Influenza, Influenza Immunisation
Conditions
Keywords
Immunogenicity, Influenza, Influenza Vaccine, Phase 1, Quadrivalent, Safety
Brief 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. 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.
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.
Interventions
DRUGAF03
A squalene-in-PBS emulsion stabilized by nonionic surfactants, sorbitan oleate and macrogol cetostearyl ether
BIOLOGICALDelta Inulin-CpG55.2
A combination adjuvant supplied as two separate components, Delta Inulin (Sypharma Pty Ltd.) and CpG55.2 (Nikko Denka Avecia and Sypharma Pty Ltd)
2018/2019 Fluzone QIV and 2019/2020 Fluzone QIV vaccines will be given with 90 days interval
2018/2019 Flublok QIV and 2019/2020 Flublok QIV vaccines will be given with 90 days interval
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provide written informed consent prior to initiation of any study procedures. 2. Are able to understand and comply with planned study procedures and be available for all study visits. 3. Must agree to the collection of venous blood per protocol. 4. Are males or non-pregnant females, 18 to 45 years of age, inclusive at time of enrollment. 5. 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. 6. Oral temperature is less than 100.0 degrees Fahrenheit. 7. Pulse is 47 to 100 beats per minute, inclusive. 8. Systolic blood pressure is 85 to 140 mmHg, inclusive. 9. Diastolic blood pressure is 55 to 90 mmHg, inclusive. 10. 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. 11. 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). 12. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to the first study vaccination. 13. 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. 14. Must agree to have residual specimens (i.e. residual/excess of per protocol specifications).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination | Day 1 through Day 8 | 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. |
| Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29 | Day 1 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). |
| Number of Participants Reporting Serious Adverse Events (SAEs) | Day 1 through Day 365 | 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. |
| Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Day 1 through Day 8 | 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). |
| Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 1, Day 29 | 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. |
| 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 | Day 1, Day 29 | 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. |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 29 | 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. |
| Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 1, Day 29 | 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. |
| Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 29 | 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. |
| Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 1, Day 29 | 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. |
| 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 | Day 1, Day 29 | 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. |
| Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 29 | 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. |
| Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 29 | 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. |
| Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 1, Day 29 | 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. |
| Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | Day 1, Day 29 | 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. |
| Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 29 | 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. |
| Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 1, Day 29 | 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. |
| Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 29 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 8, Day 57, Day 90, Day 118 | 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. |
| Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 8, Day 57, Day 90, Day 118 | 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. |
| Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | Day 8, Day 57, Day 90, Day 118 | 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. |
| 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 | Day 8, Day 57, Day 90, Day 118 | 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. |
| Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | Day 8, Day 57, Day 90, Day 118 | 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. |
| Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | Day 8, Day 57, Day 90, Day 118 | 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. |
| Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 8, Day 57, Day 90, Day 118 | 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. |
| Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | Day 8, Day 57, Day 90, Day 118 | 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. |
| Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 8, Day 57, Day 90, Day 118 | 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. |
| Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 8, Day 57, Day 90, Day 118 | 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. |
| Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 8, Day 57, Day 90, Day 118 | 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. |
| Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | Day 1, Day 8, Day 29, Day 57, Day 90, Day 118 | 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. |
| Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | Day 1, Day 8, Day 29, Day 57, Day 90, Day 118 | 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. |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | Day 8, Day 29, Day 57, Day 90, Day 118 | 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. |
| Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | Day 1, Day 8, Day 29, Day 57, Day 90, Day 118 | 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. |
| Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | Day 8, Day 29, Day 57, Day 90, Day 118 | 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. |
| Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | Day 1, Day 8, Day 29, Day 57, Day 90, Day 118 | 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. |
| 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 | Day 1, Day 8, Day 29, Day 57, Day 90, Day 118 | 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. |
| Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | Day 8, Day 29, Day 57, Day 90, Day 118 | 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. |
| Number of Participants Reporting Protocol Specified Adverse Events of Special Interest (AESIs) | Day 1 through Day 365 | 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. |
| Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | Day 1, Day 8, Day 29, Day 57, Day 90, Day 118 | 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. |
| Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | Day 1, Day 8, Day 29, Day 57, Day 90, Day 118 | 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. |
| Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | Day 8, Day 29, Day 57, Day 90, Day 118 | 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. |
| Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | Day 8, Day 29, Day 57, Day 90, Day 118 | 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. |
| Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | Day 8, Day 29, Day 57, Day 90, Day 118 | 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. |
| Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | Day 1 through Day 365 | 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. |
| Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | Day 90 through Day 118 | 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. |
| 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 | Day 90 through Day 118 | 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. |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | Day 118 | 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. |
| Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | Day 90 through Day 118 | 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. |
| Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | Day 90 through Day 118 | 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. |
| Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | Day 90 through Day 118 | 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. |
| 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 | Day 90 through Day 118 | 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. |
| Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | Day 118 | 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. |
| Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | Day 118 | 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. |
| Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | Day 90 through Day 118 | 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. |
| Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | Day 90 through Day 118 | 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. |
| Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | Day 118 | 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. |
| Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | Day 118 | 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. |
| Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 8, Day 57, Day 90, Day 118 | 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. |
| 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 | Day 8, Day 57, Day 90, Day 118 | 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. |
| Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | Day 8, Day 57, Day 90, Day 118 | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were healthy males and non-pregnant females aged 18 to 45 years old recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 18JUN2019 and 27AUG2019.
Participants by arm
| Arm | Count |
|---|---|
| Fluzone 0.5 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. | 41 |
| Fluzone + AF03 0.5 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. | 37 |
| Fluzone + CpG55 0.5 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 mL of 2019/2020 of Fluzone QIV intramuscular injection on Day 90. | 40 |
| Flublok 0.5 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. | 41 |
| Flublok + AF03 0.5 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. | 39 |
| Flublok + CpG55 0.5 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. | 43 |
| Total | 241 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Enrolled but treatment not administered | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 5 | 0 | 1 | 2 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Fluzone | Fluzone + AF03 | Fluzone + CpG55 | Flublok | Flublok + AF03 | Flublok + CpG55 | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 37 Participants | 40 Participants | 41 Participants | 39 Participants | 43 Participants | 241 Participants |
| Age, Continuous | 30.7 years STANDARD_DEVIATION 7.2 | 29.6 years STANDARD_DEVIATION 6.2 | 28.2 years STANDARD_DEVIATION 7 | 30.2 years STANDARD_DEVIATION 7.6 | 29.7 years STANDARD_DEVIATION 6.8 | 28.7 years STANDARD_DEVIATION 6.5 | 29.5 years STANDARD_DEVIATION 6.9 |
| BMI | 26.73 kg/m^2 STANDARD_DEVIATION 5.37 | 26.87 kg/m^2 STANDARD_DEVIATION 6.29 | 24.82 kg/m^2 STANDARD_DEVIATION 4.64 | 26.91 kg/m^2 STANDARD_DEVIATION 6.55 | 26.25 kg/m^2 STANDARD_DEVIATION 6.81 | 25.79 kg/m^2 STANDARD_DEVIATION 5.67 | 26.22 kg/m^2 STANDARD_DEVIATION 5.91 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 3 Participants | 7 Participants | 5 Participants | 3 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 33 Participants | 36 Participants | 34 Participants | 34 Participants | 40 Participants | 217 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Prior Seasonal Influenza Vaccination Either 2017-2018 or 2018-2019 | 36 Participants | 29 Participants | 32 Participants | 32 Participants | 30 Participants | 36 Participants | 195 Participants |
| Prior Seasonal Influenza Vaccination Neither 2017-2018 or 2018-2019 | 5 Participants | 7 Participants | 8 Participants | 8 Participants | 9 Participants | 7 Participants | 44 Participants |
| Prior Seasonal Influenza Vaccination Unknown | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 4 Participants | 5 Participants | 5 Participants | 5 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 4 Participants | 2 Participants | 7 Participants | 8 Participants | 2 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 33 Participants | 28 Participants | 32 Participants | 26 Participants | 24 Participants | 34 Participants | 177 Participants |
| Region of Enrollment United States | 41 participants | 37 participants | 40 participants | 41 participants | 39 participants | 43 participants | 241 participants |
| Sex: Female, Male Female | 22 Participants | 26 Participants | 28 Participants | 27 Participants | 23 Participants | 26 Participants | 152 Participants |
| Sex: Female, Male Male | 19 Participants | 11 Participants | 12 Participants | 14 Participants | 16 Participants | 17 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 37 | 0 / 40 | 0 / 42 | 0 / 37 | 0 / 43 |
| other Total, other adverse events | 37 / 41 | 36 / 37 | 40 / 40 | 36 / 42 | 34 / 37 | 43 / 43 |
| serious Total, serious adverse events | 0 / 41 | 1 / 37 | 0 / 40 | 0 / 42 | 0 / 37 | 1 / 43 |
Outcome results
Primary
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.
Time frame: Day 29
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 2.4 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 3.0 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 2.0 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 2.6 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 2.3 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 3.2 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 2.6 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 2.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 2.3 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 2.2 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 2.9 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 3.6 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 3.8 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 2.6 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 2.1 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 2.1 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 3.7 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 4.0 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 3.7 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 3.8 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 2.9 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 2.1 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 3.2 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 4.3 fold rise |
Primary
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.
Time frame: Day 29
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 2.1 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) | 2.3 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 2.1 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage | 1.8 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 2.5 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) | 2.6 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 2.5 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage | 2.1 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage | 1.6 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 2.4 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) | 2.2 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 2.6 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 1.0 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage | 1.2 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) | 1.2 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 1.0 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 1.0 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage | 1.2 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) | 1.1 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 1.0 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) | 1.2 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 1.1 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage | 1.2 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 1.0 fold rise |
Primary
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.
Time frame: Day 29
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 3.6 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 2.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 1.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 2.4 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 1.9 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 2.8 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 4.3 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 2.4 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 1.9 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 2.2 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 2.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 4.6 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 5.5 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 2.4 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 2.3 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 2.1 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 4.2 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 3.4 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 3.5 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 5.9 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 2.8 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 2.1 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 2.3 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 4.6 fold rise |
Primary
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.
Time frame: Day 1, Day 29
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 242.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 140.9 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 114.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 366.3 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 270.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 423.0 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 488.3 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 952.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 478.7 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 1356.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 193.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 474.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 456.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 196.6 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 149.8 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 538.2 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 120.2 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 174.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 489.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 1081.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 340.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 349.7 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 365.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 96.8 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 680.0 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 515.4 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 634.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 164.1 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 296.6 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 618.7 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 1645.6 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 248.3 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 1280.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 129.7 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 516.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 416.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 722.9 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 107.1 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 186.8 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 331.9 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 1280.0 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 492.5 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 237.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 390.1 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 388.7 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 131.3 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 522.5 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 108.6 titer |
Primary
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.
Time frame: Day 1, Day 29
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 118.0 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) - Day 1 | 178.6 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 123.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 63.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 259.0 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) - Day 29 | 402.0 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 250.4 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 116.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 89.5 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 188.5 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 116.4 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 264.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) - Day 29 | 538.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 108.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) - Day 1 | 211.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 293.4 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) - Day 1 | 213.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 96.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 91.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 143.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 224.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) - Day 29 | 464.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 216.4 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 91.9 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 161.4 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) - Day 29 | 346.0 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 157.3 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 140.9 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 143.3 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 88.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 112.2 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) - Day 1 | 256.9 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 92.1 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 129.7 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 129.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) - Day 29 | 243.9 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 129.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) - Day 1 | 226.3 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 127.4 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 81.5 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 82.1 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 107.5 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 100.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 66.7 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) - Day 29 | 211.5 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) - Day 1 | 166.7 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 105.7 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 105.9 titer |
Primary
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.
Time frame: Day 1, Day 29
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 3141.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 108.9 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 106.8 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 479.4 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 379.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 302.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 5639.5 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 1162.7 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 577.8 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 1437.4 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 147.7 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 5435.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 305.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 2697.5 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 113.4 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 671.9 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 94.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 2147.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 630.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 1152.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 456.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 248.4 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 4455.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 101.9 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 8539.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 463.3 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 848.9 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 151.6 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 3703.3 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 860.1 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 2053.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 199.4 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 1473.1 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 121.2 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 741.9 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 304.8 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 9197.6 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 81.9 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 2214.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 447.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 1291.7 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 567.0 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 2764.2 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 539.2 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 291.6 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 101.0 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 6021.9 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 118.5 titer |
Primary
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).
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all participants who received the first study vaccination. Analyses for the safety population are based on vaccine actually received. One participant randomized to Flublok + AF03 group received Flublok due to a pharmacy error and is analyzed in the Flublok group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluzone | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | GGT | 2 Participants |
| Fluzone | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | AST | 0 Participants |
| Fluzone | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Creatinine | 1 Participants |
| Fluzone | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Amylase | 1 Participants |
| Fluzone | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Bilirubin | 0 Participants |
| Fluzone | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Hemoglobin | 1 Participants |
| Fluzone | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | WBCs | 6 Participants |
| Fluzone | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Platelets | 0 Participants |
| Fluzone | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | ALT | 1 Participants |
| Fluzone | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | ALP | 0 Participants |
| Fluzone | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Lipase | 0 Participants |
| Fluzone + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Lipase | 1 Participants |
| Fluzone + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | GGT | 0 Participants |
| Fluzone + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | ALT | 1 Participants |
| Fluzone + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | AST | 1 Participants |
| Fluzone + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Platelets | 0 Participants |
| Fluzone + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Creatinine | 0 Participants |
| Fluzone + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Amylase | 0 Participants |
| Fluzone + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | ALP | 0 Participants |
| Fluzone + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | WBCs | 2 Participants |
| Fluzone + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Bilirubin | 0 Participants |
| Fluzone + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Hemoglobin | 1 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Bilirubin | 1 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | ALP | 0 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | GGT | 0 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Hemoglobin | 2 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | WBCs | 3 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Platelets | 0 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Lipase | 1 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | ALT | 0 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Creatinine | 0 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Amylase | 1 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | AST | 0 Participants |
| Flublok | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Lipase | 0 Participants |
| Flublok | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | WBCs | 2 Participants |
| Flublok | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Hemoglobin | 3 Participants |
| Flublok | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Platelets | 4 Participants |
| Flublok | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | ALT | 1 Participants |
| Flublok | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | AST | 1 Participants |
| Flublok | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Bilirubin | 0 Participants |
| Flublok | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | GGT | 0 Participants |
| Flublok | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | ALP | 0 Participants |
| Flublok | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Amylase | 0 Participants |
| Flublok | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Creatinine | 0 Participants |
| Flublok + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | ALP | 1 Participants |
| Flublok + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Platelets | 0 Participants |
| Flublok + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Creatinine | 0 Participants |
| Flublok + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Lipase | 0 Participants |
| Flublok + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Amylase | 0 Participants |
| Flublok + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Hemoglobin | 0 Participants |
| Flublok + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | AST | 2 Participants |
| Flublok + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | WBCs | 3 Participants |
| Flublok + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | ALT | 1 Participants |
| Flublok + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | GGT | 0 Participants |
| Flublok + AF03 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Bilirubin | 1 Participants |
| Flublok + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Bilirubin | 0 Participants |
| Flublok + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Creatinine | 1 Participants |
| Flublok + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | ALP | 1 Participants |
| Flublok + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | AST | 1 Participants |
| Flublok + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | ALT | 1 Participants |
| Flublok + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Amylase | 0 Participants |
| Flublok + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Platelets | 0 Participants |
| Flublok + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Hemoglobin | 0 Participants |
| Flublok + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | Lipase | 0 Participants |
| Flublok + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | WBCs | 0 Participants |
| Flublok + CpG55 | Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination | GGT | 2 Participants |
Primary
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.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all participants who received the first study vaccination. Analyses for the safety population are based on vaccine actually received. One participant randomized to Flublok + AF03 group received Flublok due to a pharmacy error and is analyzed in the Flublok group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluzone | Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination | Any Systemic Symptom | 24 Participants |
| Fluzone | Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination | Any Local Symptom | 35 Participants |
| Fluzone + AF03 | Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination | Any Systemic Symptom | 25 Participants |
| Fluzone + AF03 | Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination | Any Local Symptom | 36 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination | Any Systemic Symptom | 23 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination | Any Local Symptom | 40 Participants |
| Flublok | Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination | Any Systemic Symptom | 23 Participants |
| Flublok | Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination | Any Local Symptom | 32 Participants |
| Flublok + AF03 | Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination | Any Systemic Symptom | 18 Participants |
| Flublok + AF03 | Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination | Any Local Symptom | 33 Participants |
| Flublok + CpG55 | Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination | Any Systemic Symptom | 26 Participants |
| Flublok + CpG55 | Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination | Any Local Symptom | 43 Participants |
Primary
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.
Time frame: Day 1 through Day 365
Population: The Safety Analysis population includes all participants who received the first study vaccination. Analyses for the safety population are based on vaccine actually received. One participant randomized to Flublok + AF03 group received Flublok due to a pharmacy error and is analyzed in the Flublok group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluzone | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Fluzone + AF03 | Number of Participants Reporting Serious Adverse Events (SAEs) | 1 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Flublok | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Flublok + AF03 | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Flublok + CpG55 | Number of Participants Reporting Serious Adverse Events (SAEs) | 1 Participants |
Primary
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).
Time frame: Day 1 through Day 29
Population: The Safety Analysis population includes all participants who received the first study vaccination. Analyses for the safety population are based on vaccine actually received. One participant randomized to Flublok + AF03 group received Flublok due to a pharmacy error and is analyzed in the Flublok group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluzone | Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29 | AEs | 12 Participants |
| Fluzone | Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29 | SAEs | 0 Participants |
| Fluzone + AF03 | Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29 | AEs | 11 Participants |
| Fluzone + AF03 | Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29 | SAEs | 0 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29 | AEs | 8 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29 | SAEs | 0 Participants |
| Flublok | Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29 | AEs | 14 Participants |
| Flublok | Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29 | SAEs | 0 Participants |
| Flublok + AF03 | Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29 | AEs | 10 Participants |
| Flublok + AF03 | Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29 | SAEs | 0 Participants |
| Flublok + CpG55 | Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29 | AEs | 15 Participants |
| Flublok + CpG55 | Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29 | SAEs | 0 Participants |
Primary
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.
Time frame: Day 29
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 27 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 29 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 24 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 24 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 19 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 36 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 33 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 25 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 23 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 18 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 31 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 36 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 45 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 28 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 23 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 23 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 46 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 30 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 41 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 46 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 32 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 32 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 34 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 56 percentage of participants |
Primary
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.
Time frame: Day 29
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 27 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) | 27 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 27 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 20 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) | 25 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 36 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 31 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 22 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 36 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 10 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 36 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) | 18 percentage of participants |
| Flublok | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 3 percentage of participants |
| Flublok | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 3 percentage of participants |
| Flublok | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 3 percentage of participants |
| Flublok | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) | 0 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 0 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) | 0 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 0 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 0 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 2 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 2 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 2 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Colorado/06/2017 (B Victoria lineage) | 5 percentage of participants |
Primary
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.
Time frame: Day 29
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 37 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 22 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 15 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 24 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 11 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 19 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 42 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 14 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 18 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 21 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 28 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 38 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 60 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 18 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 20 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 20 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 41 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 30 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 30 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 65 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 34 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) | 20 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 22 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) | 56 percentage of participants |
Primary
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.
Time frame: Day 1, Day 29
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 93 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 98 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 85 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 80 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 95 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 95 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 95 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 89 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 88 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 80 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 97 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 97 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 75 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 98 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 90 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 93 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 95 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 93 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 92 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 89 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 79 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 76 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 88 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 90 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 95 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 100 percentage of participants |
Primary
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.
Time frame: Day 1, Day 29
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 78 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 88 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 95 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 97 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 95 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 97 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 97 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 78 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 68 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 98 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 95 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 75 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 100 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 90 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 100 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 90 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 100 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 95 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 100 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 83 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 89 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 92 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 71 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 92 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 98 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 95 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 76 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 90 percentage of participants |
Primary
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.
Time frame: Day 1, Day 29
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 1.0 ratio of GMT |
| Fluzone | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 2.0 ratio of GMT |
| Fluzone | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 1.1 ratio of GMT |
| Fluzone | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 1.1 ratio of GMT |
| Fluzone | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 1.7 ratio of GMT |
| Fluzone | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 1.4 ratio of GMT |
| Fluzone | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 0.8 ratio of GMT |
| Fluzone | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 1.3 ratio of GMT |
| Fluzone + AF03 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 0.7 ratio of GMT |
| Fluzone + AF03 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 0.7 ratio of GMT |
| Fluzone + AF03 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 1.3 ratio of GMT |
| Fluzone + AF03 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 1.1 ratio of GMT |
| Fluzone + AF03 | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 1.3 ratio of GMT |
| Fluzone + AF03 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 0.9 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 0.8 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 0.8 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 0.4 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 0.6 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 0.5 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 0.8 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 0.8 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 1.1 ratio of GMT |
| Flublok | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 0.8 ratio of GMT |
| Flublok | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 0.6 ratio of GMT |
| Flublok | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 0.8 ratio of GMT |
| Flublok | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 0.8 ratio of GMT |
| Flublok | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 0.8 ratio of GMT |
| Flublok | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 0.5 ratio of GMT |
| Flublok | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 0.8 ratio of GMT |
| Flublok | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 0.7 ratio of GMT |
Primary
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.
Time frame: Day 1, Day 29
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 0.9 ratio of GMT |
| Fluzone | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 1 | 1.2 ratio of GMT |
| Fluzone | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 0.9 ratio of GMT |
| Fluzone | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 1.4 ratio of GMT |
| Fluzone | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 1.1 ratio of GMT |
| Fluzone | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 29 | 1.3 ratio of GMT |
| Fluzone | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 1.1 ratio of GMT |
| Fluzone | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 1.6 ratio of GMT |
| Fluzone + AF03 | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 29 | 1.2 ratio of GMT |
| Fluzone + AF03 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 0.9 ratio of GMT |
| Fluzone + AF03 | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 1 | 1.2 ratio of GMT |
| Fluzone + AF03 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 1.2 ratio of GMT |
| Fluzone + AF03 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 0.9 ratio of GMT |
| Fluzone + AF03 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 1.4 ratio of GMT |
| Fluzone + AF03 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 0.7 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 0.8 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 0.9 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 0.9 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 0.8 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 29 | 0.7 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 0.8 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 0.9 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 1 | 0.9 ratio of GMT |
| Flublok | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 0.7 ratio of GMT |
| Flublok | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 0.8 ratio of GMT |
| Flublok | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 1 | 0.6 ratio of GMT |
| Flublok | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 0.8 ratio of GMT |
| Flublok | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 0.7 ratio of GMT |
| Flublok | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 0.7 ratio of GMT |
| Flublok | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 0.7 ratio of GMT |
| Flublok | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 29 | 0.6 ratio of GMT |
Primary
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.
Time frame: Day 1, Day 29
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 1.4 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 1.0 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 0.9 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 1.2 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 1.8 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 1.0 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 1.0 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 1.2 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 0.8 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 1.2 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 0.9 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 1.0 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 0.8 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 1.3 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 0.7 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 1.0 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 1.1 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 0.6 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 0.5 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 0.9 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 0.7 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 0.7 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 0.8 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 0.4 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 1 | 0.7 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 1 | 0.6 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1 | 0.5 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1 | 0.8 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29 | 0.7 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 29 | 0.6 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 29 | 0.7 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29 | 0.6 ratio of GMT |
Secondary
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.
Time frame: Day 8, Day 29, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 3.5 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 2.6 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 1.9 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 1.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 2.4 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 1.9 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 9.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 2.9 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 1.4 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 4.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 3.1 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 5.1 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 2.4 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 4.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 1.7 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 4.1 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 3.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 3.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 1.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 1.5 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 2.0 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 2.4 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 2.0 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 3.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 2.9 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 2.5 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 4.0 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 1.9 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 2.4 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 2.8 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 2.8 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 4.1 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 1.4 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 3.1 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 4.8 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 1.3 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 2.4 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 1.6 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 3.5 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 2.1 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 1.6 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 3.2 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 3.8 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 2.7 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 3.4 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 4.2 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 3.9 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 3.9 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 3.1 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 1.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 2.9 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 1.5 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 6.5 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 4.2 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 4.1 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 2.6 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 3.1 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 2.0 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 4.9 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 4.2 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 4.9 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 3.8 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 1.3 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 3.6 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 4.6 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 2.3 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 3.3 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 3.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 2.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 1.2 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 2.4 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 3.4 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 9.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 1.5 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 5.2 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 3.1 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 3.0 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 3.0 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 3.0 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 2.8 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 1.3 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 4.6 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 3.8 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 6.1 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 5.0 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 1.7 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 3.6 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 3.6 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 4.2 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 3.9 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 1.5 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 2.9 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 5.1 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 3.8 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 1.6 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 6.8 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 8.1 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 7.8 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 15.5 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 2.9 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 5.1 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 3.9 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 5.2 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 5.7 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 5.8 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 11.0 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 16.5 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 1.7 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 4.5 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 1.4 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 1.8 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 10.4 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 9.5 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 4.9 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 7.1 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 4.5 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 5.3 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 1.4 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 3.9 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 3.5 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 3.9 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 4.0 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 8.1 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 5.8 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 2.8 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 3.6 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 3.2 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 4.0 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 4.2 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 5.7 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 1.6 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 11.1 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 3.5 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 5.1 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 8.1 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 1.5 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 4.4 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 4.8 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 6.6 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 5.5 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 1.4 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 6.9 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 3.4 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 3.9 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 2.4 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 7.5 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 4.7 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 1.4 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 3.6 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 5.0 fold rise |
Secondary
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.
Time frame: Day 8, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 3.1 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 2.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 2.0 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 3.1 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 2.6 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 2.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 2.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 2.3 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 2.5 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 2.4 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 2.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 2.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1.9 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1.7 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 2.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1.8 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 2.8 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 2.9 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 2.1 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 2.4 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 2.2 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 3.0 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1.9 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 2.2 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 2.2 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 3.5 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 2.7 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1.8 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 2.7 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 3.0 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 2.2 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 2.3 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.8 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 5.0 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 3.3 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 2.2 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 2.1 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 2.3 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 2.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 2.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 2.3 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 2.5 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1.8 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1.8 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1.5 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 3.5 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 3.0 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 2.8 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 6.1 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 2.3 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 1.9 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 3.4 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 3.6 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 2.7 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 2.5 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1.8 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 2.4 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 2.8 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 1.6 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1.7 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 2.4 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 1.7 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 2.0 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 1.7 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 6.7 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 3.3 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 3.8 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 3.6 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 2.9 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 2.8 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 2.9 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 3.1 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 3.8 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 2.6 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 3.8 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 3.8 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 3.8 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 4.2 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 3.1 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 2.5 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 2.6 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 2.3 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 2.5 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 2.6 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 2.1 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 2.6 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 2.8 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 2.4 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 3.0 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 5.3 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 3.6 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 2.2 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 3.3 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 2.1 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 2.3 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 3.2 fold rise |
Secondary
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.
Time frame: Day 8, Day 29, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 29 | 1.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 118 | 1.4 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 90 | 1.3 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 29 | 1.5 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 8 | 2.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 90 | 1.4 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 57 | 1.6 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 118 | 2.4 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 90 | 1.4 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 57 | 1.5 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 118 | 1.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 57 | 1.3 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 57 | 1.3 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 8 | 1.5 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 57 | 1.6 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 57 | 1.6 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 8 | 1.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 118 | 2.1 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 29 | 1.3 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 8 | 2.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 90 | 1.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 29 | 1.7 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 118 | 2.0 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 8 | 2.1 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 29 | 1.3 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 8 | 2.1 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 90 | 1.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 29 | 1.7 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 118 | 1.5 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 90 | 1.5 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 90 | 2.0 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 8 | 2.5 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 8 | 2.5 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 8 | 1.8 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 8 | 2.9 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 8 | 2.6 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 8 | 2.1 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 29 | 1.7 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 29 | 2.0 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 29 | 1.6 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 29 | 2.1 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 29 | 2.2 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 29 | 1.9 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 57 | 1.8 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 57 | 1.6 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 57 | 1.4 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 57 | 1.8 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 57 | 2.0 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 57 | 1.6 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 90 | 1.6 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 90 | 1.4 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 90 | 1.4 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 90 | 1.5 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 90 | 1.3 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 118 | 2.0 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 118 | 1.7 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 118 | 1.6 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 118 | 2.0 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 118 | 2.0 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 118 | 1.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 29 | 2.3 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 8 | 1.8 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 90 | 1.3 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 29 | 1.8 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 8 | 2.4 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 90 | 1.4 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 29 | 1.5 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 29 | 1.8 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 90 | 2.2 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 29 | 1.6 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 118 | 2.2 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 90 | 1.3 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 8 | 1.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 8 | 2.3 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 118 | 2.1 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 8 | 2.9 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 118 | 1.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 57 | 1.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 57 | 1.4 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 118 | 2.0 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 57 | 2.0 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 57 | 1.5 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 8 | 2.4 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 57 | 1.5 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 57 | 1.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 118 | 2.4 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 90 | 1.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 29 | 1.6 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 118 | 1.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 90 | 1.3 fold rise |
Secondary
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.
Time frame: Day 8, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 8 | 2.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 2.0 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 1.6 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 2.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 3.6 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 57 | 1.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 90 | 1.6 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 118 | 2.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 3.4 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 1.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 1.6 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 2.4 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 2.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.6 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1.9 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 57 | 2.0 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 90 | 1.9 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 118 | 2.5 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 2.0 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 3.9 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 2.0 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1.7 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 1.6 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 4.3 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.7 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 2.2 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 2.0 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 1.7 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 2.1 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 8 | 2.7 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 2.3 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 1.4 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 57 | 1.5 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1.9 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 1.8 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 90 | 1.5 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 4.3 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 118 | 2.0 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 2.2 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 8 | 1.9 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 3.6 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 2.4 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 1.8 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 2.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.5 fold rise |
Secondary
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.
Time frame: Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) | 1.2 Fold Rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) | 1.3 Fold Rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) | 1.3 Fold Rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Kansas/14/2017 (H3N2) | 1.4 Fold Rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Kansas/14/2017 (H3N2) | 1.1 Fold Rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) | 1.0 Fold Rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) | 1.2 Fold Rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) | 1.3 Fold Rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Kansas/14/2017 (H3N2) | 1.3 Fold Rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) | 1.3 Fold Rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) | 1.2 Fold Rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) | 1.1 Fold Rise |
Secondary
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.
Time frame: Day 8, Day 29, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 1.6 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 4.6 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 1.7 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 1.9 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 1.3 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 1.9 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 1.4 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 2.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 1.3 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 1.5 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 1.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 1.4 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 0.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 1.0 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 1.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 2.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 1.3 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 1.4 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 1.3 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 3.0 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 1.5 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 4.3 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 2.5 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 2.9 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 2.1 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 1.6 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 1.9 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 1.0 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 2.8 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 2.2 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 2.5 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 3.4 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 1.5 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 2.3 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 2.3 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 1.8 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 1.8 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 1.7 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 1.2 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 1.9 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 1.6 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 1.3 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 1.8 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 5.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 4.3 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 3.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 1.4 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 1.2 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 1.9 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 1.6 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 4.8 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 2.3 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 1.6 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 1.3 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 1.8 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 1.5 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 2.4 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 3.0 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 1.6 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 0.9 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 1.9 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 3.2 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 2.6 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 6.8 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 3.3 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 1.9 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 1.9 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 2.9 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 3.6 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 1.9 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 3.1 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 4.2 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 1.7 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 4.7 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 6.9 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 3.2 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 2.7 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 1.7 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 2.0 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 1.4 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 3.0 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 2.4 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 1.3 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 5.5 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 2.6 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 4.1 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 1.5 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 3.0 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 3.8 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 2.9 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 1.4 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 3.8 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 3.5 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 1.9 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 1.1 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 9.9 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 7.3 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 4.2 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 2.3 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 4.6 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 1.7 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 1.4 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 3.5 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 3.1 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 3.8 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 1.8 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 2.3 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 2.3 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 2.6 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 3.4 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 3.2 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 1.7 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 3.5 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 2.1 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 4.6 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 2.0 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 5.9 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 6.1 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 7.8 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 1.4 fold rise |
Secondary
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.
Time frame: Day 8, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 2.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 1.4 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 1.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 1.7 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 1.3 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 3.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 2.3 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 1.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 2.2 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 1.0 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 1.5 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 1.5 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 2.3 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1.8 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.4 fold rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 2.2 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 1.7 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 2.9 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 1.7 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 2.1 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 1.6 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 1.8 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 2.1 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1.8 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 1.7 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 2.9 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 2.1 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1.7 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 1.7 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 1.6 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.5 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 3.2 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.2 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 2.4 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 2.8 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 2.5 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 2.0 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 1.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 2.6 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 1.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 1.6 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 1.8 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1.9 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1.7 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1.6 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 1.5 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 2.0 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 1.6 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 3.0 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 1.8 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 1.9 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 1.8 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 2.3 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 2.0 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.6 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 2.2 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 1.6 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 2.1 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 1.5 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1.8 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 1.1 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 2.2 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 2.3 fold rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 1.8 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 3.5 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 2.1 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 3.0 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 1.7 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 2.8 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 3.6 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 2.5 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 2.1 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 2.9 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 2.4 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 3.0 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 3.8 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 2.5 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 3.0 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 2.6 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 2.7 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 2.2 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 2.1 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.4 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 2.5 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 2.1 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 2.0 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 2.6 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 1.7 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 2.3 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 2.4 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 2.1 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1.5 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 1.7 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 2.9 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 2.3 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 1.3 fold rise |
Secondary
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.
Time frame: Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 1.0 Fold Rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 5.1 Fold Rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 1.7 Fold Rise |
| Fluzone | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 0.8 Fold Rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 1.2 Fold Rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 2.5 Fold Rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 1.0 Fold Rise |
| Fluzone + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 0.9 Fold Rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 0.9 Fold Rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 1.5 Fold Rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 3.9 Fold Rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 1.3 Fold Rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 1.4 Fold Rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 0.9 Fold Rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 4.5 Fold Rise |
| Flublok | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 1.5 Fold Rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 1.3 Fold Rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 0.9 Fold Rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 3.9 Fold Rise |
| Flublok + AF03 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 1.1 Fold Rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 3.1 Fold Rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 1.7 Fold Rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 0.9 Fold Rise |
| Flublok + CpG55 | Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 1.3 Fold Rise |
Secondary
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.
Time frame: Day 90 through Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 1.1 fold rise |
| Fluzone | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 7.1 fold rise |
| Fluzone | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 0.8 fold rise |
| Fluzone | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 1.1 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 0.8 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 3.3 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 1.1 fold rise |
| Fluzone + AF03 | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 0.9 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 6.9 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 1.0 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 1.0 fold rise |
| Fluzone + CpG55 | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 1.2 fold rise |
| Flublok | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 1.3 fold rise |
| Flublok | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 1.0 fold rise |
| Flublok | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 5.4 fold rise |
| Flublok | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 0.8 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 0.9 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 1.0 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 5.5 fold rise |
| Flublok + AF03 | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 1.3 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 3.6 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 1.1 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 1.4 fold rise |
| Flublok + CpG55 | Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 1.1 fold rise |
Secondary
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.
Time frame: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 140.9 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 215.6 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 113.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 1 | 82.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 103.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 269.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 124.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 1 | 72.9 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 74.6 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 146.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 189.5 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 174.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 72.3 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 178.6 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 99.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 115.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 184.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 202.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 1 | 29.8 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 116.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 182.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 1 | 63.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 59.5 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 320.0 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 184.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 112.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 265.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 256.4 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 129.5 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 95.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 271.7 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 435.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 508.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 137.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 248.5 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 417.4 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 1 | 61.5 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 272.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 131.4 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 264.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 351.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 183.8 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 152.5 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 1 | 141.7 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 169.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 452.5 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 440.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 415.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 1 | 98.3 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 338.5 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 113.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 299.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 278.6 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 496.4 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 163.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 1 | 123.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 483.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 415.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 169.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 646.2 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 94.7 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 282.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 157.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 121.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 129.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 155.7 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 75.7 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 121.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 438.9 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 79.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 77.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 70.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 167.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 216.2 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 1 | 67.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 1 | 29.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 301.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 259.9 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 1 | 62.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 96.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 86.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 222.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 296.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 226.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 1 | 76.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 311.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 188.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 251.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 291.9 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 253.1 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 176.4 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 87.8 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 261.2 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 400.9 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 314.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 272.7 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 583.9 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 1 | 112.2 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 314.6 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 433.4 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 407.9 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 331.6 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 877.8 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 1 | 105.7 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 312.0 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 656.9 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 452.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 545.4 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 784.7 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 1 | 43.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 130.6 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 226.3 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 177.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 673.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 1 | 98.0 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 129.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 168.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 154.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 162.9 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 323.3 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 812.2 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 709.5 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 153.2 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 196.6 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 405.6 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 78.5 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 132.7 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 1 | 69.8 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 416.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 129.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 323.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 521.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 423.8 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 456.8 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 357.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 1 | 58.1 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 394.7 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 1 | 80.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 100.5 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 580.6 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 78.6 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 108.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 288.7 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 317.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 81.5 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 661.1 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 440.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 1 | 33.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 516.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 148.7 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 460.5 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 650.9 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 1 | 87.6 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 106.6 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 63.5 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 180.1 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 374.3 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 366.3 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 1 | 78.0 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 106.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 388.4 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 127.4 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 543.7 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 578.0 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 244.6 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 402.0 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 117.9 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 124.5 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 293.4 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 405.5 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 366.3 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 111.2 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 121.1 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 365.3 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 299.6 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 281.9 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 339.0 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 1 | 34.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 180.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 1 | 74.9 titer |
Secondary
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.
Time frame: Day 8, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 441.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 248.9 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 224.4 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 320.0 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 296.6 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 322.8 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 312.0 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 323.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 603.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 629.0 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 526.9 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 586.9 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 714.3 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 629.0 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 797.3 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 665.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 570.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 561.3 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 281.8 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 339.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 456.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 582.8 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 905.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1061.3 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 519.8 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 525.7 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 520.8 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 874.3 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 548.6 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 582.8 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1129.4 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 338.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 849.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 404.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 400.9 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 254.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 245.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 255.7 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 472.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 440.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 366.9 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 361.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 792.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 889.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 740.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 343.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 266.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 245.6 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 962.2 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 673.3 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 480.1 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 565.1 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 602.3 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 868.9 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1502.0 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1133.8 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 757.7 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 897.3 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 404.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1045.0 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 398.7 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 422.2 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1228.9 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 410.4 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 839.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 444.1 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 402.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 469.4 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 323.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 311.1 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 320.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1041.6 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 689.8 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 905.1 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 697.9 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 701.1 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 506.4 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 771.9 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1019.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 839.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 329.9 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 542.6 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 995.6 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 344.7 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 817.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 645.4 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1065.4 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 571.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 715.9 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 554.9 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 408.9 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 875.7 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 383.9 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 286.7 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 303.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 347.5 titer |
Secondary
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.
Time frame: Day 90 through Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 797.3 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 325.5 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 665.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 323.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 312.0 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 90 | 33.8 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 118 | 203.5 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 387.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 281.8 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 339.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 118 | 213.6 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 874.3 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 367.6 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 326.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 90 | 67.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1129.4 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 245.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 255.7 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 269.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 90 | 38.2 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 234.7 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 118 | 274.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 849.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 792.8 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 90 | 69.4 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 410.4 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1228.9 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1502.0 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 627.1 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 404.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 118 | 369.1 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 456.6 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 118 | 254.9 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 90 | 50.1 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 323.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1041.6 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 509.8 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 320.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 905.1 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 408.2 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 995.6 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 355.1 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 491.0 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 90 | 62.2 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 118 | 212.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1065.4 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 303.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 329.9 titer |
Secondary
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.
Time frame: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 1 | 108.5 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 90 | 144.6 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 1 | 33.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 8 | 197.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 1 | 16.6 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 118 | 72.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 29 | 143.3 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 118 | 32.4 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 90 | 57.5 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 57 | 144.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 29 | 21.9 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 57 | 63.3 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 90 | 139.8 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 8 | 181.6 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 29 | 65.9 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 118 | 141.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 1 | 48.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 8 | 80.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 1 | 37.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 8 | 34.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 1 | 124.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 8 | 104.0 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 57 | 153.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 118 | 69.9 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 29 | 80.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 57 | 26.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 90 | 60.0 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 57 | 76.6 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 118 | 167.9 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 57 | 51.9 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 90 | 69.3 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 29 | 181.6 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 29 | 59.5 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 118 | 83.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 90 | 22.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 8 | 72.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 8 | 317.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 1 | 20.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 8 | 49.6 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 29 | 35.6 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 57 | 37.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 90 | 34.6 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 118 | 39.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 1 | 47.3 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 8 | 117.5 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 29 | 95.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 57 | 76.3 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 90 | 66.6 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 118 | 81.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 1 | 105.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 8 | 191.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 29 | 161.5 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 57 | 151.3 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 90 | 145.3 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 118 | 160.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 1 | 35.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 8 | 100.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 29 | 74.8 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 57 | 62.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 90 | 53.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 118 | 70.5 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 1 | 45.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 8 | 117.5 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 29 | 102.8 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 57 | 90.4 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 90 | 96.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 118 | 91.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 1 | 154.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 29 | 305.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 57 | 250.8 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 90 | 215.6 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 118 | 266.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 1 | 92.7 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 90 | 157.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 1 | 28.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 118 | 62.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 29 | 201.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 8 | 81.4 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 90 | 48.9 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 29 | 23.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 29 | 62.9 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 57 | 53.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 1 | 14.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 57 | 56.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 29 | 68.2 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 57 | 183.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 90 | 63.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 8 | 91.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 8 | 35.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 118 | 68.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 1 | 40.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 118 | 212.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 1 | 31.7 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 118 | 130.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 1 | 126.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 8 | 75.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 90 | 113.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 118 | 29.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 29 | 54.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 57 | 117.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 90 | 24.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 57 | 48.4 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 29 | 128.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 8 | 216.7 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 90 | 40.4 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 8 | 167.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 57 | 24.2 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 118 | 54.9 titer |
Secondary
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.
Time frame: Day 8, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 8 | 385.4 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 262.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 201.0 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 258.9 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 441.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 57 | 309.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 90 | 286.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 118 | 373.3 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 398.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 218.6 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 189.5 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 261.4 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 137.4 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 117.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 104.0 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 115.3 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 57 | 427.8 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 90 | 391.7 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 118 | 474.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 177.4 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 419.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 220.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 158.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 176.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 501.7 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 156.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 260.4 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 218.6 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 201.6 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 242.5 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 8 | 566.6 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 208.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 125.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 57 | 311.4 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 174.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 148.7 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 90 | 294.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 150.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 394.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 118 | 400.4 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 177.2 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 8 | 415.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 352.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 157.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 202.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 155.7 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 200.2 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 137.0 titer |
Secondary
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.
Time frame: Day 90 through Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 90.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 107.8 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Kansas/14/2017 (H3N2) - Day 90 | 35.8 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Kansas/14/2017 (H3N2) - Day 118 | 48.5 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 104.0 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 115.3 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 90 | 286.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 118 | 373.3 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Kansas/14/2017 (H3N2) - Day 90 | 49.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 90 | 391.7 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Kansas/14/2017 (H3N2) - Day 118 | 51.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 156.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 158.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 91.5 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 111.8 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 118 | 474.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Kansas/14/2017 (H3N2) - Day 90 | 36.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 79.2 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 72.4 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Kansas/14/2017 (H3N2) - Day 118 | 45.7 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 90 | 294.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 150.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 137.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 118 | 400.4 titer |
Secondary
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.
Time frame: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 344.4 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 1382.3 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 43.3 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 53.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 300.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 62.4 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 819.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 396.0 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 1 | 858.5 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 1232.8 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 1237.6 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 556.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 94.6 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 830.8 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 1128.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 45.4 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 151.6 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 293.5 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 267.6 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 237.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 1 | 34.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 841.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 1071.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 1 | 183.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 1000.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 2083.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 1 | 46.7 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 1723.8 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 111.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 1785.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 2284.7 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 70.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 486.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 139.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 1268.8 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 400.6 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 315.4 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 698.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 1798.5 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 117.6 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 101.3 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 1501.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 1602.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 1541.8 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 1 | 294.8 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 1 | 852.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 469.4 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 535.4 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 421.4 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 720.2 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 946.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 61.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 283.7 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 1 | 218.7 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 1487.2 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 1 | 616.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 1656.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 200.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 65.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 150.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 312.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 1631.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 348.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 1088.9 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 778.8 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 64.7 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 1416.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 1 | 40.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 48.9 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 369.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 946.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 1032.4 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 1086.0 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 2739.4 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 326.1 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 1 | 736.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 936.6 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 2572.0 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 412.1 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 1212.0 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 88.2 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 431.4 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 1051.7 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 1940.2 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 82.0 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 1 | 47.1 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 821.9 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 1424.0 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 151.8 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 634.0 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 1533.4 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 1 | 226.8 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 1331.6 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 149.1 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 431.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 1297.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 1020.1 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 1 | 40.3 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 983.9 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 296.5 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 1563.9 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 1 | 232.4 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 107.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 2359.5 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 852.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 3672.3 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 147.2 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 559.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 121.5 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 388.6 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 1795.8 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 733.5 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 444.3 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 1537.3 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 688.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 156.5 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 1208.6 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 1 | 667.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 904.9 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 965.5 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 1641.9 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 307.9 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 1 | 40.9 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 1 | 217.9 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 1 | 624.2 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 1425.2 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 86.9 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 505.9 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 882.3 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 1922.4 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 81.4 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 790.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 1054.4 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 1032.9 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 140.0 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 517.7 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 1158.3 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 1268.5 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 129.6 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 385.5 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 905.2 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 2233.2 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 241.3 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 733.9 titer |
Secondary
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.
Time frame: Day 8, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 309.6 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 150.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 132.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 161.8 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 140.6 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 365.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 255.4 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 202.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 6824.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 3437.4 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 4623.9 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 5094.4 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1126.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 859.6 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 681.0 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1087.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 257.6 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 7795.4 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 180.7 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 235.4 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 244.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 271.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1225.3 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1049.1 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 5393.5 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 333.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 312.9 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1031.7 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 4965.3 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 4437.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 909.3 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 358.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 766.9 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 224.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 261.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 232.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 178.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 151.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 5604.4 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 3335.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 3255.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 3153.9 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1086.9 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1095.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1037.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 154.0 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 195.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 152.8 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 446.6 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 6666.4 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 369.0 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 273.4 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 354.4 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 8037.0 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1371.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1959.7 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 6518.8 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 8293.9 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 312.0 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1515.8 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 168.8 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 439.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1920.9 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 362.6 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 409.5 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 265.7 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 243.2 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 210.6 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 234.1 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 300.2 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 212.1 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 953.5 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 6113.7 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1234.9 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 6631.4 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 8444.6 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 309.0 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 6502.7 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1154.5 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1243.1 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 211.7 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 5925.2 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 754.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 255.4 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1173.0 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 5791.6 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1284.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 4837.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 6168.6 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 276.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 259.3 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 824.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 202.7 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 306.0 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 232.4 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 148.5 titer |
Secondary
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.
Time frame: Day 90 through Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 90 | 50.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 3891.7 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 3375.3 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 118 | 238.1 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 681.0 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1087.2 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 255.4 titer |
| Fluzone | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 202.2 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 118 | 198.0 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 180.7 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 3727.3 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 235.4 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1031.7 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 90 | 81.4 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 3613.3 titer |
| Fluzone + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 909.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 2895.1 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 90 | 57.2 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 118 | 225.6 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 151.5 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 766.9 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1086.9 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 178.3 titer |
| Fluzone + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 2488.0 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 362.6 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1920.9 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1371.5 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 4850.2 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 90 | 90.7 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 118 | 396.6 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 312.0 titer |
| Flublok | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 6618.8 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 212.1 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 5622.8 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 953.5 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1234.9 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 234.1 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 5654.7 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 90 | 72.3 titer |
| Flublok + AF03 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 118 | 266.5 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 211.7 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 754.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 90 | 79.1 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 118 | 251.9 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1284.8 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 4983.6 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 232.4 titer |
| Flublok + CpG55 | Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 3899.5 titer |
Secondary
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.
Time frame: Day 1 through Day 365
Population: The Safety Analysis population includes all participants who received the first study vaccination. Analyses for the safety population are based on vaccine actually received. One participant randomized to Flublok + AF03 group received Flublok due to a pharmacy error and is analyzed in the Flublok group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluzone | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMCs | 1 Participants |
| Fluzone | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAEs | 9 Participants |
| Fluzone | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMCs | 0 Participants |
| Fluzone + AF03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMCs | 0 Participants |
| Fluzone + AF03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAEs | 13 Participants |
| Fluzone + AF03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMCs | 0 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMCs | 0 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAEs | 7 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMCs | 0 Participants |
| Flublok | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMCs | 0 Participants |
| Flublok | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAEs | 8 Participants |
| Flublok | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMCs | 1 Participants |
| Flublok + AF03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAEs | 7 Participants |
| Flublok + AF03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMCs | 1 Participants |
| Flublok + AF03 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMCs | 0 Participants |
| Flublok + CpG55 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | NOCMCs | 0 Participants |
| Flublok + CpG55 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | MAAEs | 10 Participants |
| Flublok + CpG55 | Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs) | PIMMCs | 0 Participants |
Secondary
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.
Time frame: Day 1 through Day 365
Population: The Safety Analysis population includes all participants who received study vaccination. Analyses for the safety population are based on vaccine actually received. One participant randomized to Flublok + AF03 group received Flublok due to a pharmacy error and is analyzed in the Flublok group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluzone | Number of Participants Reporting Protocol Specified Adverse Events of Special Interest (AESIs) | 0 Participants |
| Fluzone + AF03 | Number of Participants Reporting Protocol Specified Adverse Events of Special Interest (AESIs) | 0 Participants |
| Fluzone + CpG55 | Number of Participants Reporting Protocol Specified Adverse Events of Special Interest (AESIs) | 0 Participants |
| Flublok | Number of Participants Reporting Protocol Specified Adverse Events of Special Interest (AESIs) | 0 Participants |
| Flublok + AF03 | Number of Participants Reporting Protocol Specified Adverse Events of Special Interest (AESIs) | 0 Participants |
| Flublok + CpG55 | Number of Participants Reporting Protocol Specified Adverse Events of Special Interest (AESIs) | 0 Participants |
Secondary
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.
Time frame: Day 8, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 23 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 22 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 42 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 22 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 17 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 15 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 20 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 27 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 22 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 22 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 22 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 20 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 24 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 25 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 27 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 20 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 22 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 37 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 35 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 22 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 19 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 24 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 35 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 30 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 25 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 17 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 17 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 10 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 16 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 19 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 14 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 13 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 13 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 24 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 32 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 35 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 16 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 30 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 26 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 23 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 16 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 50 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 24 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 24 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 32 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 24 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 20 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 15 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 33 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 15 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 29 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 26 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 43 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 41 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 22 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 15 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 15 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 24 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 28 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 32 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 71 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 12 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 15 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 18 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 38 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 72 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 27 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 39 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 47 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 54 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 29 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 16 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 47 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 46 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 30 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 35 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 31 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 47 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 35 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 41 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 26 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 23 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 30 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 35 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 24 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 22 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 56 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 44 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 24 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 44 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 23 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 22 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 43 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 21 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 43 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 29 percentage of participants |
Secondary
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.
Time frame: Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 0 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 67 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 0 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 0 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 0 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 43 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 0 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 0 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 0 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 0 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 74 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 0 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 6 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 0 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 56 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 0 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 0 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 0 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 53 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 0 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 53 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 0 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 0 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 6 percentage of participants |
Secondary
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.
Time frame: Day 8, Day 29, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 11 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 39 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 23 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 58 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 27 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 56 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 41 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 10 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 44 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 34 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 3 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 27 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 20 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 37 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 5 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 53 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 32 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 23 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 78 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 27 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 20 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 2 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 25 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 51 percentage of participants |
| Fluzone | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 18 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 56 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 35 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 53 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 19 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 38 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 33 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 8 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 6 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 30 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 19 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 13 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 38 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 37 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 41 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 24 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 8 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 11 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 47 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 31 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 22 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 30 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 27 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 31 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 36 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 30 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 30 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 39 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 47 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 24 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 5 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 35 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 45 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 10 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 82 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 36 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 31 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 51 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 56 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 62 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 8 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 26 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 33 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 29 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 39 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 32 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 15 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 62 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 5 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 24 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 24 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 50 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 40 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 79 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 48 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 55 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 46 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 45 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 29 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 59 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 5 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 85 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 71 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 8 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 29 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 32 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 8 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 38 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 40 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 10 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 38 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 27 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 53 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 74 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 65 percentage of participants |
| Flublok | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 38 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 11 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 16 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 50 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 47 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 58 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 47 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 57 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 57 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 78 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 73 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 49 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 57 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 62 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 46 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 11 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 38 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 41 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 62 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 43 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 14 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 69 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 75 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 88 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 91 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 38 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 79 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 45 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 10 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 44 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 66 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 48 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 76 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 51 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 46 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 59 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 78 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 12 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 82 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 63 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 7 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 59 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 40 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 26 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 91 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 57 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 13 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 48 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 65 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 45 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 40 percentage of participants |
Secondary
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.
Time frame: Day 8, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 8 | 20 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 20 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 12 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 28 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 49 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 57 | 18 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 90 | 10 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 118 | 19 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 46 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 15 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 10 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 25 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 27 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 18 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 12 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 17 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 57 | 16 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 90 | 8 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 118 | 20 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 16 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 57 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 22 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 10 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 11 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 62 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 11 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 22 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 13 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 8 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 23 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 8 | 30 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 30 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 3 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 57 | 8 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 20 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 13 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 90 | 5 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 6 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 50 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 118 | 9 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 24 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) - Day 8 | 13 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 50 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 8 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 24 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 11 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 32 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 5 percentage of participants |
Secondary
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.
Time frame: Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) | 6 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Kansas/14/2017 (H3N2) | 8 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) | 3 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) | 8 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) | 0 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) | 0 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) | 0 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Kansas/14/2017 (H3N2) | 0 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Colorado/06/2017 (B Victoria lineage) | 0 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Kansas/14/2017 (H3N2) | 0 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) | 0 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) | 0 percentage of participants |
Secondary
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.
Time frame: Day 8, Day 29, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 8 | 17 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 90 | 5 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 29 | 17 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 29 | 7 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 8 | 17 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 90 | 5 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 57 | 8 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 118 | 11 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 90 | 2 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 57 | 8 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 8 | 27 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 57 | 3 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 57 | 0 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 29 | 17 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 57 | 5 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 57 | 13 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 118 | 8 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 8 | 29 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 118 | 25 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 118 | 22 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 8 | 10 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 8 | 24 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 90 | 2 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 29 | 10 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 118 | 8 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 90 | 7 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 29 | 15 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 118 | 19 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 90 | 10 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 29 | 5 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 90 | 17 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 29 | 19 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 29 | 25 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 8 | 27 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 8 | 32 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 8 | 14 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 8 | 41 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 8 | 38 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 8 | 27 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 29 | 14 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 29 | 22 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 29 | 14 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 29 | 19 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 57 | 11 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 57 | 11 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 57 | 8 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 57 | 8 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 57 | 19 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 57 | 11 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 90 | 6 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 90 | 11 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 90 | 11 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 90 | 6 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 90 | 6 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 118 | 10 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 118 | 13 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 118 | 10 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 118 | 17 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 118 | 17 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 118 | 10 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 29 | 18 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 8 | 38 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 90 | 3 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 29 | 18 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 29 | 33 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 90 | 5 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 29 | 5 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 29 | 3 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 90 | 24 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 8 | 10 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 118 | 18 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 90 | 3 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 8 | 38 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 8 | 25 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 118 | 18 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 8 | 28 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 118 | 18 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Oman/5532/2017 H6N1 - Day 57 | 11 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 57 | 3 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 118 | 15 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 57 | 18 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 57 | 5 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 8 | 18 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 57 | 8 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 57 | 5 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Aksaray/4048/2016 H6N2 - Day 118 | 32 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Townsville/51/2016 H6N2 - Day 90 | 5 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Louisiana/13/2017 H6N2 - Day 29 | 13 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Hubeiwujiagang/SWL310/2013 - Day 118 | 15 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms | A/Cameroon/9766/2017 H6N1 - Day 90 | 3 percentage of participants |
Secondary
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.
Time frame: Day 8, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 15 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 10 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 12 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 14 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 10 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 25 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 17 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 14 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 17 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 13 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 12 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 11 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 32 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 28 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 15 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 22 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 10 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 24 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 17 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 19 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 11 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 16 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 16 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 11 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 10 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 24 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 22 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 13 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 11 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 11 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 11 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 27 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 8 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 24 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 30 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 32 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 18 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 18 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 20 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 8 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 11 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 18 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 18 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 23 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 21 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 20 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 18 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 13 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 32 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 20 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 15 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 23 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 38 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 18 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 15 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 18 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 8 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 23 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 9 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 24 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 15 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 25 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 18 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 13 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 38 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 22 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 34 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 11 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 30 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 35 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 28 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 22 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 30 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 16 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 31 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 37 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 27 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 27 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 24 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 22 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 26 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 24 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 15 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 31 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 27 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 17 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 21 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 13 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 21 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 24 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 24 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 19 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 10 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 34 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 25 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 7 percentage of participants |
Secondary
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.
Time frame: Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 0 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 58 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 8 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 3 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 3 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 30 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 0 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 0 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 0 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 3 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 44 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 0 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 9 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 0 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 56 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 0 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 9 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 0 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 38 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 6 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) | 26 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) | 12 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) | 0 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) | 3 percentage of participants |
Secondary
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.
Time frame: Day 8, Day 29, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 0 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 12 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 15 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 13 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 34 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 12 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 47 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 5 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 33 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 7 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 7 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 19 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 20 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 17 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 15 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 24 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 13 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 19 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 12 percentage of participants |
| Fluzone | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 8 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 17 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 19 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 16 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 25 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 16 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 32 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 10 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 19 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 27 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 33 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 17 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 11 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 33 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 22 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 16 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 8 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 17 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 16 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 8 percentage of participants |
| Fluzone + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 14 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 3 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 16 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 18 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 11 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 10 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 13 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 13 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 8 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 15 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 21 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 26 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 33 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 5 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 44 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 11 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 31 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 35 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 24 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 21 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 3 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 33 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 27 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 20 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 15 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 10 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 55 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 10 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 35 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 15 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 33 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 38 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 30 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 13 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 33 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 18 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 10 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 56 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 79 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 44 percentage of participants |
| Flublok | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 32 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 49 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 49 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 35 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 34 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 22 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 11 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 43 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 8 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 24 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 42 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 72 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 51 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 8 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 69 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 24 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 22 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 44 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 8 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 41 percentage of participants |
| Flublok + AF03 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 32 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 21 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 38 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 68 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 30 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 32 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 29 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 12 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 12 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 37 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 18 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 35 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 39 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 12 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 45 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 62 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 8 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 17 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 24 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 49 percentage of participants |
| Flublok + CpG55 | Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 40 percentage of participants |
Secondary
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.
Time frame: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 78 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 98 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 98 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 95 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 90 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 98 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 1 | 54 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 1 | 78 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 90 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 85 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 95 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 98 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 94 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 98 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 83 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 83 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 78 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 88 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 1 | 78 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 1 | 78 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 94 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 95 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 95 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 93 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 78 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 97 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 90 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 83 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 94 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 97 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 1 | 86 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 1 | 68 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 93 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 89 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 1 | 81 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 94 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 97 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 89 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 1 | 81 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 95 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 95 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 78 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 92 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 88 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 73 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 1 | 70 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 1 | 70 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 1 | 43 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 1 | 68 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 98 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 98 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 88 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 93 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 97 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 97 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 95 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 87 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 92 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 97 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 95 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 82 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 82 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 92 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 92 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 95 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 74 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 79 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 94 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 94 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 97 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 94 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 1 | 56 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 95 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 97 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 95 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 97 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 1 | 80 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 90 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 93 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 88 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 98 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 97 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 88 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 1 | 80 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 95 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 95 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 1 | 90 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 71 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 88 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 1 | 74 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 79 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 95 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 89 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 92 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 76 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 95 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 92 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 1 | 66 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 89 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 1 | 47 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 71 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 76 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 1 | 71 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 95 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 84 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 78 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 90 | 85 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 57 | 88 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 1 | 86 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 69 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 8 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 8 | 93 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 29 | 90 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 57 | 90 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 8 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 57 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 8 | 86 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 118 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 29 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 1 | 83 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 95 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 90 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 1 | 81 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 90 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 118 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 118 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 95 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 29 | 95 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 90 | 93 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Louisiana/13/2017 [H3N2] - Day 1 | 52 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Kenya/105/2017 [H3N2] - Day 29 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Aksaray/4048/2016 [H3N2] - Day 57 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Michigan/84/2016 [H3N2] - Day 118 | 91 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 98 percentage of participants |
Secondary
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.
Time frame: Day 8, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 98 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 98 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 94 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 97 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 97 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 97 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 97 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 97 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 98 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 97 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 95 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 95 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 97 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 94 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 98 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 98 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 98 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 98 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 100 percentage of participants |
Secondary
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.
Time frame: Day 90 through Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 118 | 92 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 98 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 90 | 41 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 118 | 93 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 90 | 67 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 97 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 97 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 91 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 90 | 50 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 92 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 118 | 94 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 95 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 90 | 77 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 97 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 97 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 100 percentage of participants |
| Flublok | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 118 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 95 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 90 | 59 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 94 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 118 | 91 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 97 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 95 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 97 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 90 | 73 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | A/Kansas/14/2017 (H3N2) - Day 118 | 94 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 100 percentage of participants |
Secondary
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.
Time frame: Day 8, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 93 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 98 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 95 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 94 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 95 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 95 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 95 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 89 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 98 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 98 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 100 percentage of participants |
| Fluzone | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 90 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 97 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 97 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 100 percentage of participants |
| Fluzone + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 97 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 90 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 95 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 82 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 71 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 100 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 95 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 97 percentage of participants |
| Fluzone + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 89 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 100 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 100 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 95 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 97 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 100 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 100 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 100 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 100 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 100 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 100 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 85 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 100 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 95 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 90 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 100 percentage of participants |
| Flublok | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 87 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 95 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 87 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 95 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 89 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 89 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 91 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 100 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 97 percentage of participants |
| Flublok + AF03 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 94 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 98 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 97 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 100 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 95 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 93 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 98 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 93 percentage of participants |
| Flublok + CpG55 | Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 93 percentage of participants |
Secondary
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.
Time frame: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 90 | 2.5 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 57 | 2.4 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 29 | 2.4 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 90 | 1.4 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 29 | 2.4 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 8 | 2.6 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 57 | 2.3 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 8 | 1.5 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 1 | 1.9 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 118 | 1.6 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 90 | 2.1 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 1 | 1.2 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 2.4 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 2.3 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 118 | 1.1 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 1.9 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 2.4 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 118 | 1.4 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 90 | 2.3 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 57 | 2.3 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 1.6 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 57 | 1.4 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 29 | 2.4 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 8 | 2.4 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 1 | 1.9 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 29 | 1.2 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 1 | 2.1 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 118 | 1.6 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 8 | 2.5 ratio of GMT |
| Fluzone | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 2.2 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 90 | 1.1 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 1.2 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 1.6 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 1.5 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 1.4 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 1.4 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 1.4 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 1 | 1.1 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 8 | 1.5 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 29 | 1.3 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 57 | 1.3 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 90 | 1.1 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 118 | 1.4 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 1 | 1.1 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 8 | 1.4 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 29 | 1.2 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 57 | 1.2 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 90 | 1.1 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 118 | 1.1 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 1 | 1.0 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 8 | 1.2 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 29 | 1.1 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 57 | 1.2 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 118 | 1.0 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 1 | 0.8 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 8 | 0.8 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 29 | 0.8 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 57 | 0.8 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 90 | 0.8 ratio of GMT |
| Fluzone + AF03 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 118 | 0.9 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 90 | 0.7 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 8 | 1.3 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 1.0 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 118 | 0.5 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 118 | 0.8 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 57 | 0.5 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 8 | 1.1 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 90 | 0.5 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 1 | 0.6 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 1.4 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 1.1 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 1.0 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 90 | 1.0 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 118 | 0.8 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 29 | 0.9 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 8 | 0.8 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 118 | 0.9 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 57 | 0.9 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 57 | 1.0 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 1 | 0.7 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 1 | 0.7 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 90 | 0.9 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 57 | 0.7 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 1 | 0.8 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 8 | 1.3 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 1.1 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 29 | 1.1 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 0.9 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 29 | 1.1 ratio of GMT |
| Fluzone + CpG55 | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 29 | 0.6 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 29 | 1.0 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 57 | 0.9 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 29 | 0.7 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 90 | 0.8 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 1 | 0.8 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 118 | 0.7 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 118 | 0.6 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 1 | 0.8 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 0.7 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 8 | 0.9 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 57 | 0.7 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 29 | 0.8 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 0.9 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 0.7 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 57 | 0.7 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 0.9 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 90 | 0.7 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Louisiana/13/2017 [H3N2] - Day 118 | 0.5 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 0.9 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 1 | 0.8 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 90 | 0.7 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 90 | 0.9 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 57 | 0.9 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 118 | 0.7 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 8 | 0.8 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 1 | 0.7 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 29 | 0.9 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 1.1 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 8 | 1.2 ratio of GMT |
| Flublok | Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 8 | 1.1 ratio of GMT |
Secondary
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.
Time frame: Day 8, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.4 ratio of GMT |
| Fluzone | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 1.8 ratio of GMT |
| Fluzone | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 2.0 ratio of GMT |
| Fluzone | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 2.0 ratio of GMT |
| Fluzone | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1.5 ratio of GMT |
| Fluzone | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 2.1 ratio of GMT |
| Fluzone | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 1.0 ratio of GMT |
| Fluzone | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 0.9 ratio of GMT |
| Fluzone | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1.4 ratio of GMT |
| Fluzone | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 0.9 ratio of GMT |
| Fluzone | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 1.1 ratio of GMT |
| Fluzone | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 0.9 ratio of GMT |
| Fluzone | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 0.9 ratio of GMT |
| Fluzone | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 1.0 ratio of GMT |
| Fluzone | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 1.2 ratio of GMT |
| Fluzone | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1.3 ratio of GMT |
| Fluzone + AF03 | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 0.7 ratio of GMT |
| Fluzone + AF03 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1.2 ratio of GMT |
| Fluzone + AF03 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1.2 ratio of GMT |
| Fluzone + AF03 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 1.2 ratio of GMT |
| Fluzone + AF03 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 1.1 ratio of GMT |
| Fluzone + AF03 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 1.1 ratio of GMT |
| Fluzone + AF03 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 1.3 ratio of GMT |
| Fluzone + AF03 | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 0.9 ratio of GMT |
| Fluzone + AF03 | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 0.7 ratio of GMT |
| Fluzone + AF03 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 0.6 ratio of GMT |
| Fluzone + AF03 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1.2 ratio of GMT |
| Fluzone + AF03 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.1 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 0.8 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 0.9 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1.0 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 0.8 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 0.7 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 0.7 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 0.8 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 0.9 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 0.7 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 0.9 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 0.8 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 1.2 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 0.8 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 1.0 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 0.8 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 0.7 ratio of GMT |
| Flublok | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 0.8 ratio of GMT |
| Flublok | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 0.8 ratio of GMT |
| Flublok | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 0.6 ratio of GMT |
| Flublok | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 0.7 ratio of GMT |
| Flublok | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 0.7 ratio of GMT |
| Flublok | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 0.8 ratio of GMT |
| Flublok | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 0.7 ratio of GMT |
| Flublok | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 0.7 ratio of GMT |
| Flublok | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 0.8 ratio of GMT |
| Flublok | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 0.7 ratio of GMT |
| Flublok | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 0.7 ratio of GMT |
| Flublok | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 0.7 ratio of GMT |
| Flublok | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 0.8 ratio of GMT |
| Flublok | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 0.9 ratio of GMT |
| Flublok | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 0.7 ratio of GMT |
| Flublok | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 0.9 ratio of GMT |
Secondary
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.
Time frame: Day 90 through Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | 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 | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 1.0 ratio of GMT |
| Fluzone | 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 | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 0.9 ratio of GMT |
| Fluzone | 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 | A/Kansas/14/2017 (H3N2) - Day 90 | 2.0 ratio of GMT |
| Fluzone | 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 | A/Kansas/14/2017 (H3N2) - Day 118 | 1.0 ratio of GMT |
| Fluzone | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.4 ratio of GMT |
| Fluzone | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1.3 ratio of GMT |
| Fluzone | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 1.1 ratio of GMT |
| Fluzone | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 0.9 ratio of GMT |
| Fluzone + AF03 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1.2 ratio of GMT |
| Fluzone + AF03 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.1 ratio of GMT |
| Fluzone + AF03 | 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 | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 0.7 ratio of GMT |
| Fluzone + AF03 | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | A/Kansas/14/2017 (H3N2) - Day 118 | 1.3 ratio of GMT |
| Fluzone + AF03 | 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 | A/Kansas/14/2017 (H3N2) - Day 90 | 1.1 ratio of GMT |
| Fluzone + AF03 | 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 | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 0.7 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 0.8 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Kansas/14/2017 (H3N2) - Day 90 | 0.7 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Kansas/14/2017 (H3N2) - Day 118 | 0.7 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 0.7 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 0.7 ratio of GMT |
| Fluzone + CpG55 | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 0.8 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 0.9 ratio of GMT |
| Fluzone + CpG55 | 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 | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 0.8 ratio of GMT |
| Flublok | 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 | A/Kansas/14/2017 (H3N2) - Day 90 | 0.9 ratio of GMT |
| Flublok | 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 | A/Kansas/14/2017 (H3N2) - Day 118 | 0.6 ratio of GMT |
| Flublok | 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 | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 0.8 ratio of GMT |
| Flublok | 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 | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 0.8 ratio of GMT |
| Flublok | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 0.7 ratio of GMT |
| Flublok | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 0.8 ratio of GMT |
| Flublok | 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 | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 0.7 ratio of GMT |
| Flublok | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 0.9 ratio of GMT |
Secondary
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.
Time frame: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | 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 | A/Oman/5532/2017 H6N1 - Day 8 | 1.2 ratio of GMT |
| Fluzone | 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 | A/Louisiana/13/2017 H6N2 - Day 8 | 1.7 ratio of GMT |
| Fluzone | 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 | A/Aksaray/4048/2016 H6N2 - Day 8 | 1.6 ratio of GMT |
| Fluzone | 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 | A/Townsville/51/2016 H6N2 - Day 1 | 1.2 ratio of GMT |
| Fluzone | 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 | A/Townsville/51/2016 H6N2 - Day 29 | 1.6 ratio of GMT |
| Fluzone | 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 | A/Aksaray/4048/2016 H6N2 - Day 118 | 1.3 ratio of GMT |
| Fluzone | 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 | A/Cameroon/9766/2017 H6N1 - Day 29 | 1.2 ratio of GMT |
| Fluzone | 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 | A/Cameroon/9766/2017 H6N1 - Day 1 | 1.0 ratio of GMT |
| Fluzone | 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 | A/Hubeiwujiagang/SWL310/2013 - Day 29 | 1.1 ratio of GMT |
| Fluzone | 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 | A/Louisiana/13/2017 H6N2 - Day 29 | 1.7 ratio of GMT |
| Fluzone | 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 | A/Oman/5532/2017 H6N1 - Day 29 | 1.1 ratio of GMT |
| Fluzone | 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 | A/Hubeiwujiagang/SWL310/2013 - Day 1 | 1.0 ratio of GMT |
| Fluzone | 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 | A/Aksaray/4048/2016 H6N2 - Day 29 | 1.7 ratio of GMT |
| Fluzone | 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 | A/Oman/5532/2017 H6N1 - Day 118 | 1.0 ratio of GMT |
| Fluzone | 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 | A/Townsville/51/2016 H6N2 - Day 57 | 1.4 ratio of GMT |
| Fluzone | 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 | A/Oman/5532/2017 H6N1 - Day 1 | 0.9 ratio of GMT |
| Fluzone | 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 | A/Cameroon/9766/2017 H6N1 - Day 57 | 1.0 ratio of GMT |
| Fluzone | 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 | A/Louisiana/13/2017 H6N2 - Day 57 | 1.6 ratio of GMT |
| Fluzone | 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 | A/Hubeiwujiagang/SWL310/2013 - Day 57 | 1.0 ratio of GMT |
| Fluzone | 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 | A/Aksaray/4048/2016 H6N2 - Day 1 | 1.4 ratio of GMT |
| Fluzone | 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 | A/Oman/5532/2017 H6N1 - Day 57 | 1.0 ratio of GMT |
| Fluzone | 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 | A/Louisiana/13/2017 H6N2 - Day 1 | 1.2 ratio of GMT |
| Fluzone | 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 | A/Aksaray/4048/2016 H6N2 - Day 57 | 1.7 ratio of GMT |
| Fluzone | 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 | A/Townsville/51/2016 H6N2 - Day 8 | 1.5 ratio of GMT |
| Fluzone | 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 | A/Townsville/51/2016 H6N2 - Day 90 | 1.5 ratio of GMT |
| Fluzone | 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 | A/Louisiana/13/2017 H6N2 - Day 90 | 1.5 ratio of GMT |
| Fluzone | 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 | A/Cameroon/9766/2017 H6N1 - Day 90 | 1.0 ratio of GMT |
| Fluzone | 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 | A/Cameroon/9766/2017 H6N1 - Day 8 | 1.1 ratio of GMT |
| Fluzone | 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 | A/Hubeiwujiagang/SWL310/2013 - Day 90 | 1.0 ratio of GMT |
| Fluzone | 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 | A/Hubeiwujiagang/SWL310/2013 - Day 118 | 1.1 ratio of GMT |
| Fluzone | 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 | A/Oman/5532/2017 H6N1 - Day 90 | 0.9 ratio of GMT |
| Fluzone | 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 | A/Hubeiwujiagang/SWL310/2013 - Day 8 | 1.0 ratio of GMT |
| Fluzone | 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 | A/Aksaray/4048/2016 H6N2 - Day 90 | 1.6 ratio of GMT |
| Fluzone | 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 | A/Louisiana/13/2017 H6N2 - Day 118 | 1.6 ratio of GMT |
| Fluzone | 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 | A/Townsville/51/2016 H6N2 - Day 118 | 1.2 ratio of GMT |
| Fluzone | 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 | A/Cameroon/9766/2017 H6N1 - Day 118 | 1.0 ratio of GMT |
| Fluzone + AF03 | 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 | A/Townsville/51/2016 H6N2 - Day 118 | 0.9 ratio of GMT |
| Fluzone + AF03 | 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 | A/Cameroon/9766/2017 H6N1 - Day 118 | 0.7 ratio of GMT |
| Fluzone + AF03 | 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 | A/Hubeiwujiagang/SWL310/2013 - Day 118 | 0.9 ratio of GMT |
| Fluzone + AF03 | 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 | A/Oman/5532/2017 H6N1 - Day 118 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | A/Aksaray/4048/2016 H6N2 - Day 118 | 1.0 ratio of GMT |
| Fluzone + AF03 | 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 | A/Louisiana/13/2017 H6N2 - Day 1 | 1.0 ratio of GMT |
| Fluzone + AF03 | 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 | A/Louisiana/13/2017 H6N2 - Day 8 | 1.2 ratio of GMT |
| Fluzone + AF03 | 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 | A/Louisiana/13/2017 H6N2 - Day 29 | 1.1 ratio of GMT |
| Fluzone + AF03 | 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 | A/Louisiana/13/2017 H6N2 - Day 57 | 1.2 ratio of GMT |
| Fluzone + AF03 | 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 | A/Louisiana/13/2017 H6N2 - Day 90 | 1.1 ratio of GMT |
| Fluzone + AF03 | 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 | A/Louisiana/13/2017 H6N2 - Day 118 | 1.3 ratio of GMT |
| Fluzone + AF03 | 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 | A/Townsville/51/2016 H6N2 - Day 1 | 0.9 ratio of GMT |
| Fluzone + AF03 | 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 | A/Cameroon/9766/2017 H6N1 - Day 1 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | A/Hubeiwujiagang/SWL310/2013 - Day 1 | 0.9 ratio of GMT |
| Fluzone + AF03 | 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 | A/Oman/5532/2017 H6N1 - Day 1 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | A/Aksaray/4048/2016 H6N2 - Day 1 | 0.9 ratio of GMT |
| Fluzone + AF03 | 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 | A/Townsville/51/2016 H6N2 - Day 8 | 1.0 ratio of GMT |
| Fluzone + AF03 | 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 | A/Cameroon/9766/2017 H6N1 - Day 8 | 0.9 ratio of GMT |
| Fluzone + AF03 | 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 | A/Hubeiwujiagang/SWL310/2013 - Day 8 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | A/Oman/5532/2017 H6N1 - Day 8 | 0.9 ratio of GMT |
| Fluzone + AF03 | 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 | A/Aksaray/4048/2016 H6N2 - Day 8 | 1.1 ratio of GMT |
| Fluzone + AF03 | 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 | A/Townsville/51/2016 H6N2 - Day 29 | 1.1 ratio of GMT |
| Fluzone + AF03 | 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 | A/Cameroon/9766/2017 H6N1 - Day 29 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | A/Hubeiwujiagang/SWL310/2013 - Day 29 | 0.9 ratio of GMT |
| Fluzone + AF03 | 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 | A/Oman/5532/2017 H6N1 - Day 29 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | A/Aksaray/4048/2016 H6N2 - Day 29 | 1.1 ratio of GMT |
| Fluzone + AF03 | 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 | A/Townsville/51/2016 H6N2 - Day 57 | 0.9 ratio of GMT |
| Fluzone + AF03 | 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 | A/Cameroon/9766/2017 H6N1 - Day 57 | 0.7 ratio of GMT |
| Fluzone + AF03 | 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 | A/Hubeiwujiagang/SWL310/2013 - Day 57 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | A/Oman/5532/2017 H6N1 - Day 57 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | A/Aksaray/4048/2016 H6N2 - Day 57 | 1.1 ratio of GMT |
| Fluzone + AF03 | 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 | A/Townsville/51/2016 H6N2 - Day 90 | 1.1 ratio of GMT |
| Fluzone + AF03 | 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 | A/Cameroon/9766/2017 H6N1 - Day 90 | 0.7 ratio of GMT |
| Fluzone + AF03 | 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 | A/Hubeiwujiagang/SWL310/2013 - Day 90 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | A/Oman/5532/2017 H6N1 - Day 90 | 0.7 ratio of GMT |
| Fluzone + AF03 | 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 | A/Aksaray/4048/2016 H6N2 - Day 90 | 1.1 ratio of GMT |
Secondary
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.
Time frame: Day 8, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 1.1 ratio of GMT |
| Fluzone | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 1.0 ratio of GMT |
| Fluzone | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 1.0 ratio of GMT |
| Fluzone | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 0.9 ratio of GMT |
| Fluzone | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 8 | 1.5 ratio of GMT |
| Fluzone | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 57 | 1.4 ratio of GMT |
| Fluzone | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 90 | 1.4 ratio of GMT |
| Fluzone | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 118 | 1.3 ratio of GMT |
| Fluzone | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 1.1 ratio of GMT |
| Fluzone | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 1.0 ratio of GMT |
| Fluzone | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 0.9 ratio of GMT |
| Fluzone | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 0.8 ratio of GMT |
| Fluzone | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1.5 ratio of GMT |
| Fluzone | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1.5 ratio of GMT |
| Fluzone | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.5 ratio of GMT |
| Fluzone | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1.4 ratio of GMT |
| Fluzone + AF03 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1.3 ratio of GMT |
| Fluzone + AF03 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 0.9 ratio of GMT |
| Fluzone + AF03 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 0.9 ratio of GMT |
| Fluzone + AF03 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1.3 ratio of GMT |
| Fluzone + AF03 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 0.7 ratio of GMT |
| Fluzone + AF03 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 0.7 ratio of GMT |
| Fluzone + AF03 | 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 | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.3 ratio of GMT |
| Fluzone + AF03 | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 8 | 1.1 ratio of GMT |
| Fluzone + AF03 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 0.7 ratio of GMT |
| Fluzone + AF03 | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 57 | 1.0 ratio of GMT |
| Fluzone + AF03 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1.3 ratio of GMT |
| Fluzone + AF03 | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 90 | 1.0 ratio of GMT |
| Fluzone + AF03 | 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 | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 0.7 ratio of GMT |
| Fluzone + AF03 | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 118 | 1.1 ratio of GMT |
Secondary
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.
Time frame: Day 90 through Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 90 | 1.4 ratio of GMT |
| Fluzone | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 118 | 1.3 ratio of GMT |
| Fluzone | 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 | A/Kansas/14/2017 (H3N2) - Day 118 | 1.1 ratio of GMT |
| Fluzone | 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 | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 1.0 ratio of GMT |
| Fluzone | 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 | A/Kansas/14/2017 (H3N2) - Day 90 | 1.4 ratio of GMT |
| Fluzone | 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 | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 1.0 ratio of GMT |
| Fluzone | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.5 ratio of GMT |
| Fluzone | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1.4 ratio of GMT |
| Fluzone + AF03 | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 90 | 1.0 ratio of GMT |
| Fluzone + AF03 | 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 | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 0.7 ratio of GMT |
| Fluzone + AF03 | 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 | B/Colorado/06/2017 (B Victoria lineage) - Day 118 | 1.1 ratio of GMT |
| Fluzone + AF03 | 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 | A/Kansas/14/2017 (H3N2) - Day 90 | 1.0 ratio of GMT |
| Fluzone + AF03 | 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 | A/Kansas/14/2017 (H3N2) - Day 118 | 0.9 ratio of GMT |
| Fluzone + AF03 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1.3 ratio of GMT |
| Fluzone + AF03 | 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 | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 0.8 ratio of GMT |
| Fluzone + AF03 | 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 | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.3 ratio of GMT |
Secondary
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.
Time frame: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 8 | 1.8 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 1 | 1.4 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 1 | 1.6 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 1 | 1.0 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 2.7 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 8 | 2.2 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 1.8 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 8 | 1.5 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 2.5 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 29 | 1.6 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 29 | 2.0 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 29 | 1.3 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 2.5 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 57 | 2.2 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 57 | 2.0 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 57 | 1.5 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 2.7 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 90 | 1.8 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 90 | 2.1 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 90 | 1.5 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 1.5 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 118 | 1.5 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 118 | 1.3 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 118 | 1.3 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 118 | 1.1 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 1.8 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 1 | 0.7 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 118 | 1.2 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 118 | 1.6 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 57 | 1.2 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 1.7 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 1.7 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 8 | 1.4 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 57 | 1.2 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 1 | 1.2 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 57 | 0.9 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 1.4 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 29 | 1.1 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 90 | 0.9 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 1 | 1.2 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 8 | 0.9 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 29 | 1.2 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 8 | 1.2 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 90 | 1.3 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 1.2 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 29 | 0.8 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 2.0 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 90 | 1.0 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 29 | 1.2 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 8 | 1.3 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 8 | 0.8 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 1.2 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 29 | 1.3 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 1.3 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 90 | 0.6 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 29 | 0.7 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 1.1 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 57 | 1.0 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 118 | 0.9 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 57 | 1.1 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 57 | 0.6 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 118 | 0.6 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 1.2 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 90 | 1.0 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 118 | 1.0 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 0.9 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 1 | 0.9 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 90 | 1.0 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 1 | 1.0 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 1 | 0.9 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 1.5 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 8 | 1.4 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 118 | 0.8 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 118 | 0.8 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 8 | 0.8 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 1 | 0.7 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 29 | 1.0 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 29 | 1.0 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 8 | 1.0 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 1 | 0.9 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 8 | 1.2 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 29 | 1.0 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 90 | 0.7 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 1 | 1.0 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 118 | 0.7 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 57 | 0.8 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 90 | 0.9 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 57 | 0.8 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 118 | 0.6 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 57 | 0.9 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kenya/105/2017 [H3N2] - Day 8 | 1.2 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 90 | 1.0 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Shandonglaicheng/1763/2016 [H3N2] - Day 57 | 1.0 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 29 | 0.7 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/84/2016 [H3N2] - Day 1 | 0.8 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Aksaray/4048/2016 [H3N2] - Day 90 | 0.9 ratio of GMT |
Secondary
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.
Time frame: Day 8, Day 57, Day 90, Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 1.1 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 2.1 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 1.8 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 1.6 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 1.9 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 1.0 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 0.9 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 0.9 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 1.1 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 1.3 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 1.1 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 1.1 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 0.9 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1.4 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.3 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 0.9 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 0.6 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 0.8 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1.0 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 0.6 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.1 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 1.0 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 1.2 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 0.7 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 0.8 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 0.7 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 1.4 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 1.3 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 1.0 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 0.7 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 1.2 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 1.1 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 0.7 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 0.7 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 0.6 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 0.6 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 0.7 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 0.6 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 1.3 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 0.8 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 0.7 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 0.9 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 0.8 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 1.2 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 0.9 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 0.8 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 1.0 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 0.9 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 0.7 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 0.7 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90 | 0.7 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8 | 0.9 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 57 | 0.6 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 0.6 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 8 | 0.5 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57 | 0.7 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8 | 0.7 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 57 | 0.7 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57 | 0.7 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 90 | 0.7 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 0.6 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 8 | 0.9 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118 | 0.6 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Michigan/45/2015 X-275 (H1N1) - Day 118 | 0.8 ratio of GMT |
Secondary
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.
Time frame: Day 90 through Day 118
Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 1.1 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 0.9 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kansas/14/2017 (H3N2) - Day 90 | 1.6 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kansas/14/2017 (H3N2) - Day 118 | 0.8 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.3 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 0.9 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 0.9 ratio of GMT |
| Fluzone | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 0.9 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 1.0 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 1.1 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 0.7 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 0.7 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 0.7 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kansas/14/2017 (H3N2) - Day 118 | 0.9 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kansas/14/2017 (H3N2) - Day 90 | 1.1 ratio of GMT |
| Fluzone + AF03 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 0.7 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 0.6 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kansas/14/2017 (H3N2) - Day 90 | 0.8 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kansas/14/2017 (H3N2) - Day 118 | 0.7 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 0.7 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 0.6 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 0.7 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 1.2 ratio of GMT |
| Fluzone + CpG55 | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 0.9 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kansas/14/2017 (H3N2) - Day 90 | 0.9 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Kansas/14/2017 (H3N2) - Day 118 | 0.6 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118 | 0.8 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90 | 0.8 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 90 | 0.6 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118 | 0.7 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90 | 0.6 ratio of GMT |
| Flublok | Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms | B/Phuket/3073/2013 (B Yamagata lineage) - Day 118 | 0.7 ratio of GMT |