine
GMT of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. GMTRs were calculated as the ratio of GMTs post-final vaccination and pre-vaccination.
Measured: Day 0 (pre-vaccination), 28 days post-final vaccination
Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine
GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.
Measured: Day 0 (pre-vaccination), Day 21 (post-vaccination)
Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Seroprotection was defined as antibody titer >=40 (1/ dilution) at pre-vaccination and at post-final vaccination.
Measured: 28 days post-final vaccination
Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5. Seroprotection was defined as antibody titer >=40 (1/dilution) at pre-vaccination and at post-final vaccination.
Measured: Day 21 (post-vaccination)
Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Seroconversion was defined as either a pre-vaccination titer <10 (1/dilution) and a post-final vaccination titer >= 40 (1/dilution) or a pre-vaccination titer >= 10 (1/dilution) and >=4-fold increase in post-final vaccination titer.
Measured: 28 days post-final vaccination
Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Group 3 and 4, and using an HAI assay for 3 strains: A/H1N1, A/H3N2, and B Victoria lineage in Group 5. Seroconversion was defined as either a pre-vaccination titer <10 (1/dilution) and a post-vaccination titer >= 40 (1/dilution) or a pre-vaccination titer >= 10 (1/dilution) and >=4-fold increase in post-vaccination titer.
Measured: 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.

10 Sep 201812 Nov 2018

First posted6 Aug 2018
Study start10 Sep 2018
Primary completion12 Nov 2018
Study completion12 Nov 2018

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: Randomised
Intervention model: Parallel groups
Model description: The study was partially randomized. Participants were assigned a vaccine group based on age. Participants in Groups 1, 2, and 5 were not randomly assigned, while participants in Groups 3 and 4 were randomly assigned.
Masking: None (open label)
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03617523
Sponsor's protocol ID: GRC90
Other IDs: U1111-1211-4864
Acronym: GRC90
Status last verified: Mar 2022
First submitted: 25 Jul 2018
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, Flublok® Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2018-2019 Formulations
ClinicalTrials.gov ID: NCT03617523
Acronym / sponsor ID: GRC90 / GRC90
Conditions: Influenza
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: 10 Sep 2018 (actual)
Primary completion: 12 Nov 2018 (actual)
Study completion: 12 Nov 2018 (actual)
First posted: 6 Aug 2018 (actual)
Results: Posted 25 Nov 2019

Clinical summary

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

The primary objectives of this study were:

To describe the immunogenicity of the 2018-2019 formulation of Fluzone® Quadrivalent vaccine in children 6 to less than (<) 36 months of age and 3 to <9 years of age, and in adults 18 to <65 years of age; the immunogenicity of the 2018-2019 formulation of Flublok® Quadrivalent vaccine in adults 18 to <65 years of age; and the immunogenicity of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults greater than or equal to (>=) 65 years of age.
To describe the safety of the 2018-2019 formulation of Fluzone Quadrivalent vaccine in children 6 to <36 months of age and 3 to <9 years of age, and in adults 18 to <65 years of age; the safety of the 2018-2019 formulation of Flublok Quadrivalent vaccine in adults 18 to <65 years of age; and the safety of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults >=65 years of age.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5
Model description: The study was partially randomized. Participants were assigned a vaccine group based on age. Participants in Groups 1, 2, and 5 were not randomly assigned, while participants in Groups 3 and 4 were randomly assigned.

Arm	Type	Receives
Fluzone Quadrivalent vaccine Group 1: 6 to <36 months	Experimental	Biological: Fluzone Quadrivalent vaccine, 2018-2019 formulationParticipants (aged 6 to <36 months) received a 0.25-milliliter (mL) dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
Fluzone Quadrivalent vaccine Group 2: 3 to <9 years	Experimental	Biological: Fluzone Quadrivalent vaccine, 2018-2019 formulationParticipants (aged 3 to <9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
Fluzone Quadrivalent vaccine Group 3: 18 to <65 years	Experimental	Biological: Fluzone Quadrivalent vaccine, 2018-2019 formulationParticipants (aged 18 to <65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
Flublok Quadrivalent vaccine Group 4: 18 to <65 years	Experimental	Biological: Flublok Quadrivalent vaccine, 2018-2019 formulationParticipants (aged 18 to <65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
Fluzone High-Dose vaccine Group 5: >=65 years	Experimental	Biological: Fluzone High-Dose vaccine, 2018-2019 formulationParticipants (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 kilograms (kg) (5.5 pounds [lbs.]).
Informed consent form (ICF) had been signed and dated by participants >=18 years of age.
Assent form had been signed and dated by participants 7 to <9 years of age, and ICF had been signed and dated by parent(s) or guardian(s) for participants 6 months to <9 years of age.
Participants 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 (20 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.
Receipt of any vaccine in the 30 days preceding the first study vaccination, or planned receipt of any vaccine before Visit 2 for participants who received 1 dose of influenza vaccine or Visit 3 for participants who received 2 doses of influenza vaccine.
Previous vaccination against influenza (in the 2018-2019 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 vaccine, 2018-2019 formulationPharmaceutical form: Suspension for injection Route of administration: Intramuscular	Biological	Fluzone Quadrivalent vaccine Group 1: 6 to <36 months, Fluzone Quadrivalent vaccine Group 2: 3 to <9 years, Fluzone Quadrivalent vaccine Group 3: 18 to <65 years
Flublok Quadrivalent vaccine, 2018-2019 formulationPharmaceutical form: Suspension for injection Route of administration: Intramuscular	Biological	Flublok Quadrivalent vaccine Group 4: 18 to <65 years
Fluzone High-Dose vaccine, 2018-2019 formulationPharmaceutical form: Suspension for injection Route of administration: Intramuscular	Biological	Fluzone High-Dose vaccine Group 5: >=65 years

Primary outcome

Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions
Time frame: Within 7 days post any vaccination
A solicited reaction was an adverse event (AE) that was pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection (Inj.) site reactions: tenderness, erythema and swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability.
Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions
Time frame: Within 7 days post any vaccination
A solicited reaction was an AE that was pre-listed in the eCRF and considered to be related to vaccination. Solicited injection site reactions: pain, erythema and swelling. Solicited systemic reactions: fever, headache, malaise, and myalgia.
Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine
Time frame: 28 days post-final vaccination
GMT of anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage.
Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine
Time frame: Day 21 (post-vaccination)
GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5.
Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine
Time frame: Day 0 (pre-vaccination), 28 days post-final vaccination
GMT of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. GMTRs were calculated as the ratio of GMTs post-final vaccination and pre-vaccination.
Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine
Time frame: Day 0 (pre-vaccination), Day 21 (post-vaccination)
GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.
Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2
Time frame: 28 days post-final vaccination
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Seroprotection was defined as antibody titer >=40 (1/ dilution) at pre-vaccination and at post-final vaccination.
Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5
Time frame: Day 21 (post-vaccination)
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5. Seroprotection was defined as antibody titer >=40 (1/dilution) at pre-vaccination and at post-final vaccination.
Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2
Time frame: 28 days post-final vaccination
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Seroconversion was defined as either a pre-vaccination titer <10 (1/dilution) and a post-final vaccination titer >= 40 (1/dilution) or a pre-vaccination titer >= 10 (1/dilution) and >=4-fold increase in post-final vaccination titer.
Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5
Time frame: Day 21 (post-vaccination)
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Group 3 and 4, and using an HAI assay for 3 strains: A/H1N1, A/H3N2, and B Victoria lineage in Group 5. Seroconversion was defined as either a pre-vaccination titer <10 (1/dilution) and a post-vaccination titer >= 40 (1/dilution) or a pre-vaccination titer >= 10 (1/dilution) and >=4-fold increase in post-vaccination titer.

Results and safety

Results posted to the registry on 25 Nov 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
Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months	30	30
Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years	30	30
Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years	61	61
Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years	59	59
Fluzone High-Dose Vaccine Group 5: >=65 Years	60	60

Primary outcome: Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions

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

Measure	Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months n = 29
Injection site tenderness	15
Injection site erythema	3
Injection site swelling	4
Fever	2
Vomiting	3
Crying abnormal	4
Drowsiness	9
Appetite lost	10

Population analysed: Analysis was performed on safety analysis set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Primary outcome: Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions

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

Measure	Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years n = 30	Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years n = 61	Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years n = 59	Fluzone High-Dose Vaccine Group 5: >=65 Years n = 60
Injection site pain	9	27	22	24
Injection site erythema	5	1	0	5
Injection site swelling	6	2	0	3
Fever	1	0	0	0
Headache	5	12	13	11
Malaise	6	11	6	9
Myalgia	6	14	11	15

Population analysed: Analysis was performed on safety analysis set.

Primary outcome: Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine

Time frame: 28 days post-final vaccination. Geometric mean (95% Confidence Interval). Unit: titers (1/dilution)

Measure	Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months n = 26	Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years n = 29
A/H1N1	229 (108 to 487)	1008 (605 to 1680)
A/H3N2	239 (94.0 to 606)	1109 (671 to 1833)
B Victoria	160 (79.3 to 323)	688 (390 to 1211)
B Yamagata	295 (167 to 524)	1343 (811 to 2223)

Population analysed: Analysis was performed on per-protocol analysis set which included participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result for at least 1 strain without any protocol deviations.

Primary outcome: Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine

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

Measure	Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years n = 61	Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years n = 58	Fluzone High-Dose Vaccine Group 5: >=65 Years n = 60
A/H1N1	525 (386 to 712)	708 (498 to 1007)	266 (195 to 363)
A/H3N2	379 (276 to 523)	644 (456 to 909)	359 (255 to 507)
B Victoria	588 (447 to 773)	525 (388 to 711)	453 (337 to 608)
B Yamagata	759 (571 to 1009)	1102 (829 to 1465)	NA (NA to NA)

Population analysed: Analysis was performed on per-protocol analysis set.

Adverse events

Time frame: Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months	0 of 30 (0%)	21 of 30 (70%)	0 of 30
Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years	0 of 30 (0%)	13 of 30 (43.3%)	0 of 30
Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years	0 of 61 (0%)	33 of 61 (54.1%)	0 of 61
Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years	0 of 59 (0%)	29 of 59 (49.2%)	0 of 59
Fluzone High-Dose Vaccine Group 5: >=65 Years	0 of 60 (0%)	34 of 60 (56.7%)	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.
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.

Clinical Sciences & Operations 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?

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 20 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 25 Nov 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?

Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions (time frame: Within 7 days post 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 NCT03617523.

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.