InfluenzaPhase 3NCT03282240

Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US

A Phase 3 study testing QIV-HD, Licensed TIV-HD1 and Investigational TIV-HD2 in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 36 sites in United States.

Completed

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

Official record

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Trial summary

This randomized, modified double-blind, active-controlled, multi-center trial assessed the safety and immunogenicity of the high-dose quadrivalent influenza vaccine (QIV-HD) compared to either the licensed or investigational high-dose trivalent influenza vaccine (TIV-HD) in adults. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: QIV-HD, Licensed TIV-HD1 and Investigational TIV-HD2
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,670 participants
Where: 36 sitesUnited States
Study dates: 8 Sep 2017to 19 Apr 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Aged >= 65 years on the day of inclusion.
Informed consent form had been signed and dated.
Able to attend all scheduled visits and to comply with all trial procedures.

Who cannot join

Participation at the time of trial enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2.
Previous vaccination against influenza (in the preceding 6 months) 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).
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.

Show all 14Show fewer

Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on investigator's judgment.
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
Alcohol or substance abuse that, in the opinion of the investigator, might interfere with the trial conduct or completion.
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, 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 trial.
Personal or family history of Guillain-Barré syndrome.
Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy and participants who have a history of neoplastic disease and have been disease free for >= 5 years).
Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0°C [>= 100.4°F]). A prospective participant should not be included in the trial until the condition has resolved or the febrile event had subsided.

Trial locations and contacts

36 sites in 1 country.

City, postcode or hospital

36 sites in 1 country

United States36 sites

Sanofi Pasteur Investigational Site 037
Anaheim, California, 92801
Sanofi Pasteur Investigational Site 012
Bardstown, Kentucky, 40004
Sanofi Pasteur Investigational Site 026
Biloxi, Mississippi, 39531
Sanofi Pasteur Investigational Site 010
Boise, Idaho, 83712
Sanofi Pasteur Investigational Site 004
Cleveland, Ohio, 44122
Sanofi Pasteur Investigational Site 016
Colorado Springs, Colorado, 80920
Sanofi Pasteur Investigational Site 021
Council Bluffs, Iowa, 51501
Sanofi Pasteur Investigational Site 002
Dallas, Texas, 75234
Sanofi Pasteur Investigational Site 031
Hollywood, Florida, 33024
Sanofi Pasteur Investigational Site 009
Jacksonville, Florida, 32205
Sanofi Pasteur Investigational Site 017
Jacksonville, Florida, 32216
Sanofi Pasteur Investigational Site 024
Las Vegas, Nevada, 89104
Sanofi Pasteur Investigational Site 034
Meridian, Idaho, 83642
Sanofi Pasteur Investigational Site 018
Metairie, Louisiana, 70427
Sanofi Pasteur Investigational Site 035
Milford, Connecticut, 06460
Sanofi Pasteur Investigational Site 033
Mt. Pleasant, South Carolina, 29464
Sanofi Pasteur Investigational Site 001
Nashville, Tennessee, 37212
Sanofi Pasteur Investigational Site 038
Norfolk, Virginia, 23507
Sanofi Pasteur Investigational Site 015
Oklahoma City, Oklahoma, 73112
Sanofi Pasteur Investigational Site 011
Omaha, Nebraska, 68134
Sanofi Pasteur Investigational Site 029
Redding, California, 96001
Sanofi Pasteur Investigational Site 008
Rochester, New York, 14609
Sanofi Pasteur Investigational Site 027
Salt Lake City, Utah, 84109
Sanofi Pasteur Investigational Site 006
Salt Lake City, Utah, 84121
Sanofi Pasteur Investigational Site 019
Salt Lake City, Utah, 84123
Sanofi Pasteur Investigational Site 003
San Diego, California, 92117
Sanofi Pasteur Investigational Site 020
South Jordan, Utah, 84095
Sanofi Pasteur Investigational Site 014
St Louis, Missouri, 63104
Sanofi Pasteur Investigational Site 030
Stockbridge, Georgia, 30281
Sanofi Pasteur Investigational Site 025
Tomball, Texas, 77375
Sanofi Pasteur Investigational Site 013
Warwick, Rhode Island, 02886
Sanofi Pasteur Investigational Site 022
West Jordan, Utah, 83642
Sanofi Pasteur Investigational Site 023
Wichita, Kansas, 67205
Sanofi Pasteur Investigational Site 028
Wichita, Kansas, 67207
Sanofi Pasteur Investigational Site 005
Wilmington, North Carolina, 28401
Sanofi Pasteur Investigational Site 036
Winston-Salem, North Carolina, 27045

Other trials in United States

About this study

Official title: Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular Route in Participants Aged 65 Years and Older

Read the detailed description

This randomized, modified double-blind, active-controlled, multi-center trial was conducted in healthy adults (greater than and equal to [>=] 65 years) to assess the safety and immunogenicity (geometric mean titers and seroconversion for the 4 virus strains at 28 days post vaccination) of the QIV-HD compared to one of the TIV-HDs containing either the B strain from the primary lineage (TIV-HD1; licensed vaccine [Fluzone® High-Dose] for the 2017-2018 Northern Hemisphere [NH] influenza season) or the B strain from the alternate lineage (TIV-HD2, investigational TIV-HD containing an alternate B strain).

Conditions: Influenza
Being tested: QIV-HD, Licensed TIV-HD1, Investigational TIV-HD2
Keywords: Influenza
Medical subject headings: Influenza, Human

What participants receive

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

QIV-HDBiological
Also called High-dose quadrivalent influenza vaccine
0.7 mL-dose was administered intramuscularly (IM) into the upper arm area.
Licensed TIV-HD1Biological
Also called High-dose trivalent influenza vaccine
0.5 mL-dose was administered IM into the upper arm area.
Investigational TIV-HD2Biological
Also called High-dose trivalent influenza vaccine (alternate B strain)
0.5 mL-dose was administered IM into the upper arm area.

Study groups in NCT03282240
Study group	Role	What they receive
QIV-HD	Experimental	Participants randomized to receive a single injection of 0.7 mL QIV-HD by intramuscular (IM) route at Day 0. Receives: Biological: QIV-HD
TIV-HD1 (Licensed TIV-HD1)	Active comparator	Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0. Receives: Biological: Licensed TIV-HD1
TIV-HD2 (Investigational TIV-HD2)	Active comparator	Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0. Receives: Biological: Investigational TIV-HD2

What is being measured

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

Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
GMTs of anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.
Measured: Day 28 post-vaccination
Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Seroconversion was defined as either a HAI titer less than (<) 10 (1/dilution) at Day 0 and post-injection titer greater than or equal to (>=) 40 (1/dilution) at Day 28, or HAI titer >=10 (1/dilution) at Day 0 and a >=4-fold increase in HAI titer (1/dilution) at Day 28. For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.
Measured: Day 28 post-vaccination

Secondary outcomes (13)

GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). For each B strain, the immunogenicity of QIV-HD was compared to that of TIV-HD group which contains the corresponding B strain. TIV-HD1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.
Measured: Day 28 post-vaccination
GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
GMTs of anti-influenza antibodies using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Geometric Mean Titers Ratios (GMTRs) were calculated as the ratio of GMTs post vaccination and pre-vaccination.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants Achieving Seroconversion Against Antigens of B Strains After Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Seroconversion was defined as either a HAI titer <10 (1/dilution) at Day 0 and post-injection titer >=40 (1/dilution) at Day 28, or HAI titer >=10 (1/dilution) at Day 0 and a >=4-fold increase in HAI titer (1/dilution) at Day 28.
Measured: Day 28 post-vaccination
Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). Seroprotection was defined as a HAI titer >=40 (1/dilution) at Day 0 and Day 28.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
GMTs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2).
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
GMTRs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28
Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Neutralizing antibody was defined as titers >=20 (1/dilution), >=40 (1/dilution), >=80 (1/dilution) at Day 0 and Day 28.
Measured: Day 0, Day 28
Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28
Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). 2-fold and 4-fold rise was defined as the computed value = post-vaccination computed value / baseline computed value.
Measured: Day 28
Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28
Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Detectable neutralization antibody titer >= 1:10 (1/dilution) at Day 0 and Day 28.
Measured: Day 0, Day 28
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Solicited injection site: Pain, Erythema, Swelling, Induration, and Bruising. Grade 3 reactions: Pain - interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention; Erythema, Swelling, Induration, and Bruising: >100 millimeters (mm). Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 reactions: Fever: >=39°C; Headache, Malaise, Myalgia, and Shivering: interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Measured: Within 7 days after vaccination
Number of Participants With Immediate Adverse Event (AEs)
Participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurring during that time was recorded as immediate unsolicited systemic AEs (AEs that were related to the investigational product) in the case report book (CRB). Unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/ or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
Measured: Within 30 minutes after vaccination
Number of Participant With Unsolicited Adverse Event (AE)
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
Measured: Within 28 days after vaccination
Number of Participant With Serious Adverse Event
An serious adverse event was any untoward medical occurrence that at any dose results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity,is a congenital anomaly/birth defect, or was an important medical event.
Measured: Up to 6 months after vaccination

Timeline

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

8 Sep 201719 Apr 2018

First posted13 Sep 2017
Study start8 Sep 2017
Primary completion2 Nov 2017
Study completion19 Apr 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: QHD00013 was a phase III, randomized, modified double-blind, active-controlled, multi-center trial.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 2,670 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03282240
Sponsor's protocol ID: QHD00013
Other IDs: U1111-1183-5556
Status last verified: Mar 2022
First submitted: 12 Sep 2017
Last updated: 7 Apr 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

Publications

Chang LJ, Meng Y, Janosczyk H, Landolfi V, Talbot HK; QHD00013 Study Group. Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults >/=65 years of age: A phase 3 randomized clinical trial. Vaccine. 2019 Sep 16;37(39):5825-5834. doi: 10.1016/j.vaccine.2019.08.016. Epub 2019 Aug 17.
PubMed 31431411

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 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular Route in Participants Aged 65 Years and Older
ClinicalTrials.gov ID: NCT03282240
Acronym / sponsor ID: QHD00013
Conditions: Influenza
Keywords: Influenza
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,670 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 8 Sep 2017 (actual)
Primary completion: 2 Nov 2017 (actual)
Study completion: 19 Apr 2018 (actual)
First posted: 13 Sep 2017 (actual)
Results: Posted 17 Dec 2019

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: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3
Model description: QHD00013 was a phase III, randomized, modified double-blind, active-controlled, multi-center trial.

Arm	Type	Receives
QIV-HD	Experimental	Biological: QIV-HDParticipants randomized to receive a single injection of 0.7 mL QIV-HD by intramuscular (IM) route at Day 0.
TIV-HD1 (Licensed TIV-HD1)	Active comparator	Biological: Licensed TIV-HD1Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
TIV-HD2 (Investigational TIV-HD2)	Active comparator	Biological: Investigational TIV-HD2Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

Aged >= 65 years on the day of inclusion.
Informed consent form had been signed and dated.
Able to attend all scheduled visits and to comply with all trial procedures.

Key exclusion criteria (14 listed)

Participation at the time of trial enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2.
Previous vaccination against influenza (in the preceding 6 months) 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).

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
QIV-HDAlso: High-dose quadrivalent influenza vaccine0.7 mL-dose was administered intramuscularly (IM) into the upper arm area.	Biological	QIV-HD
Licensed TIV-HD1Also: High-dose trivalent influenza vaccine0.5 mL-dose was administered IM into the upper arm area.	Biological	TIV-HD1 (Licensed TIV-HD1)
Investigational TIV-HD2Also: High-dose trivalent influenza vaccine (alternate B strain)0.5 mL-dose was administered IM into the upper arm area.	Biological	TIV-HD2 (Investigational TIV-HD2)

Primary outcome

Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Time frame: Day 28 post-vaccination
GMTs of anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.
Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Time frame: Day 28 post-vaccination
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Seroconversion was defined as either a HAI titer less than (<) 10 (1/dilution) at Day 0 and post-injection titer greater than or equal to (>=) 40 (1/dilution) at Day 28, or HAI titer >=10 (1/dilution) at Day 0 and a >=4-fold increase in HAI titer (1/dilution) at Day 28. For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.

13 secondary outcomes

GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Time frame: Day 28 post-vaccination
GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants Achieving Seroconversion Against Antigens of B Strains After Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Time frame: Day 28 post-vaccination
Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28
Time frame: Day 0, Day 28
Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28
Time frame: Day 28
Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28
Time frame: Day 0, Day 28
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Time frame: Within 7 days after vaccination
Number of Participants With Immediate Adverse Event (AEs)
Time frame: Within 30 minutes after vaccination
Number of Participant With Unsolicited Adverse Event (AE)
Time frame: Within 28 days after vaccination
Number of Participant With Serious Adverse Event
Time frame: Up to 6 months after vaccination

Results and safety

Results posted to the registry on 17 Dec 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
High-Dose Quadrivalent Influenza Vaccine (QIV-HD)	1,777	1,767
High-Dose Trivalent Influenza Vaccine (Licensed TIV-HD1)	443	440
High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)	450	447

Primary outcome: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine

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

Measure	High-Dose Quadrivalent Influenza Vaccine (QIV-HD) n = 1680	High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) n = 423	High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) n = 430	High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled) n = 853
A/H1N1	312 (292 to 332)	387 (339 to 442)	362 (317 to 413)	374 (341 to 411)
A/H3N2	563 (525 to 603)	588 (513 to 673)	600 (524 to 687)	594 (540 to 653)
B Victoria	516 (488 to 545)	476 (426 to 532)	–	–
B Yamagata	578 (547 to 612)	–	580 (519 to 649)	–

High-Dose Quadrivalent Influenza Vaccine (QIV-HD) vs High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1): GMT Ratio (QIV-HD/TIV-HDs): 1.08 (95% CI 0.958 to 1.224)
High-Dose Quadrivalent Influenza Vaccine (QIV-HD) vs High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2): GMT Ratio (QIV-HD/TIV-HDs): 1.00 (95% CI 0.881 to 1.129)
High-Dose Quadrivalent Influenza Vaccine (QIV-HD) vs High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled): GMT Ratio (QIV-HD/TIV-HDs): 0.83 (95% CI 0.744 to 0.932)

Population analysed: Per-protocol analysis set (PPAS): all randomized participants who received at least 1 dose of trial vaccine \& had a post-vaccination blood sample HAI result for at least 1 strain, with no relevant protocol deviations. Here, 'number analyzed' = participants with available data for each category.

Primary outcome: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine

Time frame: Day 28 post-vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	High-Dose Quadrivalent Influenza Vaccine (QIV-HD) n = 1680	High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) n = 423	High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) n = 430	High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled) n = 853
A/H1N1	50.4 (48.0 to 52.8)	56.2 (51.3 to 61.0)	51.2 (46.3 to 56.0)	53.7 (50.2 to 57.1)
A/H3N2	49.8 (47.3 to 52.2)	52.9 (48.0 to 57.7)	48.1 (43.3 to 53.0)	50.5 (47.1 to 53.9)
B Victoria	36.5 (34.2 to 38.9)	39.0 (34.3 to 43.8)	–	–
B Yamagata	46.6 (44.2 to 49.0)	–	48.4 (43.5 to 53.2)	–

High-Dose Quadrivalent Influenza Vaccine (QIV-HD) vs High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1): Difference in Percentage: -2.41 (95% CI -7.66 to 2.70)
High-Dose Quadrivalent Influenza Vaccine (QIV-HD) vs High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2): Difference in Percentage: -1.75 (95% CI -7.04 to 3.53)
High-Dose Quadrivalent Influenza Vaccine (QIV-HD) vs High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled): Difference in Percentage: -0.71 (95% CI -4.83 to 3.42)

Population analysed: Analysis was performed on PPAS. Here, 'number analyzed' = participants with available data for each category.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from Day 0 (post-vaccination) up to 28 days after last vaccination. Solicited Reaction (SR) data were collected up to Day 7 after each vaccination. Serious adverse event data were collected throughout the study (up to 180 days after last vaccination).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High-Dose Quadrivalent Influenza Vaccine (QIV-HD)	80 of 1,777 (4.5%)	935 of 1,777 (52.6%)	3 of 1,777
High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)	29 of 443 (6.5%)	234 of 443 (52.8%)	2 of 443
High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)	19 of 450 (4.2%)	206 of 450 (45.8%)	0 of 450

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31431411Chang LJ, Meng Y, Janosczyk H, Landolfi V, Talbot HK; QHD00013 Study Group. Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults >/=65 years of age: A phase 3 randomized clinical trial. Vaccine. 2019 Sep 16;37(39):5825-5834. doi: 10.1016/j.vaccine.2019.08.016. Epub 2019 Aug 17.
Related infoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QIV-HD, Licensed TIV-HD1 and Investigational TIV-HD2 in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 36 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 3 inclusion and 14 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 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 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?

Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine (time frame: Day 28 post-vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03282240, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.