AzTrials
AzTrials

InfluenzaPhase 1NCT03945825

Flublok or Fluzone With Advax-CpG55.2 or AF03

A Phase 1 study testing AF03, Delta Inulin-CpG55.2 and Influenza Virus Quadrivalent Inactivated Vaccine in people with Influenza and Influenza Immunisation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 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 is a Phase I, randomized, double blinded, clinical trial in up to 240 males and non-pregnant females, 18-45 years of age, inclusive, who are in good health and meet all eligibility criteria. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Influenza, Influenza Immunisation
What is being tested?
AF03, Delta Inulin-CpG55.2 and Influenza Virus Quadrivalent Inactivated Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
241 participants
Where
8 sitesUnited States
Study dates
10 Jun 2019to 18 Sep 2020
Phase
Phase 1
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 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Provide written informed consent prior to initiation of any study procedures.
  • Are able to understand and comply with planned study procedures and be available for all study visits.
  • Must agree to the collection of venous blood per protocol.
  • Are males or non-pregnant females, 18 to 45 years of age, inclusive at time of enrollment.
  • Are in good health*. *As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical or psychiatric diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, emergency room or urgent care for condition, or invasive medical procedure and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose or in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening or treatment of continued symptoms of medical diagnosis or condition. Note: Low dose topical, corticosteroids as outlined in the Subject Exclusion Criteria as well as herbals, vitamins and supplements are permitted.
  • Oral temperature is less than 100.0 degrees Fahrenheit.
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  • Pulse is 47 to 100 beats per minute, inclusive.
  • Systolic blood pressure is 85 to 140 mmHg, inclusive.
  • Diastolic blood pressure is 55 to 90 mmHg, inclusive.
  • Screening laboratories (Erythrocyte Sedimentation Rate (ESR), White Blood Cells (WBC), Hemoglobin (Hgb), Platelets (PLTs), Alanine Aminotransferase (ALT), Total Bilirubin (T. Bili), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Alkaline Phosphatase (ALP) serum lipase, serum amylase and Creatinine (Cr)) are within acceptable parameters*.
  • ESR must be below 30 mm/hr; WBC >3.90 K/MM3 and <10.60 K/MM3; Hgb >/= 11.5 g/dl (women) or >/= 12.5 g/dl (men); PLTs (EDTA) 140-415 K/MM3; PLTs (Citrate) 125-325 K/MM3 ALT </= 43 U/L (women) or </= 60 U/L (men); T Bili </=1.20 mg/dl; Cr < 1.1 mg/dl (women) or < 1.4 mg/dl (men); AST 10-36 U/L (women) or 10-43 U/L (men); GGT 5--32 U/L (women) or 10-49 U/L (men); ALP 30-115 U/L (women) or 43-115 U/L (men); lipase 13-60 U/L; amylase (Total) 35-121 U/L, for subjects to qualify for randomization and vaccination.
  • Women of childbearing potential* must use an acceptable contraception method** from at least 30 days before the first study vaccination until 60 days after the second study vaccination.
  • Not sterilized via bilateral oophorectomy, tubal ligation/ salpingectomy, hysterectomy, or successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year has passed since the last menses if menopausal.
  • Includes non-male sexual relationships, full abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more and shown to be azoospermic prior to the subject receiving the study vaccination, barrier methods such as condoms or diaphragms/cervical cap with spermicide, effective intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill").
  • Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to the first study vaccination.
  • For a woman with potential to become pregnant, she understands that in the event of pregnancy during the study she will be approached to enroll in the Sanofi Pregnancy Registry.
  • Must agree to have residual specimens (i.e. residual/excess of per protocol specifications).

Who cannot join

  • Have an acute illness*, as determined by the site Principal Investigator (PI) or appropriate sub-investigator, within 72 hours prior to study vaccination.
  • An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
  • Have any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation*.
  • Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.
  • Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy.
  • Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
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  • Have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted.
  • Have known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.
  • Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccine.
  • Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines.
  • Have a history of Guillain-Barré Syndrome (GBS).
  • Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination.
  • Have a history of Potentially Immune-Mediated Medical Conditions (PIMMCs).
  • Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
  • Have any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere* with subject compliance or safety evaluations.
  • As determined by the site PI or appropriate sub-investigator.
  • Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination.
  • Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination.
  • Have taken high-dose inhaled corticosteroids* within 30 days prior to study vaccination.
  • High-dose defined as per age as using inhaled high-dose per reference chart in the National Heart, Lung and Blood Institute Guidelines for the Diagnosis and Management of Asthma (EPR-3) or other lists published in UPTODATE.
  • Received or plan to receive a licensed, live vaccine (excluding all licensed, seasonal LAIVs) within 30 days before or after the study vaccination.
  • Received or plan to receive a licensed, inactivated vaccine (excluding all licensed, seasonal IIVs) within 14 days before or after each study vaccination.
  • Have received any 2018/2019 seasonal influenza vaccine within the 6 months prior to enrollment.
  • Plans to receive any 2019/2020 seasonal influenza vaccine within approximately 90 days of receipt of the first study vaccination.
  • Have a known history of documented influenza infection within the past 6 months.
  • Received immunoglobulin or other blood products (except Rho D immunoglobulin) within 90 days prior to study vaccination.
  • Received an experimental agent* within 30 days prior to the study vaccination or expect to receive another experimental agent* during the trial-reporting period*.
  • Including vaccine, drug, biologic, device, blood product, or medication.
  • Other than from participation in this trial.
  • Approximately 12 months after the first study vaccination.
  • Are participating or plan to participate in another clinical trial with an interventional agent* that will be received during the trial-reporting period**.
  • Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication.
  • Approximately 12 months after the first study vaccination.
  • Female subjects who are breastfeeding or plan to breastfeed from the time of the first study vaccination through 30 days after the last study vaccination.
  • Plan to travel outside the US (continental US, Hawaii and Alaska) from the time of study vaccination through approximately 90 days after the first study vaccination.
  • Planning to donate blood within 4 months following first vaccination.
  • All study participants will be expected to receive the second study vaccination except under the circumstances listed below. The second study vaccination will not be administered to a subject if any of the following criteria are met:
  • Meets the contraindication on the package insert to receipt of licensed influenza vaccine.
  • As deemed necessary by the site principal investigator or appropriate sub-investigator for noncompliance or other reasons.
  • Subject refusal of further study vaccination.
  • Withdrawal of consent.
  • Subject is lost to follow-up.
  • Termination of this trial.
  • New information becomes available that makes further participation unsafe.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Emory University School of Medicine

    Atlanta, Georgia, 30322-1014

  • University of Maryland Baltimore - School of Medicine - Medicine

    Baltimore, Maryland, 21201-1509

  • Cincinnati Children's Hospital Medical Center Vaccine Research Center

    Cincinnati, Ohio, 45229-3039

  • Duke Vaccine and Trials Unit

    Durham, North Carolina, 27704

  • Baylor College of Medicine

    Houston, Texas, 77030-3411

  • University of Iowa - Vaccine Research and Education Unit

    Iowa City, Iowa, 52242-2600

  • Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center

    Nashville, Tennessee, 37232-2573

  • Saint Louis University Center for Vaccine Development

    St Louis, Missouri, 63104-1015

Other trials in United States

About this study

Official title: A Phase I Study to Assess the Safety, Reactogenicity and Immunogenicity of Two Quadrivalent Seasonal Influenza Vaccines (Fluzone(R) or Flublok(R)) With or Without One of Two Adjuvants (AF03 or Advax-CpG55.2) in Healthy Adults 18-45 Years of Age

This is a Phase I, randomized, double blinded, clinical trial in up to 240 males and non-pregnant females, 18-45 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of either the 2018/2019 seasonal Fluzone or Flublok Quadrivalent Influenza Vaccine (QIV) manufactured by Sanofi Pasteur (SP) given without adjuvant or with one of two adjuvant formulations, AF03 or Advax-CpG55.2. Eight Vaccine and Treatment Evaluation Unit (VTEU) sites will be included in the study. Study duration is approximately 18 months, and subject participation duration is 12 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 2) to assess the serum hemagglutination inhibition (HAI) antibody responses against 2018/2019 QIV strains from baseline (Day 1) to approximately Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 3) to assess the serum neuraminidase inhibition antibody (NAI) responses by enzyme-linked lectin assay (ELLA) against NA antigens in the 2018/2019 QIV from baseline (Day 1) to approximately Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 4) to assess the influenza neutralizing (Neut) antibody titer responses against 2018/2019 QIV strains from baseline (Day 1) to approximately Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax- CpG55.2 adjuvant.

Read the detailed description

This is a Phase I, randomized, double blinded, clinical trial in up to 240 males and non-pregnant females, 18-45 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of either the 2018/2019 seasonal Fluzone or Flublok Quadrivalent Influenza Vaccine (QIV) manufactured by Sanofi Pasteur (SP) given without adjuvant or with one of two adjuvant formulations, AF03 or Advax-CpG55.2. Subjects will be stratified by prior receipt of licensed, seasonal influenza vaccine (defined as receipt of at least one of the 2017/2018 and/or 2018/2019 influenza vaccines) and will be randomly assigned to 1 of 6 treatment arms to receive a single dose of one of the two seasonal 2018/2019 QIV vaccine formulations with or without one of the two adjuvants (Day 1). On approximately Day 90, each subject will receive a single dose of the seasonal 2019/2020 QIV. Groups 1, 2 and 3 will receive 2019/2020 Fluzone QIV and Groups 4, 5 and 6 will receive 2019/2020 Flublok QIV. Eight Vaccine and Treatment Evaluation Unit (VTEU) sites will be included in the study. Study duration is approximately 18 months, and subject participation duration is 12 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 2) to assess the serum hemagglutination inhibition (HAI) antibody responses against 2018/2019 QIV strains from baseline (Day 1) to approximately Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 3) to assess the serum neuraminidase inhibition antibody (NAI) responses by enzyme-linked lectin assay (ELLA) against NA antigens in the 2018/2019 QIV from baseline (Day 1) to approximately Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 4) to assess the influenza neutralizing (Neut) antibody titer responses against 2018/2019 QIV strains from baseline (Day 1) to approximately Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax- CpG55.2 adjuvant. The secondary objectives of this study are: 1) to assess protocol specified adverse events of special interest (AESI), medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs) that occur after receipt of study product; 2) to assess the HAI, Neut and NAI ELLA responses to the 2019/2020 QIV strains prior to (Day 1) and approximately 28 days after vaccination with the 2019/2020 QIV in all study groups; 3) to assess the HAI antibody responses against heterologous influenza A/H1 and H3 strains from baseline (Day 1) to approximately Days 8, 29, 57, 90 and 118 after receipt of 2018/2019 Fluzone or Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 4) to assess NAI ELLA responses against heterologous N1 and N2 NA antigens from baseline (Day 1) to approximately Days 8, 29, 57, 90 and 118 after administration of 2018/2019 Fluzone with and without AF03 or Advax-CpG55.2 adjuvant; 5) to assess the influenza neutralizing (Neut) antibody titer responses against heterologous influenza A/H1 and H3 strains from baseline (Day 1) to approximately Days 8, 29, 57, 90 and 118 after administration of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 6) to assess the longitudinal kinetics and durability of the HAI, NAI, and Neut responses against the 2018/2019 QIV strains on approximately Days 8, 57, 90 and 118 following receipt of the 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant.

Being tested
AF03, Delta Inulin-CpG55.2, Influenza Virus Quadrivalent Inactivated Vaccine, Quadrivalent Recombinant Seasonal Influenza Vaccine
Keywords
Immunogenicity, Influenza, Influenza Vaccine, Phase 1, Quadrivalent, Safety
Medical subject headings
Influenza, Human

What participants receive

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

  • AF03Drug

    A squalene-in-PBS emulsion stabilized by nonionic surfactants, sorbitan oleate and macrogol cetostearyl ether

  • Delta Inulin-CpG55.2Biological

    A combination adjuvant supplied as two separate components, Delta Inulin (Sypharma Pty Ltd.) and CpG55.2 (Nikko Denka Avecia and Sypharma Pty Ltd)

  • Influenza Virus Quadrivalent Inactivated VaccineBiological

    2018/2019 Fluzone QIV and 2019/2020 Fluzone QIV vaccines will be given with 90 days interval

  • Quadrivalent Recombinant Seasonal Influenza VaccineBiological

    2018/2019 Flublok QIV and 2019/2020 Flublok QIV vaccines will be given with 90 days interval

Study groups in NCT03945825
Study groupRoleWhat they receive
Group 1Experimental0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90, n=40
Receives: Biological: Influenza Virus Quadrivalent Inactivated Vaccine
Group 2Experimental0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90, n=40
Receives: Drug: AF03; Biological: Influenza Virus Quadrivalent Inactivated Vaccine
Group 3Experimental0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90, n=40
Receives: Biological: Delta Inulin-CpG55.2; Biological: Influenza Virus Quadrivalent Inactivated Vaccine
Group 4Experimental0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90, n=40
Receives: Biological: Quadrivalent Recombinant Seasonal Influenza Vaccine
Group 5Experimental0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90, n=40
Receives: Drug: AF03; Biological: Quadrivalent Recombinant Seasonal Influenza Vaccine
Group 6Experimental0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90, n=40
Receives: Biological: Delta Inulin-CpG55.2; Biological: Quadrivalent Recombinant Seasonal Influenza Vaccine

What is being measured

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

  1. Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination

    Local adverse events (AEs) solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value >0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value >0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value >0mm).

    Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the local or systemic AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.

    Measured: Day 1 through Day 8

  2. Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29

    Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through 28 days after the first study vaccination while serious adverse events (SAEs) were collected at follow up visits through approximately 12 months after the first study vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).

    Measured: Day 1 through Day 29

  3. Number of Participants Reporting Serious Adverse Events (SAEs)

    SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All SAEs were reported from time of first study vaccination through approximately 12 months after the first study vaccination.

    Measured: Day 1 through Day 365

  4. Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination

    Laboratory parameters include white blood cells (WBC), hemoglobin, platelets, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, Gamma-Glutamyl Transferase (GGT), alkaline phosphatase (ALP), amylase, lipase, and creatinine. Thresholds for adverse events were considered WBC of 3.90 x10^3/uL or lower or 10.60 x10^3/uL or higher; hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10^3/uL or below or 416 x10^3/uL or greater when using EDTA tubes or platelets 124 x10^3/uL or below or 550 x10^3/uL or greater when using Citrate tubes; ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); AST 37 IU/L or greater (female) or 44 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; GGT 33 IU/L or greater (female) or 50 IU/L or greater (male); ALP 116 IU/L or greater; amylase 122 IU/L or greater; lipase 61 IU/L or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male).

    Measured: Day 1 through Day 8

  5. Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination.

    Measured: Day 1, Day 29

  6. Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated.

    Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs.

    Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Measured: Day 1, Day 29

  7. Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. HAI seroconversion was defined as either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

    Measured: Day 29

  8. Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result.

    Measured: Day 1, Day 29

  9. Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 29 titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Measured: Day 29

  10. Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination.

    Measured: Day 1, Day 29

  11. Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

    Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated.

    Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs.

    Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Measured: Day 1, Day 29

  12. Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. NAI seroconversion was defined as >4 four-fold rise in post-vaccination antibody titer at Day 29.

    Measured: Day 29

  13. Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 29 titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Measured: Day 29

  14. Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination.

    Measured: Day 1, Day 29

  15. Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated.

    Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs.

    Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Measured: Day 1, Day 29

  16. Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Neut seroconversion was defined as either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

    Measured: Day 29

  17. Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab.

    Measured: Day 1, Day 29

  18. Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Fold-rises from baseline were calculated as the Day 29 titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Measured: Day 29

Secondary outcomes (42)

  1. Number of Participants Reporting Protocol Specified Adverse Events of Special Interest (AESIs)

    Participants were queried at each visit for the occurrence of adverse events of special interest (AESIs) through approximately 12 months following the first study vaccination. AESIs include reports of tearing, dry mouth, and dry eyes.

    Measured: Day 1 through Day 365

  2. Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)

    Participants were queried at each visit for the occurrence of medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs) through approximately 12 months following the first study vaccination.

    Measured: Day 1 through Day 365

  3. Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination.

    Measured: Day 90 through Day 118

  4. Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

    Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated.

    Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs.

    Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Measured: Day 90 through Day 118

  5. Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. HAI seroconversion was defined as either a pre-second vaccination titer < 1:10 and a post- second vaccination titer >= 1:40 or a pre-second vaccination titer >= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

    Measured: Day 118

  6. Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result.

    Measured: Day 90 through Day 118

  7. Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises at Day 118 were calculated as the Day 118 titer divided by the Day 90 titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Measured: Day 90 through Day 118

  8. Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination.

    Measured: Day 90 through Day 118

  9. Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated.

    The unadjuvanted Fluzone study arm is considered a reference group for the analysis of ratio of GMTs.

    Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Measured: Day 90 through Day 118

  10. Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. NAI seroconversion was defined as >4 four-fold rise in post-vaccination antibody titer at Day 90 through Day 118.

    Measured: Day 118

  11. Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises at Day 118 were calculated as the Day 118 titer divided by the Day 90 titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Measured: Day 118

  12. Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination.

    Measured: Day 90 through Day 118

  13. Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

    Blood was collected for Neut assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated.

    Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs.

    Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Measured: Day 90 through Day 118

  14. Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Neut seroconversion was defined as either a pre-second vaccination titer < 1:10 and a post-second vaccination titer >= 1:40 or a pre-second vaccination titer >= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

    Measured: Day 118

  15. Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Fold-rises at Day 118 were calculated as the Day 118 titer divided by the Day 90 titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Measured: Day 118

  16. Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination.

    Measured: Day 8, Day 57, Day 90, Day 118

  17. Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated.

    Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs.

    Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Measured: Day 8, Day 57, Day 90, Day 118

  18. Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. HAI seroconversion was defined as either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

    Measured: Day 8, Day 57, Day 90, Day 118

  19. Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result.

    Measured: Day 8, Day 57, Day 90, Day 118

  20. Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 8 (or Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Measured: Day 8, Day 57, Day 90, Day 118

  21. Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination.

    Measured: Day 8, Day 57, Day 90, Day 118

  22. Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated.

    The unadjuvanted Fluzone study arm is considered a reference group for the analysis of ratio of GMTs.

    Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Measured: Day 8, Day 57, Day 90, Day 118

  23. Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. NAI seroconversion was defined as >4 four-fold rise in post-vaccination antibody titer at Day 8, 57, 90, and 118.

    Measured: Day 8, Day 57, Day 90, Day 118

  24. Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 8 (or Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Measured: Day 8, Day 57, Day 90, Day 118

  25. Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which is a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination.

    Measured: Day 8, Day 57, Day 90, Day 118

  26. Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which is a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated.

    Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs.

    Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Measured: Day 8, Day 57, Day 90, Day 118

  27. Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which is a geometric mean titer of the replicates was reported by the lab. Neut seroconversion was defined as either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

    Measured: Day 8, Day 57, Day 90, Day 118

  28. Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which is a geometric mean titer of the replicates was reported by the lab.

    Measured: Day 8, Day 57, Day 90, Day 118

  29. Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Fold-rises from baseline were calculated as the Day 8 (or Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Measured: Day 8, Day 57, Day 90, Day 118

  30. Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains

    Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 post first study vaccination.

    Measured: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118

  31. Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms

    Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms was calculated.

    Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs.

    Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Measured: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118

  32. Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains

    Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. HAI seroconversion was defined as either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

    Measured: Day 8, Day 29, Day 57, Day 90, Day 118

  33. Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains

    Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result.

    Measured: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118

  34. Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains

    Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 8 (or Day 29, Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Measured: Day 8, Day 29, Day 57, Day 90, Day 118

  35. Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the heterologous N1 and N2 NA viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 Post first study vaccination.

    Measured: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118

  36. Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the heterologous N1 and N2 NA viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated.

    The unadjuvanted Fluzone study arm is considered a reference group for the analysis of ratio of GMTs.

    Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Measured: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118

  37. Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the heterologous N1 and N2 NA viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. NAI seroconversion was defined as >4 four-fold rise in post-vaccination antibody titer at Day 8, 29, 57, 90, and 118.

    Measured: Day 8, Day 29, Day 57, Day 90, Day 118

  38. Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the heterologous N1 and N2 NA viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 8 (or Day 29, Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Measured: Day 8, Day 29, Day 57, Day 90, Day 118

  39. Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains

    Blood was collected for Neut assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 Post first study vaccination.

    Measured: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118

  40. Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms

    Blood was collected for Neut assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated.

    Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs.

    Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Measured: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118

  41. Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains

    Blood was collected for Neut assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Neut seroconversion was defined as either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

    Measured: Day 8, Day 29, Day 57, Day 90, Day 118

  42. Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains

    Blood was collected for Neut assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Fold-rises from baseline were calculated as the Day 8 (or Day 29, Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Measured: Day 8, Day 29, Day 57, Day 90, Day 118

Timeline

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

  1. First posted10 May 2019
  2. Study start10 Jun 2019
  3. Primary completion18 Sep 2020
  4. Study completion18 Sep 2020

Resources

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03945825
Sponsor's protocol ID
18-0011
Other IDs
HHSN272201300018I
Status last verified
19 Feb 2021
First submitted
9 May 2019
Last updated
14 Oct 2025
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hegmann TE, Walter EB, Smith MJ, Campbell J, El Sahly HM, Whitaker JA, Creech CB, Ustyugova IV, Goncalvez AP, Pandey A, Alefantis T, Sridhar S, Honda-Okubo Y, Petrovsky N, Frey SE, Abate G, Paulsen G, Anderson EJ, Rostad CA, Rouphael N, Makhene M, Roberts PC, Tuyishimire B, Bryant C, Winokur P. A phase I study of the safety, reactogenicity and immunogenicity of two quadrivalent seasonal influenza vaccines (Fluzone(R) or Flublok(R)) with or without one of two adjuvants (AF03 or Advax-CpG55.2) in healthy adults 18-45 years of age. Vaccine. 2025 Apr 30;54:126991. doi: 10.1016/j.vaccine.2025.126991. Epub 2025 Mar 18.

    PubMed 40107003

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AF03, Delta Inulin-CpG55.2 and Influenza Virus Quadrivalent Inactivated Vaccine in people with Influenza and Influenza Immunisation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 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 17 inclusion and 44 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 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 3 Jan 2022). 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 Local and Systemic Solicited Reactogenicity Events Post First Vaccination (time frame: Day 1 through Day 8). The study lists 18 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 NCT03945825, 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 14 Oct 2025.

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