InfluenzaPhase 4NCT02908269
Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations
A Phase 4 study testing Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative and Fluzone High-Dose, vaccine, 2016-2017 formulation in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 2 sites in United States.
Trial summary
The aim of the study was to describe the safety and immunogenicity of the 2016-2017 formulations of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and in adults 18 to < 65 years or age, and of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥65 years of age. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative and Fluzone High-Dose, vaccine, 2016-2017 formulation
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2016to 9 Dec 2016
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Aged 3 to <9 years or adult aged ≥ 18 years on the day of first study vaccination (study product administration) .
- Informed consent form 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 informed consent form (ICF) has been signed and dated by parent(s) or guardian(s) for participants 3 to <9 years of age.
- Participant and parent/guardian (of participants 3 to <9 years of age) were able to attend all scheduled visits and to comply with all trial 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 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 30 days preceding the first trial 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 2016-2017 influenza season) with either the trial vaccine or another vaccine.
- 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).
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- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
- 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, 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 planned vaccination or febrile illness (temperature ≥100.4°F [38.0°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
2 sites in 1 country.
United States2 sites
Study site
Bardstown, Kentucky, 40004
Study site
Metairie, Louisiana, 70002
About this study
The aim of the study was to describe the safety and immunogenicity of the 2016-2017 formulations of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and in adults 18 to < 65 years or age, and of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥65 years of age.
Primary Observational Objectives
Read more
- To describe the safety of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and adults 18 to < 65 years of age, and the safety of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.
Observational Objectives:
- To describe the immunogenicity of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and adults 18 to < 65 years of age, and the immunogenicity of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.
- To submit available sera from approximately 90 participants (30 participants 3 to < 9 years of age and 30 participants 18 to < 65 years of age who receive Fluzone Quadrivalent vaccine, and 30 participants ≥ 65 years of age who receive Fluzone High-Dose vaccine) to Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
Read the detailed description
All participants received a 0.5-mL intramuscular dose of their assigned vaccine at Visit 1. For participants 3 to < 9 years of age for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine (of the same volume) was administered during Visit 2.
Solicited adverse reaction (AR) information was collected for 7 days after 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 on Day 28 for 3 to < 9 year olds and Day 21 days for adults 18 years and older.
- Conditions
- Influenza
- Being tested
- Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative, Fluzone High-Dose, vaccine, 2016-2017 formulation
- Keywords
- Influenza, Fluzone® Quadrivalent, Influenza Vaccine (2016-2017 formulation), Fluzone® High-Dose, Influenza Vaccine (2016-2017 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, 2016-2017 formulation, No PreservativeBiological
Also called Fluzone® Quadrivalent, Influenza Vaccine
0.5 mL, Intramuscular
Fluzone Quadrivalent vaccine, 2016-2017 formulation, No PreservativeBiological
Also called Fluzone® Quadrivalent, Influenza Vaccine
0.5 mL, Intramuscular
Fluzone High-Dose, vaccine, 2016-2017 formulationBiological
Also called Fluzone® High-Dose Influenza Vaccine
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Fluzone Quadrivalent Vaccine Group 1: 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. For participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28. Receives: Biological: Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative |
| Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years | Experimental | Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Receives: Biological: Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative |
| Fluzone High-Dose Vaccine Group 3: ≥ 65 Years | Experimental | Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. Receives: Biological: Fluzone High-Dose, vaccine, 2016-2017 formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age)
Solicited injection site reactions: Pain (Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: incapacitating, unable to perform usual activities), erythema \& swelling (Grade 1: >0 to <25 mm;Grade 2: ≥ 25 to < 50 mm; Grade 3: ≥ 50 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise \& myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site \& systemic reactions are reported; number of participants with Grade 3 solicited injection-site \& systemic reactions are also reported.
Measured: Within 7 days after any vaccination
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years)
Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant; prevents daily activity), erythema \& swelling (Grade 1: ≥ 25 to ≤ 50 mm; Grade 2: ≥ 51 to ≤ 100 mm; Grade 3: >100 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise \& myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site \& systemic reactions are reported; number of participants with Grade 3 solicited injection-site \& systemic reactions are also reported.
Measured: Within 7 days after any vaccination
Secondary outcomes (6)
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 1: 3 to < 9 Years)
Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage.
Measured: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 2: 18 to < 65 Years)
Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage.
Measured: Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 3: ≥ 65 Years)
Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 3 strains: H1N1, H3N2, Victoria lineage.
Measured: Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 1: 3 to < 9 Years)
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage. Seroprotection was defined as an antibody titer ≥40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination.
Measured: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 2: 18 to < 65 Years)
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage. Seroprotection was defined as an antibody titer ≥ 40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination.
Measured: Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 3: ≥ 65 Years)
Anti-influenza antibodies were measured using HAI assay for 3 strains: H1N1, H3N2, Victoria lineage. Seroprotection was defined as an antibody titer ≥ 40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination.
Measured: Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start15 Sep 2016
- Primary completion9 Dec 2016
- Study completion9 Dec 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.
- 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
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908269
- Sponsor's protocol ID
- GRC71
- Other IDs
- U1111-1174-4738
- Status last verified
- Mar 2022
- First submitted
- 16 Sep 2016
- 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
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, 2016-2017 Formulations
- ClinicalTrials.gov ID
- NCT02908269
- Acronym / sponsor ID
- GRC71
- Conditions
- Influenza
- Keywords
- Influenza, Fluzone® Quadrivalent, Influenza Vaccine (2016-2017 formulation), Fluzone® High-Dose, Influenza Vaccine (2016-2017 formulation)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2016
- Primary completion
- 9 Dec 2016 (actual)
- Study completion
- 9 Dec 2016 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Posted 8 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study was to describe the safety and immunogenicity of the 2016-2017 formulations of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and in adults 18 to < 65 years or age, and of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥65 years of age.
Primary Observational Objectives
- To describe the safety of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and adults 18 to < 65 years of age, and the safety of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.
Observational Objectives:
- To describe the immunogenicity of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and adults 18 to < 65 years of age, and the immunogenicity of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.
- To submit available sera from approximately 90 participants (30 participants 3 to < 9 years of age and 30 participants 18 to < 65 years of age who receive Fluzone Quadrivalent vaccine, and 30 participants ≥ 65 years of age who receive Fluzone High-Dose vaccine) to Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
Detailed description
All participants received a 0.5-mL intramuscular dose of their assigned vaccine at Visit 1. For participants 3 to < 9 years of age for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine (of the same volume) was administered during Visit 2.
Solicited adverse reaction (AR) information was collected for 7 days after 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 on Day 28 for 3 to < 9 year olds and Day 21 days for adults 18 years and older.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years | Experimental | Biological: Fluzone Quadrivalent vaccine, 2016-2017 formulation, No PreservativeParticipants 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 per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28. |
| Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years | Experimental | Biological: Fluzone Quadrivalent vaccine, 2016-2017 formulation, No PreservativeParticipants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. |
| Fluzone High-Dose Vaccine Group 3: ≥ 65 Years | Experimental | Biological: Fluzone High-Dose, vaccine, 2016-2017 formulationParticipants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 3 to <9 years or adult aged ≥ 18 years on the day of first study vaccination (study product administration) .
- Informed consent form 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 informed consent form (ICF) has been signed and dated by parent(s) or guardian(s) for participants 3 to <9 years of age.
- Participant and parent/guardian (of participants 3 to <9 years of age) were able to attend all scheduled visits and to comply with all trial 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 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 30 days preceding the first trial 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 2016-2017 influenza season) with either the trial vaccine or another vaccine.
- 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 |
|---|---|---|
| Fluzone Quadrivalent vaccine, 2016-2017 formulation, No PreservativeAlso: Fluzone® Quadrivalent, Influenza Vaccine0.5 mL, Intramuscular | Biological | Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years |
| Fluzone Quadrivalent vaccine, 2016-2017 formulation, No PreservativeAlso: Fluzone® Quadrivalent, Influenza Vaccine0.5 mL, Intramuscular | Biological | Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years |
| Fluzone High-Dose, vaccine, 2016-2017 formulationAlso: Fluzone® High-Dose Influenza Vaccine0.5 mL, Intramuscular | Biological | Fluzone High-Dose Vaccine Group 3: ≥ 65 Years |
Primary outcome
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age)
Time frame: Within 7 days after any vaccination
Solicited injection site reactions: Pain (Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: incapacitating, unable to perform usual activities), erythema \& swelling (Grade 1: >0 to <25 mm;Grade 2: ≥ 25 to < 50 mm; Grade 3: ≥ 50 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise \& myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site \& systemic reactions are reported; number of participants with Grade 3 solicited injection-site \& systemic reactions are also reported.
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years)
Time frame: Within 7 days after any vaccination
Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant; prevents daily activity), erythema \& swelling (Grade 1: ≥ 25 to ≤ 50 mm; Grade 2: ≥ 51 to ≤ 100 mm; Grade 3: >100 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise \& myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site \& systemic reactions are reported; number of participants with Grade 3 solicited injection-site \& systemic reactions are also reported.
6 secondary outcomes
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 1: 3 to < 9 Years)
Time frame: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 2: 18 to < 65 Years)
Time frame: Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 3: ≥ 65 Years)
Time frame: Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 1: 3 to < 9 Years)
Time frame: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 2: 18 to < 65 Years)
Time frame: Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)
Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 3: ≥ 65 Years)
Time frame: Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)
Results and safety
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 Inc.
2 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, 2016-2017 formulation, No Preservative and Fluzone High-Dose, vaccine, 2016-2017 formulation in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 2 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 4 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 2 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 8 Jan 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 Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age) (time frame: Within 7 days after any vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.