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CompletedNCT03282240Updated Apr 7, 2022Results posted

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

A Phase 3 interventional study of QIV-HD and Licensed TIV-HD1 in Influenza, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 36 sites in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-07.

Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
2,670
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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 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).

02

Conditions studied

  • Influenza

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Keywords

  • Influenza
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
04

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
2,670 participants (actual)

Study arms

  • Experimental
    QIV-HD

    Participants randomized to receive a single injection of 0.7 mL QIV-HD by intramuscular (IM) route at Day 0.

    Biological: QIV-HD

  • Active comparator
    TIV-HD1 (Licensed TIV-HD1)

    Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.

    Biological: Licensed TIV-HD1

  • Active comparator
    TIV-HD2 (Investigational TIV-HD2)

    Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.

    Biological: Investigational TIV-HD2

Interventions

  • BiologicalQIV-HD

    0.7 mL-dose was administered intramuscularly (IM) into the upper arm area.

    Also known as: High-dose quadrivalent influenza vaccine

  • BiologicalLicensed TIV-HD1

    0.5 mL-dose was administered IM into the upper arm area.

    Also known as: High-dose trivalent influenza vaccine

  • BiologicalInvestigational TIV-HD2

    0.5 mL-dose was administered IM into the upper arm area.

    Also known as: High-dose trivalent influenza vaccine (alternate B strain)

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 28 post-vaccination

  2. 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.

    Time frame: Day 28 post-vaccination

Secondary outcomes

  1. 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.

    Time frame: Day 28 post-vaccination

  2. 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.

    Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination

  3. 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.

    Time frame: Day 28 post-vaccination

  4. 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.

    Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination

  5. 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).

    Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination

  6. 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.

    Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination

  7. 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.

    Time frame: Day 0, Day 28

  8. 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.

    Time frame: Day 28

  9. 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.

    Time frame: Day 0, Day 28

  10. 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.

    Time frame: Within 7 days after vaccination

  11. 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.

    Time frame: Within 30 minutes after vaccination

  12. 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.

    Time frame: Within 28 days after vaccination

  13. 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.

    Time frame: Up to 6 months after vaccination

06

Results

Posted Dec 17, 2019

Participant flow

Study participants were screened in 35 centers in the Unites States (US) from 08 September 2017 to 15 September 2017.

Participant flow — Overall Study
MilestoneHigh-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccine (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Started1777443450
Completed1767440447
Not completed1033
Withdrew: Adverse event220
Withdrew: Lost to follow-up300
Withdrew: Protocol deviation412
Withdrew: Withdrawal by subject101

Outcome measures

PrimaryGeometric 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.

Time frame:
Day 28 post-vaccination
Reported as:
Geometric mean · titers (1/dilution)
Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
titers (1/dilution)High-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled)
A/H1N1312 (292 to 332)387 (339 to 442)362 (317 to 413)374 (341 to 411)
A/H3N2563 (525 to 603)588 (513 to 673)600 (524 to 687)594 (540 to 653)
B Victoria516 (488 to 545)476 (426 to 532)——
B Yamagata578 (547 to 612)—580 (519 to 649)—
Statistical analysis
  • 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
  • High-Dose Quadrivalent Influenza Vaccine (QIV-HD) vs High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled) · Gmt ratio (qiv-hd/tiv-hds): 0.95 · 95% CI 0.842 to 1.066
PrimaryPercentage 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.

Time frame:
Day 28 post-vaccination
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
percentage of participantsHigh-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled)
A/H1N150.4 (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/H3N249.8 (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 Victoria36.5 (34.2 to 38.9)39.0 (34.3 to 43.8)——
B Yamagata46.6 (44.2 to 49.0)—48.4 (43.5 to 53.2)—
Statistical analysis
  • 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
  • High-Dose Quadrivalent Influenza Vaccine (QIV-HD) vs High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled) · Difference in percentage: -3.27 · 95% CI -7.37 to 0.86
SecondaryGMTs 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.

Time frame:
Day 28 post-vaccination
Reported as:
Geometric mean · titers (1/dilution)
GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
titers (1/dilution)High-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
B Victoria515 (488 to 543)—253 (227 to 283)
B Yamagata573 (542 to 605)280 (249 to 316)—
Statistical analysis
  • High-Dose Quadrivalent Influenza Vaccine (QIV-HD) vs High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) · Gmt ratio (qiv-hd/tiv-hds): 2.04 · 95% CI 1.804 to 2.315
  • High-Dose Quadrivalent Influenza Vaccine (QIV-HD) vs High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) · Gmt ratio (qiv-hd/tiv-hds): 2.03 · 95% CI 1.802 to 2.288
SecondaryGMT 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.

Time frame:
Day 0 (pre-vaccination) and Day 28 post-vaccination
Reported as:
Number · ratio
GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
ratioHigh-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
A/H1N1: Day28/Day 04.38 (4.11 to 4.66)5.57 (4.85 to 6.39)4.76 (4.16 to 5.44)
A/H3N2: Day28/Day 04.65 (4.35 to 4.98)4.82 (4.24 to 5.48)4.94 (4.32 to 5.65)
B Victoria: Day28/Day 03.17 (2.99 to 3.35)3.35 (2.99 to 3.76)1.65 (1.52 to 1.78)
B Yamagata: Day28/Day 03.82 (3.62 to 4.03)1.86 (1.73 to 2.02)3.82 (3.43 to 4.24)
SecondaryPercentage 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.

Time frame:
Day 28 post-vaccination
Reported as:
Number · percentage of participants
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
percentage of participantsHigh-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
B Victoria36.3 (34.1 to 38.6)—15.5 (12.3 to 19.3)
B Yamagata46.7 (44.3 to 49.0)17.4 (14.0 to 21.3)—
Statistical analysis
  • High-Dose Quadrivalent Influenza Vaccine (QIV-HD) vs High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) · Difference in percentage: 29.27 · 95% CI 24.78 to 33.29
  • High-Dose Quadrivalent Influenza Vaccine (QIV-HD) vs High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) · Difference in percentage: 20.78 · 95% CI 16.5 to 24.61
SecondaryPercentage 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.

Time frame:
Day 0 (pre-vaccination) and Day 28 post-vaccination
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
percentage of participantsHigh-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
A/H1N1: Day 069.4 (67.2 to 71.6)67.9 (63.2 to 72.3)70.1 (65.5 to 74.4)
A/H3N2: Day 077.4 (75.3 to 79.4)78.1 (73.8 to 82.0)77.8 (73.6 to 81.7)
B Victoria: Day 088.9 (87.2 to 90.3)87.9 (84.4 to 90.8)88.8 (85.4 to 91.6)
B Yamagata : Day 089.6 (88.0 to 91.0)88.1 (84.6 to 91.1)90.9 (87.8 to 93.4)
A/H1N1: Day 2895.1 (94.0 to 96.1)96.7 (94.5 to 98.2)95.6 (93.2 to 97.3)
A/H3N2: Day 2896.9 (96.0 to 97.7)96.9 (94.8 to 98.4)96.7 (94.6 to 98.2)
B Victoria: Day 2899.0 (98.5 to 99.5)99.1 (97.6 to 99.7)96.5 (94.3 to 98.0)
B Yamagata : Day 2899.3 (98.8 to 99.7)96.7 (94.5 to 98.2)99.1 (97.6 to 99.7)
SecondaryGeometric 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).

Time frame:
Day 0 (pre-vaccination) and Day 28 post-vaccination
Reported as:
Geometric mean · titers (1/dilution)
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
titers (1/dilution)High-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
A/H1N1: Day 0412 (306 to 555)427 (328 to 556)416 (311 to 555)
A/H3N2: Day 0497 (417 to 592)536 (436 to 660)593 (493 to 715)
B Victoria: Day 0458 (359 to 583)452 (367 to 556)430 (344 to 537)
B Yamagata: Day 0156 (124 to 196)155 (126 to 190)192 (152 to 242)
A/H1N1: Day 282229 (1789 to 2776)2050 (1564 to 2687)1686 (1331 to 2135)
A/H3N2: Day 281404 (1133 to 1741)1327 (1056 to 1667)1301 (1070 to 1583)
B Victoria: Day 281288 (1055 to 1573)1114 (916 to 1354)590 (476 to 730)
B Yamagata: Day 28546 (438 to 682)259 (207 to 325)494 (390 to 626)
SecondaryGMTRs 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.

Time frame:
Day 0 (pre-vaccination) and Day 28 post-vaccination
Reported as:
Number · ratio
GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
ratioHigh-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
A/H1N1: Day28/Day 05.40 (3.90 to 7.48)5.05 (3.86 to 6.60)4.06 (3.17 to 5.18)
A/H3N2: Day28/Day 02.83 (2.31 to 3.46)2.50 (2.04 to 3.06)2.19 (1.80 to 2.67)
B Victoria: Day28/Day 02.81 (2.21 to 3.58)2.47 (2.04 to 2.99)1.37 (1.16 to 1.62)
B Yamagata: Day28/Day 03.51 (2.80 to 4.39)1.66 (1.41 to 1.95)2.58 (2.18 to 3.05)
SecondaryNumber 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.

Time frame:
Day 0, Day 28
Reported as:
Count of participants · Participants
Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28
ParticipantsHigh-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
A/H1N1: >=20 (1/dil): Day 0979998
A/H1N1: >=40 (1/dil): Day 0959691
A/H1N1: >=80 (1/dil): Day 0898984
A/H3N2: >=20 (1/dil): Day 010210099
A/H3N2: >=40 (1/dil): Day 010210099
A/H3N2: >=80 (1/dil): Day 09910098
B Victoria: >=20 (1/dil): Day 010110099
B Victoria: >=40 (1/dil): Day 0979999
B Victoria: >=80 (1/dil): Day 0919693
B Yamagata: >=20 (1/dil): Day 0989899
B Yamagata: >=40 (1/dil): Day 0919387
B Yamagata: >=80 (1/dil): Day 0757574
A/H1N1: >=20 (1/dil): Day 2810210299
A/H1N1: >=40 (1/dil): Day 2810210299
A/H1N1: >=80 (1/dil): Day 2810210099
A/H3N2: >=20 (1/dil): Day 2810210299
A/H3N2: >=40 (1/dil): Day 2810210299
A/H3N2: >=80 (1/dil): Day 2810210199
B Victoria: >=20 (1/dil): Day 2810210299
B Victoria: >=40 (1/dil): Day 2810210299
B Victoria: >=80 (1/dil): Day 2810210297
B Yamagata: >=20 (1/dil): Day 2810210199
B Yamagata: >=40 (1/dil): Day 281029997
B Yamagata: >=80 (1/dil): Day 28998391
SecondaryNumber 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.

Time frame:
Day 28
Reported as:
Count of participants · Participants
Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28
ParticipantsHigh-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Participants With 2-Fold Rise: A/H1N1747164
Participants With 4-Fold Rise: A/H1N1435041
Participants With 2-Fold Rise: A/H3N2524842
Participants With 4-Fold Rise: A/H3N2272423
Participants With 2-Fold Rise: B Victoria525124
Participants With 4-Fold Rise: B Victoria28238
Participants With 2-Fold Rise: B Yamagata653155
Participants With 4-Fold Rise: B Yamagata361129
SecondaryNumber 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.

Time frame:
Day 0, Day 28
Reported as:
Count of participants · Participants
Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28
ParticipantsHigh-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
A/H1N1: Titer >= 1:10: Day 010010099
A/H1N1: Titer >= 1:10: Day 2810210299
A/H3N2: Titer >= 1:10: Day 010210099
A/H3N2: Titer >= 1:10: Day 2810210299
B Victoria: Titer >= 1:10: Day 010210099
B Victoria: Titer >= 1:10: Day 2810210299
B Yamagata: Titer >= 1:10: Day 010010099
B Yamagata: Titer >= 1:10: Day 2810210299
SecondaryNumber 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.

Time frame:
Within 7 days after vaccination
Reported as:
Count of participants · Participants
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
ParticipantsHigh-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Fever: Any Grade735
Fever: Grade 3311
Headache: Any Grade2546358
Headache: Grade 31122
Malaise: Any Grade2335267
Malaise: Grade 31331
Myalgia: Any Grade4028088
Myalgia: Grade 31633
Shivering: Any Grade952022
Shivering: Grade 3530
Injection Site Bruising: Any2364
Injection Site Bruising: Grade 3000
Injection Site Erythema: Any1103021
Injection Site Erythema: Grade 31111
Injection Site Induration: Any661714
Injection Site Induration: Grade 3301
Injection Site Pain: Any731172152
Injection Site Pain: Grade 31211
Injection Site Swelling: Any862319
Injection Site Swelling: Grade 3501
SecondaryNumber 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.

Time frame:
Within 30 minutes after vaccination
Reported as:
Count of participants · Participants
Number of Participants With Immediate Adverse Event (AEs)
ParticipantsHigh-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Number of Participants With Immediate Adverse Event (AEs)502
SecondaryNumber 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.

Time frame:
Within 28 days after vaccination
Reported as:
Count of participants · Participants
Number of Participant With Unsolicited Adverse Event (AE)
ParticipantsHigh-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Number of Participant With Unsolicited Adverse Event (AE)2927968
SecondaryNumber 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.

Time frame:
Up to 6 months after vaccination
Reported as:
Count of participants · Participants
Number of Participant With Serious Adverse Event
ParticipantsHigh-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Number of Participant With Serious Adverse Event802919

Adverse events

Collected over 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).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
High-Dose Quadrivalent Influenza Vaccine (QIV-HD)3/1,777 (0.2%)80/1,777 (4.5%)935/1,777 (52.6%)
High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)2/443 (0.5%)29/443 (6.5%)234/443 (52.8%)
High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)0/450 (0%)19/450 (4.2%)206/450 (45.8%)
Most frequent serious events
Showing 10 of 95
Most frequent serious events
EventHigh-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
OsteoarthritisMusculoskeletal and connective tissue disorders6/17774/4430/450
Coronary Artery DiseaseCardiac disorders2/17773/4430/450
PneumoniaInfections and infestations6/17772/4430/450
Facial ParalysisNervous system disorders1/17770/4432/450
SyncopeNervous system disorders3/17770/4432/450
Cardiac Failure CongestiveCardiac disorders2/17771/4431/450
Myocardial InfarctionCardiac disorders2/17771/4431/450
Stress CardiomyopathyCardiac disorders0/17771/4430/450
Diverticulum Intestinal HaemorrhagicGastrointestinal disorders0/17771/4430/450
Gastrointestinal HaemorrhageGastrointestinal disorders0/17771/4430/450
Most frequent other events
Most frequent other events
EventHigh-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Injection Site PainGeneral disorders731/1777172/443152/450
MyalgiaMusculoskeletal and connective tissue disorders404/177781/44388/450
MalaiseGeneral disorders233/177752/44367/450
HeadacheNervous system disorders258/177765/44359/450
Injection Site ErythemaGeneral disorders110/177730/44321/450
ChillsGeneral disorders96/177720/44322/450
Injection Site SwellingGeneral disorders86/177723/44319/450

Baseline characteristics

Analysis was performed on all randomized participants for whom a vaccine group was allocated.

Age, Continuous
Age, Continuous(years)High-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccine (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)Total
Mean72.9 ± 5.6372.8 ± 5.7973.2 ± 5.4973.0 ± 5.64
Sex: Female, Male
Sex: Female, Male(Participants)High-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccine (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)Total
Female10272682521547
Male7501751981123
Race (NIH/OMB)
Race (NIH/OMB)(Participants)High-Dose Quadrivalent Influenza Vaccine (QIV-HD)High-Dose Trivalent Influenza Vaccine (Licensed TIV-HD1)High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)Total
American Indian or Alaska Native92314
Asian132318
Native Hawaiian or Other Pacific Islander4116
Black or African American1234135199
White16183954022415
More than one race6129
Unknown or Not Reported4149
07

Study locations

36 sites
  • Sanofi Pasteur Investigational Site 037
    Anaheim, California 92801, United States
  • Sanofi Pasteur Investigational Site 029
    Redding, California 96001, United States
  • Sanofi Pasteur Investigational Site 003
    San Diego, California 92117, United States
  • Sanofi Pasteur Investigational Site 016
    Colorado Springs, Colorado 80920, United States
  • Sanofi Pasteur Investigational Site 035
    Milford, Connecticut 06460, United States
  • Sanofi Pasteur Investigational Site 031
    Hollywood, Florida 33024, United States
  • Sanofi Pasteur Investigational Site 009
    Jacksonville, Florida 32205, United States
  • Sanofi Pasteur Investigational Site 017
    Jacksonville, Florida 32216, United States
  • Sanofi Pasteur Investigational Site 030
    Stockbridge, Georgia 30281, United States
  • Sanofi Pasteur Investigational Site 010
    Boise, Idaho 83712, United States
  • Sanofi Pasteur Investigational Site 034
    Meridian, Idaho 83642, United States
  • Sanofi Pasteur Investigational Site 021
    Council Bluffs, Iowa 51501, United States
  • Sanofi Pasteur Investigational Site 023
    Wichita, Kansas 67205, United States
  • Sanofi Pasteur Investigational Site 028
    Wichita, Kansas 67207, United States
  • Sanofi Pasteur Investigational Site 012
    Bardstown, Kentucky 40004, United States
  • Sanofi Pasteur Investigational Site 018
    Metairie, Louisiana 70427, United States
  • Sanofi Pasteur Investigational Site 026
    Biloxi, Mississippi 39531, United States
  • Sanofi Pasteur Investigational Site 014
    Saint Louis, Missouri 63104, United States
  • Sanofi Pasteur Investigational Site 011
    Omaha, Nebraska 68134, United States
  • Sanofi Pasteur Investigational Site 024
    Las Vegas, Nevada 89104, United States
  • Sanofi Pasteur Investigational Site 008
    Rochester, New York 14609, United States
  • Sanofi Pasteur Investigational Site 005
    Wilmington, North Carolina 28401, United States
  • Sanofi Pasteur Investigational Site 036
    Winston-Salem, North Carolina 27045, United States
  • Sanofi Pasteur Investigational Site 004
    Cleveland, Ohio 44122, United States
  • Sanofi Pasteur Investigational Site 015
    Oklahoma City, Oklahoma 73112, United States
  • Sanofi Pasteur Investigational Site 013
    Warwick, Rhode Island 02886, United States
  • Sanofi Pasteur Investigational Site 033
    Mount Pleasant, South Carolina 29464, United States
  • Sanofi Pasteur Investigational Site 001
    Nashville, Tennessee 37212, United States
  • Sanofi Pasteur Investigational Site 002
    Dallas, Texas 75234, United States
  • Sanofi Pasteur Investigational Site 025
    Tomball, Texas 77375, United States
  • Sanofi Pasteur Investigational Site 027
    Salt Lake City, Utah 84109, United States
  • Sanofi Pasteur Investigational Site 006
    Salt Lake City, Utah 84121, United States
  • Sanofi Pasteur Investigational Site 019
    Salt Lake City, Utah 84123, United States
  • Sanofi Pasteur Investigational Site 020
    South Jordan, Utah 84095, United States
  • Sanofi Pasteur Investigational Site 022
    West Jordan, Utah 83642, United States
  • Sanofi Pasteur Investigational Site 038
    Norfolk, Virginia 23507, United States
08

References and documents

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 ↗

Related links

Study documents

  • Study protocol · Jul 20, 2017
  • Statistical analysis plan · Apr 18, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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

09

Registry details

Key details

Study ID
NCT03282240
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Responsible party
Sponsor
First posted
Sep 13, 2017
Start date
Sep 8, 2017
Primary completion
Nov 2, 2017
Completion
Apr 19, 2018
Results posted
Dec 17, 2019
Last update
Apr 7, 2022

Study contacts

Medical Director
study director · Sanofi Pasteur, a Sanofi Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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