CompletedNCT04961541Updated Apr 10, 2025Results posted

Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine

A Phase 1/2 interventional study of ICC Vaccine and qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant in SARS-CoV Infection and Covid19, sponsored by Novavax. Completed at 10 sites in Australia. Open to participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-10.

Sponsored by Novavax · Phase 1/2, Interventional, and Prevention

Phase: Phase 1/2
Study type: Interventional
Enrollment: 637
Allocation: Randomized
Ages: 50 Years to 70 Years
Sex: All

Study summary

This is a randomized, observer-blinded, Phase 1/2 study evaluating the safety and immunogenicity of a quadrivalent HA nanoparticle influenza and SARS-CoV-2 rS nanoparticle combination vaccine with Matrix-M1 adjuvant; this combination is referred to as ICC vaccine.

Read the detailed description

This is a randomized, observer-blinded, Phase 1/2 study evaluating the safety and immunogenicity of a quadrivalent hemagglutinin (HA) nanoparticle influenza vaccine (qNIV) and severe acute respiratory syndrome coronavirus 2 (SARSCoV2) recombinant spike (rS) nanoparticle combination vaccine with Matrix-M1™ adjuvant; this combination vaccine is referred to as Influenza COVID-19 Combination (ICC) vaccine.

The study will enroll approximately 640 healthy (based on history and physical examination) adult male and female participants 50 to 70 years of age, inclusive, targeting participants who are baseline seropositive (either previously infected with SARS-CoV-2 ≥ 8 weeks prior to enrollment, or have been previously immunized against SARS-CoV-2 with a completed regimen of an authorized vaccine at ≥ 8 weeks prior to enrollment). Randomization will be stratified on age ≥ 50 to ≤60 or

≥ 60 to ≤ 70 years to distribute the proportions of each age stratum evenly across vaccine groups.

Conditions studied

SARS-CoV Infection
Covid19

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Keywords

Coronavirus

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 637 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Novavax is the lead sponsor of 47 studies on the registry; none are open to participants now.

Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy, medically stable adult males or females ≥ 50 to ≤ 70 years of age at screening.
Willing and able to give informed consent prior to study enrollment.
Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs.
Participants must have been baseline seropositive to SARS-CoV-2 defined as either:
- Having completed a primary vaccination series against SARS-CoV-2 with an authorized COVID-19 vaccine with receipt of second/final dose of authorized vaccine ≥ 8 weeks prior to enrollment (first study vaccination).
OR
- Previously infected with SARS CoV-2 ≥ 8 weeks prior to enrollment (first study vaccination).
Note: Baseline SARS-CoV-2 serostatus determination at screening will be based on vaccination documentation (eg, vaccination card or vaccination registry) or participants' report of a previous SARS-CoV-2 infection.
Women of childbearing potential (defined as any female participant who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study.
1. Condoms (male or female) with spermicide (if acceptable in-country)
2. Diaphragm with spermicide
3. Cervical cap with spermicide
4. Intrauterine device
5. Oral or patch contraceptives
6. Norplant®, Depo-Provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy
7. Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle
Participants must be healthy and medically stable, as determined by the investigator (based on a review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). Participants must have a body mass index (BMI) of 17 to 34 kg/m2, inclusive, at screening. Vital signs must be within medically acceptable ranges prior to the first vaccination.
Participants must agree to not participate in any other SARS-CoV-2 or influenza prevention or treatment studies for the duration of the study. Note: For participants who become hospitalized with COVID-19, participation in investigational treatment studies is permitted.

Exclusion criteria

Exclusion Criteria:

Any ongoing, symptomatic acute, or chronic illness requiring medical or surgical care.
- Asymptomatic chronic conditions or findings (eg, mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (ie, unlikely to result in symptomatic illness within the time-course of this study), in the opinion of the investigator.
- Acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable.
- Acute or chronic illnesses reasonably expected to be associated with increased risks in the event of influenza or SARS-CoV-2 infection (eg, cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable.
Participation in research involving an investigational product (drug/biologic/device) within 90 days before the planned date of the first injection.
Use of COVID-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to the planned date of the first injection.
History of a serious reaction to prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigational product.
Any history of anaphylaxis to any prior vaccine.
History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine.
Receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 2 months preceding the study vaccination. Note: Routine vaccinations will not be allowed until after study Day 70.
Any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination.
Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccines. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
Active cancer (malignancy) therapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator).
Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the EoS.
Known disturbance of coagulation.
Suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first trial vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.
Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature > 38.0°C, on the planned day of vaccine administration).
Any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
Study team member or immediate family member of any study team member (inclusive of Sponsor, Contract Research Organization, and study site personnel involved in the conduct or planning of the study).

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 637 participants (actual)

Study arms

Experimental
Group A and Group C - ICC Vaccine Formulation
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
Biological: ICC Vaccine
Experimental
Group B -ICC Vaccine Formulation
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
Biological: ICC Vaccine
Experimental
Group D - ICC Vaccine Formulation
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
Biological: ICC Vaccine
Experimental
Group E - ICC Vaccine Formulation
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
Biological: ICC Vaccine
Experimental
Group F- ICC Vaccine Formulation
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
Biological: ICC Vaccine
Experimental
Group G- ICC Vaccine Formulation
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
Biological: ICC Vaccine
Experimental
Group H and Group N- ICC Vaccine Formulation
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
Biological: ICC Vaccine
Experimental
Group I- ICC Vaccine Formulation
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
Biological: ICC Vaccine
Experimental
Group J -ICC Vaccine Formulation
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
Biological: ICC Vaccine
Experimental
Group K - ICC Vaccine Formulation
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
Biological: ICC Vaccine
Experimental
Group L - ICC Vaccine Formulation
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
Biological: ICC Vaccine
Experimental
Group M -ICC Vaccine Formulation
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
Biological: ICC Vaccine
Experimental
Group O - qNIV with Matrix-M1 adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
Biological: qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant
Experimental
Group P- SARS-CoV-2 rS with Matrix-M1 adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
Biological: SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant

Interventions

BiologicalICC Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of quadrivalent hemagglutinin nanoparticle influenza vaccine(qNIV2), SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
BiologicalqNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant
Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
BiologicalSARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant
Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.

What researchers measure

Primary outcomes

Number of Participants With Solicited Local and Systemic Adverse Events (AE's)
Numbers of participants with solicited local and systemic AEs over the 7 days post-injection after first and second doses.
Time frame: Day 0 to Day 63
Number of Participants Reporting All AE's
Number of participants reporting all AEs, (solicited and unsolicited), over 70 days after the first dose.
Time frame: Day 0 to Day 70
Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs
Number of participants with Medical Attended Adverse Events (MAAE's), Adverse events (AESI's), Including potential immune-mediated medical conditions (PIMMCs), Serious Adverse Events SAEs.
Time frame: Day 0 to Day 180

Secondary outcomes

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs)
Hemagglutination-inhibition (HAI) antibody titers specific for the hemagglutinin (HA) receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre)
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre)
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre)
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre)
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre)
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR)
Hemagglutination-Inhibition (HAI) Antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR
Hemagglutination-Inhibition (HAI) Antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR
Hemagglutination-Inhibition (HAI) Antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype)strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR)
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Time frame: Day 28 to Day 182
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Time frame: Day 28 to Day 182
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Time frame: Day 28 to Day 182
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Time frame: Day 28 to Day 182
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Time frame: Day 28 to Day 182
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Time frame: Day 28 to Day 182
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Time frame: Day 28 to Day 182
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Time frame: Day 28 to Day 182
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR).
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype)on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT)
MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 70
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR)
MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 70
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR
MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR
MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Brisbane (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Time frame: Day 0 to Day 182
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Kansas (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Time frame: Day 0 to Day 182
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Wisconsin (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Time frame: Day 0 to Day 182
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Cambodia (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Time frame: Day 0 to Day 182
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Hong Kong (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Time frame: Day 0 to Day 182
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Phuket (Yamagata Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Time frame: Day 0 to Day 182
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Maryland (Victoria Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Time frame: Day 0 to Day 182
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Washington (Victoria Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Time frame: Day 0 to Day 182
Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Brisbane (H1N1 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Kansas (H3N2 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Wisconsin (H1N1 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Cambodia (H3N2 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Hong Kong (H3N2 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza B/Maryland (Victoria Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza B/Phuket (Yamagata Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza B/Washington (Victoria Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Kansas (H3N2 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza B/Maryland (Victoria Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza B/Phuket (Yamagata Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza B/Washington (Victoria Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Brisbane (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Kansas (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Wisconsin (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Cambodia (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Hong Kong (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Maryland (Victoria Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Phuket (Yamagata Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Time frame: Day 28 to Day 182
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Washington(VictoriaSubtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Time frame: Day 28 to Day 182
Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU)
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Wuhan Strain spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Wuhan Strain spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 Variant spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Wuhan Strain spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 Variant spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR)
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 Variant spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 (Wuhan) spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182

Results

Posted Apr 10, 2025

Participant flow

Participant flow — Overall Study
Milestone	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant	Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
Started	80	40	39	37	41	41	81	39	39	40	40	41	39	40
Completed	80	40	35	36	41	40	80	38	39	38	40	41	38	40
Not completed	0	0	4	1	0	1	1	1	0	2	0	0	1	0
Withdrew: Adverse event	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Withdrew: Lost to follow-up	0	0	3	0	0	0	1	1	0	1	0	0	1	0
Withdrew: Withdrawal by subject	0	0	1	1	0	0	0	0	0	1	0	0	0	0

Outcome measures

PrimaryNumber of Participants With Solicited Local and Systemic Adverse Events (AE's)

Numbers of participants with solicited local and systemic AEs over the 7 days post-injection after first and second doses.

Time frame:: Day 0 to Day 63
Reported as:: Number · participants

Number of Participants With Solicited Local and Systemic Adverse Events (AE's)
participants	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant	Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
Local AEs	71	32	32	28	38	36	64	32	28	34	34	39	34	35
Systemic AEs	50	17	27	24	29	27	59	29	20	28	26	30	27	30

PrimaryNumber of Participants Reporting All AE's

Number of participants reporting all AEs, (solicited and unsolicited), over 70 days after the first dose.

Time frame:: Day 0 to Day 70
Reported as:: Count of participants · Participants

Number of Participants Reporting All AE's
Participants	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant	Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
Solicited AEs	77	33	35	34	39	39	70	37	31	38	34	39	38	39
Unsolicited AEs	25	15	14	17	16	20	30	9	17	19	10	16	18	14

PrimaryNumber of Participants With MAAEs, AESIs (Including PIMMCs), SAEs

Number of participants with Medical Attended Adverse Events (MAAE's), Adverse events (AESI's), Including potential immune-mediated medical conditions (PIMMCs), Serious Adverse Events SAEs.

Time frame:: Day 0 to Day 180
Reported as:: Count of participants · Participants

Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs
Participants	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant	Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
SAEs	2	1	2	0	2	1	3	2	0	0	5	0	1	1
AESIs	0	0	0	0	0	0	0	0	0	0	0	0	0	0
MAAEs	14	8	7	12	10	11	20	9	14	7	7	7	14	12

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs)

Hemagglutination-inhibition (HAI) antibody titers specific for the hemagglutinin (HA) receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.

Time frame:: Day 0 to Day 182
Reported as:: Geometric mean · Geometric Mean Titers

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs)
Geometric Mean Titers	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 0	83.6 (66.4 to 105.3)	66.7 (49.8 to 89.3)	62.4 (44.8 to 86.9)	91.2 (67.7 to 122.8)	85.6 (62.6 to 117.1)	77.3 (54.9 to 108.7)	78.3 (61.6 to 99.4)	89.8 (64.1 to 125.7)	77.9 (55.4 to 109.5)	96.8 (71.1 to 131.8)	97.3 (68.1 to 138.9)	81.4 (62.2 to 106.4)	83.6 (60.1 to 116.4)
Day 28	141.1 (116.9 to 170.4)	91.9 (67.8 to 103.8)	81.5 (63.9 to 103.8)	107.0 (83.6 to 136.8)	112.2 (84.6 to 148.8)	106.6 (78.1 to 145.6)	126.4 (103.0 to 155.2)	105.4 (79.1 to 140.4)	105.4 (61.5 to 111.8)	141.3 (107.0 to 186.6)	129.3 (93.7 to 178.3)	103.1 (80.7 to 131.7)	133.9 (104.2 to 172.2)
Day 56	129.1 (107.5 to 154.9)	86.7 (64.9 to 115.8)	84.8 (63.9 to 112.4)	100.8 (75.6 to 134.3)	100.2 (75.4 to 133.2)	95.1 (71.5 to 126.7)	107.3 (88.4 to 130.4)	94.7 (70.5 to 127.2)	73.7 (54.3 to 100.1)	126.6 (90.1 to 177.9)	109.1 (77.4 to 153.7)	99.3 (77.3 to 127.6)	118.3 (90.5 to 154.6)
Day 70	149.6 (123.6 to 181.0)	124.8 (93.9 to 165.8)	113.1 (84.4 to 151.7)	142.5 (105.7 to 192.3)	135.7 (101.3 to 181.9)	113.1 (86.7 to 147.6)	128.5 (105.2 to 157.1)	123.9 (96.6 to 159.0)	95.1 (72.8 to 124.3)	156.9 (118.8 to 207.4)	148.4 (105.6 to 208.6)	129.5 (106.9 to 157.0)	119.5 (93.0 to 153.5)
Day 84	107.7 (89.2 to 130.1)	85.1 (63.3 to 114.5)	96.1 (73.6 to 125.5)	98.5 (75.4 to 128.6)	101.7 (72.4 to 142.8)	68.5 (50.6 to 92.7)	99.1 (80.6 to 122.0)	75.1 (59.1 to 95.2)	74.4 (58.7 to 94.3)	103.2 (75.7 to 140.7)	110.0 (76.1 to 158.9)	89.3 (70.8 to 112.7)	90.1 (68.0 to 119.3)
Day 182	85.0 (69.8 to 103.4)	57.1 (41.7 to 78.1)	68.7 (51.1 to 92.2)	72.5 (54.6 to 96.1)	70.6 (51.3 to 97.3)	60.9 (43.8 to 84.5)	67.4 (53.9 to 84.3)	58.7 (43.4 to 79.5)	56.6 (43.9 to 72.9)	83.1 (57.0 to 121.2)	76.4 (53.9 to 108.3)	65.2 (49.7 to 85.6)	66.1 (48.5 to 90.0)

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs

Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.

Time frame:: Day 0 to Day 182
Reported as:: Geometric mean · Geometric Mean Titers

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs
Geometric Mean Titers	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 0	27.1 (22.7 to 32.3)	27.1 (20.4 to 35.9)	21.1 (16.0 to 27.7)	31.1 (22.9 to 42.2)	32.4 (24.3 to 43.2)	29.8 (22.8 to 38.9)	26.0 (21.3 to 31.8)	32.9 (24.5 to 44.2)	37.3 (27.5 to 50.4)	26.4 (20.9 to 33.3)	28.3 (21.3 to 37.6)	30.5 (23.5 to 39.6)	27.1 (20.2 to 36.2)
Day 28	110.7 (88.5 to 138.5)	96.8 (60.1 to 155.9)	58.1 (39.9 to 84.7)	77.1 (53.8 to 110.3)	110.3 (77.2 to 157.7)	80.7 (60.1 to 108.4)	104.9 (82.7 to 133.1)	75.8 (55.8 to 103.1)	81.4 (58.8 to 112.7)	116.2 (78.5 to 172.0)	112.1 (82.4 to 152.7)	109.4 (80.6 to 148.4)	145.1 (103.0 to 204.4)
Day 56	98.8 (78.0 to 125.0)	79.3 (50.7 to 124.0)	60.5 (41.3 to 88.6)	71.3 (49.7 to 102.3)	82.8 (58.6 to 117.1)	65.5 (49.6 to 86.7)	93.7 (74.6 to 117.6)	67.0 (48.8 to 91.9)	80.7 (59.7 to 109.1)	87.0 (57.5 to 131.8)	91.7 (64.8 to 129.9)	96.8 (69.7 to 134.5)	111.1 (79.7 to 155.1)
Day 70	122.1 (99.6 to 149.8)	115.2 (75.9 to 174.6)	77.7 (52.6 to 114.6)	111.0 (81.9 to 150.5)	127.7 (92.9 to 175.6)	98.5 (74.9 to 129.5)	125.6 (101.8 to 155.1)	104.2 (80.6 to 134.8)	102.3 (75.8 to 138.2)	115.3 (78.0 to 170.6)	111.0 (81.4 to 151.5)	113.1 (83.2 to 153.9)	116.3 (81.8 to 165.3)
Day 84	110.7 (90.3 to 135.5)	104.4 (72.2 to 151.0)	82.5 (58.1 to 117.1)	85.7 (63.5 to 115.7)	118.3 (88.3 to 158.4)	88.4 (65.6 to 119.2)	114.2 (94.7 to 137.6)	88.4 (65.6 to 119.2)	93.4 (68.9 to 126.6)	90.4 (64.6 to 126.6)	101.1 (74.2 to 137.8)	104.8 (77.6 to 141.7)	99.6 (73.2 to 135.5)
Day 182	83.8 (68.6 to 102.4)	74.5 (51.5 to 107.9)	57.7 (40.7 to 81.9)	57.1 (44.0 to 74.1)	82.2 (62.6 to 107.8)	65.5 (48.5 to 88.3)	75.0 (61.7 to 91.2)	68.2 (51.8 to 89.8)	80.0 (61.5 to 104.0)	68.6 (50.9 to 92.3)	70.4 (52.0 to 95.3)	80.7 (59.5 to 109.4)	68.5 (50.6 to 92.7)

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs

Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.

Time frame:: Day 0 to Day 182
Reported as:: Geometric mean · Geometric Mean Titers

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs
Geometric Mean Titers	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 0	96.6 (79.9 to 116.8)	85.0 (67.8 to 106.5)	87.4 (70.2 to 108.9)	100.2 (77.6 to 129.4)	90.8 (67.9 to 121.5)	96.0 (73.8 to 124.7)	102.3 (82.6 to 126.6)	89.0 (67.9 to 116.6)	108.2 (83.5 to 140.2)	104.6 (81.0 to 135.3)	111.1 (83.1 to 148.6)	87.8 (68.2 to 113.1)	115.2 (87.3 to 152.0)
Day 28	139.9 (118.1 to 165.7)	108.3 (87.3 to 134.5)	98.7 (80.6 to 120.8)	111.0 (87.2 to 141.4)	124.2 (100.0 to 154.1)	117.0 (91.2 to 150.1)	138.8 (116.3 to 165.6)	100.8 (79.4 to 127.9)	115.2 (91.9 to 144.4)	132.8 (103.2 to 170.9)	130.4 (98.7 to 172.3)	114.1 (89.8 to 144.9)	146.4 (117.3 to 182.7)
Day 56	127.4 (106.8 to 151.8)	95.6 (75.3 to 121.3)	93.3 (73.9 to 117.9)	105.8 (81.7 to 136.9)	107.4 (82.9 to 139.2)	100.2 (77.1 to 130.3)	119.3 (101.4 to 140.2)	98.1 (77.6 to 124.1)	102.3 (79.7 to 131.4)	126.6 (98.2 to 163.2)	119.5 (91.2 to 156.7)	98.5 (78.8 to 123.1)	135.1 (104.2 to 175.3)
Day 70	148.2 (123.4 to 178.0)	109.2 (87.4 to 136.4)	107.7 (85.3 to 135.9)	125.8 (98.4 to 160.8)	140.5 (107.5 to 183.6)	107.4 (84.3 to 136.9)	138.9 (116.5 to 165.6)	114.2 (90.8 to 143.5)	110.1 (88.9 to 136.4)	146.7 (114.7 to 187.7)	140.3 (108.2 to 182.1)	121.1 (99.8 to 146.8)	137.0 (105.2 to 178.5)
Day 84	87.4 (73.2 to 104.5)	68.2 (53.8 to 86.3)	62.6 (47.8 to 82.1)	69.6 (53.0 to 91.5)	81.4 (62.0 to 107.0)	72.4 (54.7 to 95.8)	86.4 (71.0 to 105.3)	66.7 (52.1 to 85.3)	58.7 (46.1 to 74.7)	79.2 (57.3 to 109.3)	79.3 (55.7 to 112.7)	74.1 (58.4 to 94.0)	75.7 (57.1 to 100.4)
Day 182	70.9 (59.1 to 85.2)	50.4 (40.7 to 62.5)	50.6 (38.4 to 66.5)	57.1 (48.2 to 76.3)	65.2 (49.8 to 85.4)	60.3 (45.9 to 79.2)	65.0 (53.6 to 78.7)	54.0 (41.6 to 70.1)	49.6 (39.2 to 62.8)	70.6 (52.8 to 94.4)	60.9 (44.5 to 83.3)	61.3 (48.0 to 78.3)	64.9 (48.6 to 86.6)

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs

Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.

Time frame:: Day 0 to Day 182
Reported as:: Geometric mean · Geometric Mean Titers

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs
Geometric Mean Titers	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 0	43.9 (36.6 to 52.5)	41.8 (31.3 to 55.7)	40.4 (30.1 to 54.2)	42.3 (32.8 to 54.6)	42.1 (32.5 to 54.4)	45.6 (35.2 to 58.9)	35.5 (29.7 to 42.5)	40.7 (30.0 to 55.2)	46.1 (34.0 to 62.5)	36.4 (27.8 to 47.6)	45.3 (34.1 to 60.1)	41.4 (32.4 to 52.8)	46.9 (35.3 to 62.4)
Day 28	98.1 (77.3 to 124.4)	90.3 (55.7 to 146.3)	67.9 (46.8 to 98.4)	70.2 (51.2 to 96.2)	93.9 (64.9 to 135.9)	84.2 (63.8 to 110.9)	78.2 (61.7 to 99.2)	66.4 (47.1 to 93.5)	79.3 (55.8 to 112.7)	89.0 (59.1 to 134.1)	110.2 (76.9 to 157.8)	76.0 (56.0 to 103.2)	104.4 (77.4 to 141.0)
Day 56	85.8 (66.9 to 110.1)	80.0 (5.0 to 2560.0)	68.3 (5.0 to 640.0)	48.3 (10.0 to 640.0)	73.4 (53.1 to 101.3)	80.0 (10.0 to 1280.0)	68.0 (53.8 to 85.9)	40.0 (5.0 to 640.0)	40.0 (5.0 to 640.0)	79.3 (51.1 to 123.0)	88.4 (59.5 to 131.5)	64.4 (47.1 to 88.1)	89.0 (65.0 to 121.9)
Day 70	94.5 (75.3 to 118.6)	92.2 (58.6 to 145.3)	78.4 (53.3 to 115.4)	74.1 (53.9 to 101.9)	92.7 (67.6 to 127.2)	85.7 (63.8 to 115.2)	78.2 (62.0 to 98.6)	83.0 (59.6 to 115.6)	77.1 (52.9 to 112.6)	85.6 (56.7 to 129.1)	97.4 (67.7 to 140.1)	79.3 (59.4 to 105.9)	94.3 (70.0 to 127.0)
Day 84	56.8 (45.0 to 71.7)	65.2 (42.3 to 100.6)	48.1 (33.0 to 69.9)	45.5 (32.1 to 64.5)	57.1 (40.7 to 80.1)	55.5 (40.3 to 76.6)	50.7 (40.4 to 63.6)	51.6 (36.8 to 72.4)	48.4 (33.3 to 70.6)	53.8 (35.0 to 82.7)	70.8 (48.7 to 102.9)	46.6 (34.4 to 63.0)	51.2 (36.6 to 71.6)
Day 182	50.4 (40.5 to 62.7)	55.6 (36.2 to 85.4)	38.0 (25.7 to 56.2)	33.5 (23.7 to 47.2)	45.7 (33.9 to 61.6)	42.6 (31.0 to 58.6)	38.0 (30.6 to 47.3)	44.8 (31.6 to 63.4)	46.0 (32.9 to 64.5)	44.9 (31.3 to 64.4)	47.6 (33.3 to 68.0)	38.6 (28.6 to 52.1)	41.9 (30.1 to 58.2)

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs

Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.

Time frame:: Day 0 to Day 182
Reported as:: Geometric mean · Geometric Mean Titers

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs
Geometric Mean Titers	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 0	71.4 (61.1 to 83.4)	69.6 (55.0 to 88.2)	68.2 (53.4 to 87.0)	70.8 (54.6 to 91.9)	78.0 (62.0 to 98.2)	79.3 (60.5 to 104.0)	58.6 (49.6 to 69.2)	73.2 (56.5 to 94.8)	77.2 (58.0 to 102.8)	56.6 (45.2 to 70.8)	81.4 (63.2 to 105.0)	67.6 (52.6 to 86.7)	74.5 (57.1 to 97.3)
Day 28	134.0 (110.9 to 161.8)	126.6 (83.9 to 191.2)	98.7 (73.3 to 132.8)	100.2 (73.9 to 135.9)	134.0 (95.0 to 189.0)	113.1 (88.6 to 144.5)	115.7 (95.0 to 140.9)	107.3 (82.0 to 140.3)	125.9 (91.5 to 173.2)	117.2 (86.4 to 159.0)	150.4 (107.1 to 211.0)	117.0 (88.5 to 154.8)	142.5 (107.2 to 189.6)
Day 56	121.9 (99.4 to 149.6)	111.1 (74.1 to 166.6)	91.5 (68.1 to 123.0)	95.1 (69.7 to 129.9)	102.9 (76.3 to 138.7)	110.2 (84.0 to 144.7)	104.1 (85.2 to 127.2)	93.9 (70.2 to 125.5)	113.1 (82.8 to 154.6)	95.6 (68.7 to 133.1)	130.9 (94.3 to 181.8)	103.7 (79.6 to 135.3)	121.5 (92.2 to 160.0)
Day 70	137.9 (112.2 to 169.5)	142.5 (95.4 to 212.9)	115.4 (83.4 to 159.8)	117.6 (89.4 to 154.7)	131.1 (96.9 to 177.3)	127.7 (98.0 to 166.5)	112.1 (91.6 to 137.1)	112.1 (85.7 to 146.6)	123.9 (88.1 to 174.3)	111.0 (82.0 to 150.3)	155.0 (111.2 to 216.2)	115.1 (86.8 to 152.6)	132.1 (101.4 to 172.1)
Day 84	88.6 (70.5 to 111.3)	99.0 (66.4 to 147.6)	76.0 (51.4 to 112.4)	80.8 (57.3 to 113.9)	97.3 (69.2 to 136.8)	90.9 (64.8 to 127.5)	86.8 (69.5 to 108.5)	83.7 (60.3 to 116.3)	83.7 (58.1 to 120.8)	79.2 (52.7 to 118.9)	113.1 (77.0 to 166.3)	93.1 (68.4 to 126.8)	87.6 (64.6 to 118.9)
Day 182	72.6 (58.6 to 89.9)	81.4 (54.3 to 122.1)	59.5 (42.1 to 84.2)	62.5 (44.6 to 87.5)	77.9 (57.1 to 106.3)	69.8 (50.3 to 96.8)	61.8 (50.3 to 75.8)	69.5 (50.7 to 95.3)	74.9 (53.8 to 104.3)	66.6 (48.4 to 91.7)	85.3 (60.1 to 120.9)	72.5 (52.2 to 100.8)	73.0 (53.7 to 99.3)

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs

Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.

Time frame:: Day 0 to Day 182
Reported as:: Geometric mean · Geometric Mean Titers

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs
Geometric Mean Titers	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 0	46.6 (38.7 to 56.2)	40.3 (31.1 to 52.3)	36.6 (36.6 to 48.8)	39.3 (30.9 to 49.9)	34.6 (27.0 to 44.4)	36.4 (27.6 to 47.9)	38.1 (31.2 to 46.6)	41.4 (31.5 to 54.6)	38.9 (28.2 to 53.7)	45.9 (34.9 to 60.5)	41.1 (31.8 to 53.1)	42.1 (32.9 to 53.8)	36.0 (26.8 to 48.2)
Day 28	73.7 (62.3 to 87.2)	63.3 (48.0 to 83.5)	40.7 (31.2 to 53.2)	52.0 (40.1 to 67.4)	53.3 (40.2 to 70.8)	47.0 (36.3 to 60.7)	61.0 (51.0 to 73.0)	49.1 (37.7 to 63.9)	45.3 (33.4 to 61.4)	59.7 (46.4 to 76.8)	56.6 (42.6 to 75.1)	58.0 (44.9 to 75.0)	65.8 (48.4 to 89.5)
Day 56	69.5 (58.1 to 83.2)	54.6 (41.3 to 72.1)	43.6 (32.7 to 58.2)	55.5 (43.1 to 71.5)	42.5 (31.7 to 56.9)	44.8 (34.7 to 57.7)	57.3 (47.7 to 68.8)	47.8 (37.4 to 61.0)	44.6 (33.4 to 59.6)	57.1 (44.0 to 74.1)	48.4 (36.2 to 64.8)	52.3 (41.0 to 66.7)	58.1 (43.8 to 77.0)
Day 70	77.5 (64.8 to 92.8)	65.2 (48.5 to 87.8)	47.8 (34.6 to 66.1)	61.1 (47.4 to 78.8)	58.1 (44.2 to 76.3)	50.5 (39.5 to 64.7)	63.4 (53.3 to 75.4)	55.5 (41.6 to 74.1)	50.7 (38.9 to 66.1)	66.0 (50.5 to 86.1)	60.4 (45.2 to 80.8)	64.2 (50.5 to 81.6)	58.1 (43.6 to 77.5)
Day 84	76.2 (63.2 to 91.9)	69.4 (54.5 to 88.3)	56.6 (41.9 to 76.4)	57.7 (44.1 to 75.4)	61.8 (47.8 to 80.0)	56.6 (43.4 to 73.7)	74.0 (62.5 to 87.7)	51.6 (39.1 to 68.1)	52.1 (39.9 to 68.0)	65.2 (48.8 to 87.2)	67.6 (51.9 to 88.0)	65.3 (51.3 to 83.1)	63.1 (49.4 to 80.6)
Day 182	71.3 (59.5 to 85.3)	60.2 (47.9 to 75.7)	49.0 (37.0 to 65.0)	50.7 (37.7 to 68.2)	52.2 (40.8 to 66.9)	48.0 (37.0 to 62.3)	62.6 (52.1 to 75.2)	49.6 (38.0 to 64.7)	52.0 (41.0 to 66.0)	55.5 (42.0 to 73.3)	54.0 (40.5 to 72.2)	55.1 (43.7 to 69.4)	56.1 (43.9 to 71.5)

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs

Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.

Time frame:: Day 0 to Day 182
Reported as:: Geometric mean · Geometric Mean Titers

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs
Geometric Mean Titers	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 0	40.4 (33.7 to 48.3)	36.1 (27.1 to 47.9)	24.3 (18.3 to 32.4)	33.2 (24.4 to 45.2)	35.8 (27.5 to 46.7)	35.4 (26.4 to 47.6)	31.3 (25.7 to 38.1)	38.3 (29.6 to 49.4)	36.9 (28.9 to 47.2)	36.1 (29.0 to 44.8)	33.5 (26.9 to 41.7)	35.5 (27.8 to 45.5)	40.0 (5.0 to 640.0)
Day 28	78.3 (65.2 to 93.9)	57.6 (43.5 to 76.2)	35.2 (26.7 to 46.4)	47.8 (36.6 to 62.4)	67.6 (53.0 to 86.2)	50.7 (39.1 to 65.7)	58.1 (48.5 to 69.6)	60.2 (47.8 to 75.8)	48.6 (38.1 to 62.0)	59.7 (48.2 to 73.9)	57.6 (45.9 to 72.2)	68.7 (53.3 to 88.6)	100.8 (81.8 to 124.1)
Day 56	72.3 (60.5 to 86.4)	53.2 (40.0 to 70.7)	36.0 (26.7 to 48.5)	44.5 (33.6 to 58.8)	58.6 (45.0 to 76.3)	47.2 (36.2 to 61.4)	52.7 (43.8 to 63.4)	57.1 (45.8 to 71.1)	44.6 (35.8 to 55.6)	55.5 (43.9 to 70.3)	49.8 (39.1 to 63.3)	62.2 (48.4 to 80.1)	86.7 (69.2 to 108.6)
Day 70	87.9 (71.9 to 107.6)	72.5 (55.4 to 94.9)	45.0 (32.8 to 61.9)	61.7 (48.1 to 79.1)	84.3 (64.8 to 109.6)	59.1 (46.2 to 75.5)	65.8 (54.6 to 79.2)	67.9 (54.4 to 84.7)	56.1 (44.6 to 70.5)	69.9 (54.1 to 90.4)	63.3 (49.9 to 80.3)	74.1 (58.6 to 93.8)	85.3 (66.8 to 108.8)
Day 84	86.7 (73.0 to 102.9)	71.9 (57.2 to 90.4)	52.1 (39.9 to 68.1)	60.6 (46.8 to 78.6)	87.4 (69.8 to 109.6)	63.7 (51.3 to 79.0)	72.7 (60.9 to 86.7)	65.5 (53.3 to 80.3)	60.3 (47.9 to 75.9)	73.0 (56.0 to 95.1)	72.8 (57.1 to 92.9)	76.7 (61.0 to 96.4)	89.3 (72.3 to 110.2)
Day 182	77.1 (64.4 to 92.3)	61.3 (49.3 to 76.2)	43.8 (33.4 to 57.6)	53.3 (41.3 to 68.7)	70.0 (54.9 to 89.2)	52.6 (41.1 to 67.3)	55.5 (46.8 to 65.9)	57.1 (46.8 to 69.7)	54.5 (44.1 to 67.3)	61.7 (50.7 to 75.1)	54.0 (42.9 to 68.1)	60.7 (49.0 to 75.3)	68.5 (55.3 to 84.9)

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs

Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.

Time frame:: Day 0 to Day 182
Reported as:: Geometric mean · Geometric Mean Titers

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs
Geometric Mean Titers	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 0	75.9 (65.7 to 87.7)	67.9 (54.4 to 84.6)	75.8 (60.7 to 94.7)	67.6 (54.5 to 83.8)	62.1 (49.2 to 78.3)	65.5 (52.3 to 82.1)	69.5 (59.9 to 80.7)	65.2 (50.9 to 83.5)	67.6 (51.3 to 89.1)	72.7 (56.3 to 93.9)	75.2 (60.9 to 92.8)	74.8 (60.1 to 93.1)	64.6 (51.9 to 80.5)
Day 28	101.5 (88.4 to 116.6)	84.3 (67.8 to 104.7)	82.2 (65.0 to 103.9)	81.5 (64.5 to 103.0)	83.5 (67.0 to 103.9)	78.0 (63.0 to 96.6)	89.4 (75.3 to 106.2)	73.9 (58.8 to 92.8)	75.8 (58.9 to 97.7)	87.4 (68.7 to 111.3)	88.2 (67.4 to 115.4)	90.8 (71.3 to 115.7)	99.9 (80.2 to 124.4)
Day 56	91.7 (79.2 to 106.1)	83.6 (66.3 to 105.5)	73.4 (57.6 to 93.4)	80.8 (64.1 to 101.9)	70.3 (56.6 to 87.1)	70.3 (56.0 to 88.1)	85.4 (72.6 to 100.5)	70.0 (55.5 to 88.4)	77.1 (59.8 to 99.6)	77.8 (61.0 to 99.1)	82.2 (62.9 to 107.5)	85.7 (69.0 to 106.6)	91.4 (72.8 to 114.7)
Day 70	107.2 (92.8 to 123.8)	89.8 (69.0 to 116.8)	88.3 (68.6 to 113.7)	91.5 (71.3 to 117.5)	85.0 (66.5 to 108.7)	77.3 (62.1 to 96.1)	93.4 (79.0 to 110.4)	75.1 (60.1 to 93.6)	80.7 (60.9 to 107.0)	95.1 (76.0 to 119.2)	92.9 (70.5 to 122.4)	90.8 (74.3 to 111.1)	94.3 (73.7 to 120.6)
Day 84	63.5 (53.5 to 75.4)	62.4 (48.0 to 81.1)	57.1 (42.5 to 76.8)	54.9 (41.9 to 72.0)	58.6 (46.0 to 74.7)	48.4 (38.8 to 60.5)	66.1 (54.9 to 79.5)	48.4 (36.0 to 65.3)	50.2 (37.6 to 67.1)	58.3 (43.8 to 77.6)	67.0 (51.3 to 87.4)	63.1 (50.0 to 79.7)	65.5 (49.4 to 86.7)
Day 182	61.2 (51.8 to 72.3)	52.7 (40.7 to 68.2)	50.6 (37.4 to 68.4)	49.7 (37.4 to 66.1)	48.2 (37.5 to 62.0)	43.4 (34.2 to 55.1)	55.8 (46.2 to 67.3)	45.6 (34.5 to 60.2)	50.1 (39.2 to 63.9)	56.0 (43.5 to 72.2)	51.6 (38.4 to 69.4)	57.1 (45.0 to 72.3)	58.7 (44.6 to 77.1)

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre)

Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.

Time frame:: Day 28 to Day 182
Reported as:: Geometric mean · geometric mean fold rise

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre)
geometric mean fold rise	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 28	1.7 (1.4 to 2.0)	1.4 (1.0 to 1.4)	1.3 (1.1 to 1.6)	1.2 (1.0 to 1.4)	1.3 (1.0 to 1.6)	1.3 (1.1 to 1.5)	1.6 (1.4 to 1.8)	1.2 (1.0 to 1.4)	1.1 (0.9 to 1.2)	1.5 (1.2 to 1.8)	1.3 (1.1 to 1.6)	1.3 (1.1 to 1.5)	1.6 (1.3 to 2.0)
Day 56	1.5 (1.3 to 1.8)	1.3 (1.0 to 1.8)	1.3 (1.0 to 1.6)	1.1 (1.0 to 1.2)	1.1 (1.0 to 1.3)	1.2 (1.1 to 1.4)	1.4 (1.2 to 1.6)	1.1 (0.9 to 1.3)	1.0 (0.9 to 1.2)	1.3 (1.0 to 1.6)	1.1 (0.9 to 1.4)	1.2 (1.1 to 1.5)	1.4 (1.1 to 1.8)
Day 70	1.7 (1.4 to 2.1)	1.9 (1.4 to 2.6)	1.7 (1.4 to 2.1)	1.6 (1.3 to 1.9)	1.5 (1.2 to 1.9)	1.5 (1.2 to 1.8)	1.6 (1.4 to 1.9)	1.4 (1.1 to 1.7)	1.3 (1.1 to 1.6)	1.5 (1.2 to 1.9)	1.5 (1.2 to 1.9)	1.6 (1.3 to 1.9)	1.5 (1.2 to 1.8)
Day 84	1.3 (1.0 to 1.6)	1.3 (0.9 to 1.8)	1.4 (1.1 to 1.7)	1.1 (0.9 to 1.3)	1.1 (0.9 to 1.5)	0.9 (0.7 to 1.2)	1.3 (1.1 to 1.5)	0.8 (0.6 to 1.0)	1.0 (0.8 to 1.3)	1.0 (0.8 to 1.2)	1.1 (0.8 to 1.4)	1.1 (0.9 to 1.4)	1.1 (0.8 to 1.5)
Day 182	1.0 (0.8 to 1.3)	0.9 (0.6 to 1.2)	1.0 (0.8 to 1.2)	0.8 (0.7 to 0.9)	0.8 (0.6 to 1.0)	0.8 (0.6 to 1.0)	0.9 (0.7 to 1.0)	0.6 (0.5 to 0.8)	0.8 (0.6 to 0.9)	0.8 (0.6 to 1.0)	0.8 (0.6 to 1.0)	0.8 (0.7 to 1.0)	0.8 (0.6 to 1.0)

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre)

Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.

Time frame:: Day 28 to Day 182
Reported as:: Geometric mean · geometric mean fold rise

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre)
geometric mean fold rise	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 28	4.1 (3.3 to 4.9)	3.6 (2.3 to 5.5)	2.7 (2.1 to 3.5)	2.5 (1.9 to 3.2)	3.4 (2.4 to 4.7)	2.7 (2.0 to 3.5)	4.1 (3.3 to 5.0)	2.3 (1.8 to 3.0)	2.2 (1.7 to 2.8)	4.4 (3.1 to 6.1)	4.0 (3.2 to 5.0)	3.6 (2.7 to 4.8)	5.4 (3.8 to 7.5)
Day 56	3.6 (3.0 to 4.4)	3.0 (2.0 to 4.4)	2.9 (2.2 to 3.7)	2.2 (1.8 to 2.8)	2.6 (1.9 to 3.6)	2.2 (1.7 to 2.8)	3.6 (3.0 to 4.4)	2.0 (1.6 to 2.6)	2.1 (1.6 to 2.8)	3.3 (2.4 to 4.5)	3.2 (2.5 to 4.1)	3.2 (2.5 to 4.2)	4.1 (3.1 to 5.5)
Day 70	4.5 (3.7 to 5.4)	4.3 (2.9 to 6.4)	3.8 (2.7 to 5.2)	3.5 (2.8 to 4.3)	4.0 (2.9 to 5.4)	3.3 (2.5 to 4.3)	4.8 (3.9 to 5.9)	3.1 (2.4 to 4.0)	2.7 (2.1 to 3.5)	4.4 (3.1 to 6.2)	3.8 (3.0 to 4.7)	3.7 (2.8 to 4.8)	4.2 (3.0 to 5.8)
Day 84	4.1 (3.4 to 4.9)	3.9 (2.7 to 5.6)	3.9 (3.1 to 5.0)	2.6 (2.1 to 3.3)	3.6 (2.6 to 4.9)	2.8 (2.1 to 3.7)	4.4 (3.6 to 5.4)	2.6 (2.1 to 3.2)	2.5 (1.9 to 3.2)	3.5 (2.8 to 4.3)	3.4 (2.7 to 4.3)	3.4 (2.7 to 4.4)	3.6 (2.7 to 4.8)
Day 182	3.1 (2.6 to 3.7)	2.8 (2.0 to 3.9)	2.8 (2.2 to 3.5)	1.8 (1.4 to 2.2)	2.5 (1.9 to 3.2)	2.2 (1.6 to 3.0)	3.0 (2.5 to 3.6)	2.1 (1.7 to 2.6)	2.1 (1.7 to 2.5)	2.6 (2.1 to 3.2)	2.5 (2.0 to 3.1)	2.8 (2.2 to 3.5)	2.5 (1.9 to 3.3)

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre)

Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.

Time frame:: Day 28 to Day 182
Reported as:: Geometric mean · geometric mean fold rise

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre)
geometric mean fold rise	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 28	1.4 (1.3 to 1.6)	1.3 (1.1 to 1.5)	1.2 (1.0 to 1.3)	1.1 (1.0 to 1.2)	1.4 (1.2 to 1.6)	1.2 (1.1 to 1.3)	1.4 (1.2 to 1.5)	1.1 (1.0 to 1.3)	1.1 (0.9 to 1.2)	1.3 (1.1 to 1.5)	1.2 (1.1 to 1.3)	1.3 (1.1 to 1.5)	1.3 (1.1 to 1.5)
Day 56	1.3 (1.2 to 1.5)	1.1 (0.9 to 1.4)	1.1 (0.9 to 1.2)	1.0 (1.0 to 1.2)	1.1 (1.0 to 1.3)	1.0 (0.9 to 1.2)	1.2 (1.0 to 1.3)	1.1 (0.9 to 1.3)	1.0 (0.9 to 1.1)	1.2 (1.0 to 1.4)	1.1 (1.0 to 1.2)	1.1 (1.0 to 1.3)	1.2 (1.0 to 1.4)
Day 70	1.5 (1.3 to 1.8)	1.3 (1.0 to 1.6)	1.2 (1.1 to 1.4)	1.2 (1.1 to 1.4)	1.5 (1.2 to 1.8)	1.1 (1.0 to 1.3)	1.4 (1.2 to 1.5)	1.3 (1.1 to 1.5)	1.1 (1.0 to 1.2)	1.3 (1.1 to 1.6)	1.2 (1.1 to 1.4)	1.4 (1.2 to 1.6)	1.2 (1.0 to 1.4)
Day 84	0.9 (0.8 to 1.0)	0.8 (0.6 to 1.0)	0.7 (0.6 to 0.8)	0.7 (0.6 to 0.8)	0.9 (0.7 to 1.0)	0.8 (0.6 to 1.0)	0.8 (0.7 to 1.0)	0.7 (0.6 to 0.9)	0.6 (0.5 to 0.7)	0.7 (0.5 to 0.9)	0.7 (0.6 to 0.8)	0.8 (0.7 to 1.0)	0.7 (0.6 to 0.8)
Day 182	0.8 (0.6 to 0.9)	0.6 (0.5 to 0.7)	0.6 (0.5 to 0.7)	0.6 (0.5 to 0.7)	0.7 (0.6 to 0.8)	0.6 (0.5 to 0.8)	0.7 (0.6 to 0.7)	0.6 (0.5 to 0.7)	0.5 (0.4 to 0.6)	0.6 (0.5 to 0.8)	0.6 (0.5 to 0.6)	0.7 (0.6 to 0.8)	0.6 (0.5 to 0.7)

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre)

Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.

Time frame:: Day 28 to Day 182
Reported as:: Geometric mean · geometric mean fold rise

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre)
geometric mean fold rise	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 28	2.2 (1.9 to 2.6)	2.2 (1.4 to 3.2)	1.7 (1.3 to 2.1)	1.7 (1.3 to 2.0)	2.2 (1.6 to 3.0)	1.8 (1.4 to 2.4)	2.2 (1.9 to 2.6)	1.6 (1.3 to 2.0)	1.7 (1.4 to 2.1)	2.4 (1.8 to 3.3)	2.4 (1.9 to 3.0)	1.8 (1.5 to 2.3)	2.2 (1.7 to 3.0)
Day 56	1.9 (1.6 to 2.3)	1.9 (1.3 to 2.7)	1.6 (1.3 to 2.0)	1.5 (1.2 to 1.9)	1.8 (1.4 to 2.3)	1.6 (1.3 to 1.9)	1.9 (1.6 to 2.2)	1.5 (1.2 to 1.8)	1.5 (1.2 to 1.9)	2.2 (1.6 to 3.1)	2.0 (1.6 to 2.5)	1.6 (1.3 to 2.1)	1.9 (1.5 to 2.5)
Day 70	2.1 (1.8 to 2.5)	2.2 (1.5 to 3.2)	1.9 (1.5 to 2.4)	1.7 (1.4 to 2.1)	2.2 (1.7 to 3.0)	1.9 (1.5 to 2.4)	2.2 (1.8 to 2.5)	1.9 (1.6 to 2.4)	1.7 (1.3 to 2.1)	2.5 (1.8 to 3.5)	2.1 (1.7 to 2.7)	1.9 (1.5 to 2.4)	2.1 (1.6 to 2.6)
Day 84	1.3 (1.1 to 1.5)	1.6 (1.1 to 2.3)	1.2 (0.9 to 1.5)	1.1 (0.8 to 1.4)	1.4 (1.0 to 1.8)	1.2 (0.9 to 1.6)	1.4 (1.2 to 1.7)	1.2 (1.0 to 1.5)	1.0 (0.8 to 1.4)	1.6 (1.2 to 2.2)	1.6 (1.2 to 1.9)	1.1 (0.9 to 1.4)	1.1 (0.9 to 1.4)
Day 182	1.2 (1.0 to 1.4)	1.3 (0.9 to 1.9)	0.9 (0.7 to 1.2)	0.8 (0.6 to 1.0)	1.1 (0.8 to 1.4)	0.9 (0.7 to 1.2)	1.1 (0.9 to 1.3)	1.0 (0.8 to 1.2)	1.0 (0.8 to 1.2)	1.3 (1.0 to 1.7)	1.1 (0.8 to 1.4)	0.9 (0.8 to 1.2)	0.9 (0.7 to 1.2)

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre)

Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.

Time frame:: Day 28 to Day 182
Reported as:: Geometric mean · geometric mean fold rise

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre)
geometric mean fold rise	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 28	1.9 (1.6 to 2.2)	1.8 (1.3 to 2.5)	1.4 (1.2 to 1.7)	1.4 (1.2 to 1.7)	1.7 (1.3 to 2.2)	1.4 (1.2 to 1.7)	1.9 (1.7 to 2.3)	1.5 (1.2 to 1.7)	1.6 (1.4 to 2.0)	2.1 (1.7 to 2.5)	1.8 (1.5 to 2.3)	1.7 (1.4 to 2.1)	1.9 (1.4 to 2.5)
Day 56	1.7 (1.5 to 2.0)	1.6 (1.2 to 2.2)	1.4 (1.2 to 1.6)	1.3 (1.1 to 1.6)	1.3 (1.1 to 1.6)	1.4 (1.2 to 1.6)	1.8 (1.5 to 2.1)	1.3 (1.1 to 1.5)	1.5 (1.2 to 1.7)	1.7 (1.4 to 2.1)	1.6 (1.3 to 2.0)	1.6 (1.3 to 1.9)	1.6 (1.3 to 2.1)
Day 70	1.9 (1.6 to 2.2)	2.1 (1.5 to 2.8)	1.8 (1.4 to 2.2)	1.6 (1.3 to 2.0)	1.7 (1.4 to 2.1)	1.6 (1.3 to 1.9)	1.9 (1.6 to 2.2)	1.5 (1.2 to 1.8)	1.6 (1.3 to 1.9)	2.0 (1.7 to 2.5)	1.9 (1.5 to 2.4)	1.7 (1.4 to 2.1)	1.8 (1.4 to 2.2)
Day 84	1.2 (1.1 to 1.5)	1.4 (1.1 to 1.9)	1.1 (0.9 to 1.5)	1.1 (0.9 to 1.4)	1.2 (1.0 to 1.6)	1.1 (0.9 to 1.4)	1.5 (1.2 to 1.8)	1.1 (0.9 to 1.3)	1.1 (0.8 to 1.4)	1.5 (1.1 to 2.0)	1.4 (1.1 to 1.7)	1.4 (1.1 to 1.8)	1.2 (0.9 to 1.5)
Day 182	1.0 (0.9 to 1.2)	1.2 (0.8 to 1.6)	0.9 (0.7 to 1.1)	0.9 (0.7 to 1.1)	1.0 (0.8 to 1.2)	0.9 (0.7 to 1.2)	1.1 (0.9 to 1.3)	0.9 (0.8 to 1.1)	1.0 (0.8 to 1.2)	1.2 (1.0 to 1.5)	1.1 (0.9 to 1.3)	1.1 (0.8 to 1.4)	1.0 (0.8 to 1.3)

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre)

Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.

Time frame:: Day 28 to Day 182
Reported as:: Geometric mean · geometric mean fold rise

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre)
geometric mean fold rise	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 28	1.6 (1.4 to 1.9)	1.6 (1.3 to 2.0)	1.1 (0.9 to 1.4)	1.3 (1.1 to 1.6)	1.5 (1.2 to 1.9)	1.3 (1.1 to 1.5)	1.6 (1.4 to 1.9)	1.2 (1.0 to 1.3)	1.2 (1.0 to 1.3)	1.3 (1.1 to 1.6)	1.4 (1.1 to 1.7)	1.4 (1.2 to 1.6)	1.8 (1.4 to 2.4)
Day 56	1.5 (1.3 to 1.8)	1.3 (1.1 to 1.6)	1.2 (1.0 to 1.4)	1.4 (1.2 to 1.6)	1.2 (1.0 to 1.5)	1.2 (1.1 to 1.4)	1.5 (1.3 to 1.7)	1.2 (1.0 to 1.3)	1.1 (1.0 to 1.3)	1.3 (1.1 to 1.6)	1.2 (1.0 to 1.4)	1.3 (1.2 to 1.4)	1.6 (1.3 to 2.0)
Day 70	1.7 (1.4 to 2.0)	1.6 (1.3 to 1.9)	1.3 (1.1 to 1.5)	1.5 (1.3 to 1.8)	1.7 (1.4 to 2.0)	1.4 (1.2 to 1.6)	1.6 (1.4 to 1.8)	1.4 (1.2 to 1.6)	1.3 (1.1 to 1.5)	1.5 (1.3 to 1.8)	1.4 (1.2 to 1.7)	1.5 (1.3 to 1.8)	1.6 (1.3 to 1.9)
Day 84	1.7 (1.4 to 2.1)	1.7 (1.4 to 2.0)	1.5 (1.2 to 1.9)	1.4 (1.2 to 1.7)	1.8 (1.4 to 2.2)	1.6 (1.3 to 1.9)	1.9 (1.7 to 2.2)	1.3 (1.1 to 1.5)	1.3 (1.0 to 1.6)	1.5 (1.3 to 1.8)	1.6 (1.3 to 1.9)	1.6 (1.3 to 1.8)	1.7 (1.4 to 2.1)
Day 182	1.6 (1.3 to 1.9)	1.5 (1.2 to 1.7)	1.3 (1.1 to 1.6)	1.3 (1.0 to 1.5)	1.5 (1.2 to 1.8)	1.3 (1.1 to 1.5)	1.6 (1.4 to 1.8)	1.3 (1.1 to 1.5)	1.3 (1.1 to 1.6)	1.3 (1.1 to 1.5)	1.3 (1.1 to 1.5)	1.3 (1.1 to 1.6)	1.5 (1.2 to 1.8)

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre)

Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.

Time frame:: Day 28 to Day 182
Reported as:: Geometric mean · geometric mean fold rise

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre)
geometric mean fold rise	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 28	2.0 (1.6 to 2.3)	1.6 (1.3 to 2.0)	1.4 (1.1 to 1.7)	1.4 (1.2 to 1.8)	1.9 (1.4 to 2.5)	1.4 (1.1 to 1.7)	1.9 (1.6 to 2.2)	1.6 (1.3 to 1.9)	1.3 (1.1 to 1.5)	1.6 (1.3 to 2.0)	1.7 (1.4 to 2.0)	1.9 (1.6 to 2.4)	2.7 (2.0 to 3.6)
Day 56	1.8 (1.5 to 2.1)	1.5 (1.2 to 1.8)	1.5 (1.2 to 1.8)	1.3 (1.1 to 1.6)	1.6 (1.2 to 2.1)	1.3 (1.1 to 1.6)	1.7 (1.5 to 1.9)	1.5 (1.3 to 1.8)	1.2 (1.0 to 1.4)	1.5 (1.3 to 1.9)	1.5 (1.3 to 1.8)	1.8 (1.5 to 2.2)	2.3 (1.8 to 3.0)
Day 70	2.3 (1.9 to 2.7)	2.0 (1.6 to 2.4)	1.9 (1.5 to 2.3)	1.8 (1.5 to 2.3)	2.3 (1.8 to 3.1)	1.7 (1.4 to 2.0)	2.1 (1.8 to 2.4)	1.8 (1.5 to 2.2)	1.5 (1.3 to 1.7)	2.0 (1.6 to 2.5)	1.9 (1.6 to 2.3)	2.1 (1.7 to 2.5)	2.3 (1.7 to 3.0)
Day 84	2.2 (1.8 to 2.6)	2.0 (1.6 to 2.4)	2.1 (1.8 to 2.6)	1.8 (1.4 to 2.3)	2.5 (1.9 to 3.2)	1.8 (1.4 to 2.2)	2.3 (2.0 to 2.7)	1.7 (1.4 to 2.1)	1.6 (1.3 to 1.9)	2.2 (1.8 to 2.6)	2.2 (1.8 to 2.7)	2.2 (1.8 to 2.6)	2.4 (1.8 to 3.1)
Day 182	2.0 (1.6 to 2.4)	1.7 (1.4 to 2.0)	1.8 (1.5 to 2.2)	1.6 (1.2 to 2.0)	2.0 (1.5 to 2.5)	1.5 (1.2 to 1.9)	1.8 (1.6 to 2.1)	1.5 (1.2 to 1.9)	1.5 (1.3 to 1.7)	1.7 (1.5 to 2.0)	1.6 (1.4 to 1.9)	1.8 (1.5 to 2.3)	1.8 (1.4 to 2.3)

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre)

Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.

Time frame:: Day 28 to Day 182
Reported as:: Geometric mean · geometric mean fold rise

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre)
geometric mean fold rise	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 28	1.3 (1.2 to 1.5)	1.2 (1.1 to 1.4)	1.1 (1.0 to 1.2)	1.2 (1.0 to 1.4)	1.3 (1.1 to 1.6)	1.2 (1.0 to 1.4)	1.3 (1.1 to 1.4)	1.1 (1.0 to 1.3)	1.1 (1.0 to 1.3)	1.2 (1.1 to 1.4)	1.2 (1.0 to 1.4)	1.2 (1.1 to 1.4)	1.5 (1.2 to 2.0)
Day 56	1.2 (1.1 to 1.4)	1.2 (1.1 to 1.4)	1.0 (0.9 to 1.1)	1.2 (1.0 to 1.4)	1.1 (1.0 to 1.3)	1.1 (0.9 to 1.2)	1.2 (1.1 to 1.3)	1.1 (1.0 to 1.2)	1.1 (1.0 to 1.2)	1.1 (1.0 to 1.3)	1.1 (0.9 to 1.3)	1.2 (1.1 to 1.3)	1.4 (1.1 to 1.8)
Day 70	1.4 (1.3 to 1.6)	1.3 (1.2 to 1.5)	1.2 (1.0 to 1.4)	1.3 (1.1 to 1.6)	1.4 (1.1 to 1.6)	1.2 (1.0 to 1.4)	1.3 (1.2 to 1.5)	1.2 (1.1 to 1.3)	1.2 (1.0 to 1.3)	1.4 (1.2 to 1.6)	1.2 (1.0 to 1.5)	1.2 (1.1 to 1.4)	1.5 (1.2 to 1.9)
Day 84	0.9 (0.8 to 1.0)	0.9 (0.8 to 1.0)	0.8 (0.7 to 0.9)	0.8 (0.7 to 1.0)	0.9 (0.8 to 1.1)	0.7 (0.6 to 0.9)	0.9 (0.8 to 1.1)	0.8 (0.6 to 0.9)	0.7 (0.6 to 0.9)	0.9 (0.7 to 1.0)	0.9 (0.7 to 1.1)	0.8 (0.7 to 1.0)	1.0 (0.8 to 1.3)
Day 182	0.8 (0.7 to 0.9)	0.8 (0.7 to 0.9)	0.7 (0.6 to 0.8)	0.7 (0.6 to 0.9)	0.7 (0.6 to 0.9)	0.7 (0.5 to 0.8)	0.8 (0.7 to 0.9)	0.7 (0.6 to 0.9)	0.7 (0.6 to 0.9)	0.8 (0.7 to 1.0)	0.7 (0.6 to 0.8)	0.8 (0.7 to 0.9)	0.9 (0.7 to 1.2)

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR)

Hemagglutination-Inhibition (HAI) Antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.

Time frame:: Day 28 to Day 182
Reported as:: Number · percentage of participants

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR)
percentage of participants	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 28	15.2 (8.1 to 25.0)	10.0 (2.8 to 23.7)	5.3 (0.6 to 17.7)	2.7 (0.1 to 14.2)	12.2 (4.1 to 26.2)	5.0 (0.6 to 16.9)	14.1 (7.3 to 23.8)	5.1 (0.6 to 17.3)	0 (0.0 to 9.0)	12.8 (4.3 to 27.4)	7.7 (1.6 to 20.9)	4.9 (0.6 to 16.5)	15.4 (5.9 to 30.5)
Day 56	12.8 (6.3 to 22.3)	7.7 (1.6 to 20.9)	8.3 (1.8 to 22.5)	0 (0.0 to 9.7)	5.0 (0.6 to 16.9)	5.0 (0.6 to 16.9)	10.1 (4.5 to 19.0)	5.1 (0.6 to 17.3)	0 (0.0 to 9.3)	8.1 (1.7 to 21.9)	5.3 (0.6 to 17.7)	5.0 (0.6 to 16.9)	10.3 (2.9 to 24.2)
Day 70	17.1 (9.4 to 27.5)	15.4 (5.9 to 30.5)	17.1 (6.6 to 33.6)	11.1 (3.1 to 26.1)	10.0 (2.8 to 23.7)	7.5 (1.6 to 20.4)	15.8 (8.4 to 26.0)	10.5 (2.9 to 24.8)	5.3 (0.6 to 17.7)	13.9 (4.7 to 29.5)	13.5 (4.5 to 28.8)	17.1 (7.2 to 32.1)	10.5 (2.9 to 24.8)
Day 84	14.5 (7.5 to 24.4)	20.5 (9.3 to 36.5)	11.8 (3.3 to 27.5)	0 (0.0 to 10.0)	7.7 (1.6 to 20.9)	2.6 (0.1 to 13.8)	14.5 (7.5 to 24.4)	2.6 (0.1 to 13.8)	5.3 (0.6 to 17.7)	5.9 (0.7 to 19.7)	10.8 (3.0 to 25.4)	7.3 (1.5 to 19.9)	7.9 (1.7 to 21.4)
Day 182	10.8 (0.1 to 13.8)	10.3 (2.9 to 24.2)	2.9 (0.1 to 15.3)	0 (0.0 to 10.0)	2.6 (0.1 to 13.5)	0 (0.0 to 9.3)	6.7 (2.2 to 14.9)	2.7 (0.1 to 14.2)	0 (0.0 to 9.5)	0 (0.0 to 9.7)	5.3 (0.6 to 17.7)	2.6 (0.1 to 13.5)	2.6 (0.1 to 13.8)

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR

Hemagglutination-Inhibition (HAI) Antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.

Time frame:: Day 28 to Day 182
Reported as:: Number · percentage of participants

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR
percentage of participants	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 28	63.3 (51.7 to 73.9)	45.0 (29.3 to 61.5)	42.1 (26.3 to 59.2)	37.8 (22.5 to 55.2)	51.2 (35.1 to 67.1)	37.5 (22.7 to 54.2)	56.4 (44.7 to 67.6)	33.3 (19.1 to 50.2)	28.2 (15.0 to 44.9)	51.3 (34.8 to 67.6)	61.5 (44.6 to 76.6)	51.2 (35.1 to 67.1)	69.2 (52.4 to 83.0)
Day 56	60.3 (48.5 to 71.2)	38.5 (23.4 to 55.4)	41.7 (25.5 to 59.2)	27.8 (14.2 to 45.2)	37.5 (22.7 to 54.2)	30.0 (16.6 to 46.5)	51.9 (40.4 to 63.3)	25.6 (13.0 to 42.1)	26.3 (13.4 to 43.1)	45.9 (29.5 to 63.1)	44.7 (28.6 to 61.7)	45.0 (29.3 to 61.5)	61.5 (44.6 to 76.6)
Day 70	71.1 (59.5 to 80.9)	53.8 (37.2 to 69.9)	54.3 (36.6 to 71.2)	61.1 (43.5 to 76.9)	67.5 (50.9 to 81.4)	47.5 (31.5 to 63.9)	65.8 (54.0 to 76.3)	52.6 (35.8 to 69.0)	39.5 (24.0 to 56.6)	55.6 (38.1 to 72.1)	64.9 (47.5 to 79.8)	56.1 (39.7 to 71.5)	57.9 (40.8 to 73.7)
Day 84	67.5 (55.9 to 77.8)	46.2 (30.1 to 62.8)	52.9 (35.1 to 70.2)	42.9 (26.3 to 60.6)	53.8 (37.2 to 69.9)	42.1 (26.3 to 59.2)	65.8 (54.0 to 76.3)	39.5 (24.0 to 56.6)	36.8 (21.8 to 54.0)	58.8 (40.7 to 75.4)	54.1 (36.9 to 70.5)	51.2 (35.1 to 67.1)	52.6 (35.8 to 69.0)
Day 182	39.2 (28.0 to 51.2)	33.3 (19.1 to 50.2)	41.2 (24.6 to 59.3)	20.0 (8.4 to 36.9)	38.5 (23.4 to 55.4)	28.9 (15.4 to 45.9)	46.7 (35.1 to 58.7)	21.6 (9.8 to 38.2)	21.6 (9.8 to 38.2)	38.9 (23.1 to 56.5)	28.9 (15.4 to 45.9)	43.6 (27.8 to 60.4)	34.2 (19.6 to 51.4)

SecondaryHemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR

Hemagglutination-Inhibition (HAI) Antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.

Time frame:: Day 28 to Day 182
Reported as:: Number · percentage of participants

Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR
percentage of participants	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 28	10.1 (4.5 to 19.0)	5.0 (0.6 to 16.9)	2.6 (0.1 to 13.8)	0 (0.0 to 9.5)	4.9 (0.6 to 16.5)	2.6 (0.1 to 13.5)	9.0 (3.7 to 17.6)	2.6 (0.1 to 13.5)	0 (0.0 to 9.0)	5.1 (0.6 to 17.3)	2.6 (0.1 to 13.5)	2.4 (0.1 to 12.9)	5.1 (0.6 to 17.3)
Day 56	6.4 (2.1 to 14.3)	5.1 (0.6 to 17.3)	0 (0.0 to 9.7)	0 (0.0 to 9.7)	2.5 (0.1 to 13.2)	0 (0.0 to 8.8)	5.1 (1.4 to 12.5)	2.6 (0.1 to 13.5)	0 (0.0 to 9.3)	2.7 (0.1 to 14.2)	2.6 (0.1 to 13.8)	0 (0.0 to 8.8)	5.1 (0.6 to 17.3)
Day 70	9.2 (3.8 to 18.1)	7.7 (1.6 to 20.9)	0 (0.0 to 10.0)	0 (0.0 to 9.7)	7.5 (1.6 to 20.4)	0 (0.0 to 8.8)	6.6 (2.2 to 14.7)	5.3 (0.6 to 17.7)	0 (0.0 to 9.3)	5.6 (0.7 to 18.7)	2.7 (0.1 to 14.2)	2.4 (0.1 to 12.9)	5.3 (0.6 to 17.7)
Day 84	3.9 (0.8 to 11.0)	5.1 (0.6 to 17.3)	0 (0.0 to 10.3)	0 (0.0 to 10.0)	2.6 (0.1 to 13.5)	2.6 (0.1 to 13.8)	2.6 (0.3 to 9.2)	2.6 (0.1 to 13.8)	0 (0.0 to 9.3)	2.9 (0.1 to 15.3)	0 (0.0 to 9.5)	0 (0.0 to 8.6)	2.6 (0.1 to 13.8)
Day 182	2.7 (0.3 to 9.4)	2.6 (0.1 to 13.5)	0 (0.0 to 10.3)	0 (0.0 to 10.0)	2.6 (0.1 to 13.5)	2.6 (0.1 to 13.8)	2.7 (0.3 to 9.3)	0 (0.0 to 9.5)	0 (0.0 to 9.5)	2.8 (0.1 to 14.5)	0 (0.0 to 9.3)	0 (0.0 to 9.0)	2.6 (0.1 to 13.8)

SecondaryHAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR

HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.

Time frame:: Day 28 to Day 182
Reported as:: Number · percentage of participants

HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR
percentage of participants	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 28	30.4 (20.5 to 41.8)	22.5 (10.8 to 38.5)	23.7 (11.4 to 40.2)	13.5 (4.5 to 28.8)	26.8 (14.2 to 42.9)	20.0 (9.1 to 35.6)	28.2 (18.6 to 39.5)	12.8 (4.3 to 27.4)	15.4 (5.9 to 30.5)	41.0 (25.6 to 57.9)	30.8 (17.0 to 47.6)	19.5 (8.8 to 34.9)	30.8 (17.0 to 47.6)
Day 56	23.1 (14.3 to 34.0)	17.9 (7.5 to 33.5)	19.4 (8.2 to 36.0)	11.1 (3.1 to 26.1)	15.0 (5.7 to 29.8)	12.5 (4.2 to 26.8)	20.3 (12.0 to 30.8)	10.3 (2.9 to 24.2)	13.2 (4.4 to 28.1)	35.1 (20.2 to 52.5)	26.3 (13.4 to 43.1)	15.0 (5.7 to 29.8)	23.1 (11.1 to 39.3)
Day 70	27.6 (18.0 to 39.1)	30.8 (17.0 to 47.6)	25.7 (12.5 to 43.3)	13.9 (4.7 to 29.5)	25.0 (12.7 to 41.2)	22.5 (10.8 to 38.5)	28.9 (19.1 to 40.5)	18.4 (7.7 to 34.3)	15.8 (6.0 to 31.3)	36.1 (20.8 to 53.8)	27.0 (13.8 to 44.1)	17.1 (7.2 to 32.1)	21.1 (9.6 to 37.3)
Day 84	14.3 (7.4 to 24.1)	15.4 (5.9 to 30.5)	8.8 (1.9 to 23.7)	5.7 (0.7 to 19.2)	12.8 (4.3 to 27.4)	13.2 (4.4 to 28.1)	15.8 (8.4 to 26.0)	13.2 (4.4 to 28.1)	10.5 (2.9 to 24.8)	23.5 (10.7 to 41.2)	13.5 (4.5 to 28.8)	12.2 (4.1 to 26.2)	10.5 (2.9 to 24.8)
Day 182	10.8 (4.8 to 20.2)	17.9 (7.5 to 33.5)	8.8 (1.9 to 23.7)	5.7 (0.7 to 19.2)	5.1 (0.6 to 17.3)	10.5 (2.9 to 24.8)	9.3 (3.8 to 18.3)	5.4 (0.7 to 18.2)	8.1 (1.7 to 21.9)	11.1 (3.1 to 26.1)	5.3 (0.6 to 17.7)	5.1 (0.6 to 17.3)	7.9 (1.7 to 21.4)

SecondaryHAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR

HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype)strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.

Time frame:: Day 28 to Day 182
Reported as:: Number · percentage of participants

HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR
percentage of participants	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 28	21.5 (13.1 to 32.2)	22.5 (10.8 to 38.5)	13.2 (4.4 to 28.1)	10.8 (3.0 to 25.4)	17.1 (7.2 to 32.1)	5.0 (0.6 to 16.9)	25.6 (16.4 to 36.8)	7.7 (1.6 to 20.9)	17.9 (7.5 to 33.5)	28.2 (15.0 to 44.9)	25.6 (13.0 to 42.1)	17.1 (7.2 to 32.1)	20.5 (9.3 to 36.5)
Day 56	19.2 (11.2 to 29.7)	20.5 (9.3 to 36.5)	13.9 (4.7 to 29.5)	8.3 (1.8 to 22.5)	10.0 (2.8 to 23.7)	7.5 (1.6 to 20.4)	19.0 (11.0 to 29.4)	7.7 (1.6 to 20.9)	10.5 (2.9 to 24.8)	18.9 (8.0 to 35.2)	10.5 (2.9 to 24.8)	12.5 (4.2 to 26.8)	15.4 (5.9 to 30.5)
Day 70	25.0 (15.8 to 36.3)	23.1 (11.1 to 39.3)	17.1 (6.6 to 33.6)	11.1 (3.1 to 26.1)	12.5 (4.2 to 26.8)	12.5 (4.2 to 26.8)	21.1 (12.5 to 31.9)	13.2 (4.4 to 28.1)	18.4 (7.7 to 34.3)	27.8 (14.2 to 45.2)	18.9 (8.0 to 35.2)	12.2 (4.1 to 26.2)	13.2 (4.4 to 28.1)
Day 84	11.7 (5.5 to 21.0)	15.4 (5.9 to 30.5)	11.8 (3.3 to 27.5)	5.7 (0.7 to 19.2)	10.3 (2.9 to 24.2)	5.3 (0.6 to 17.7)	15.8 (8.4 to 26.0)	5.3 (0.6 to 17.7)	10.5 (2.9 to 24.8)	20.6 (8.7 to 37.9)	13.5 (4.5 to 28.8)	9.8 (2.7 to 23.1)	13.2 (4.4 to 28.1)
Day 182	6.8 (2.2 to 15.1)	12.8 (4.3 to 27.4)	5.9 (0.7 to 19.7)	5.7 (0.7 to 19.2)	5.1 (0.6 to 17.3)	5.3 (0.6 to 17.7)	9.3 (3.8 to 18.3)	0 (0.0 to 9.5)	0 (0.0 to 9.5)	8.3 (1.8 to 22.5)	2.6 (0.1 to 13.8)	7.7 (1.6 to 20.9)	10.5 (2.9 to 24.8)

SecondaryHAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR

HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.

Time frame:: Day 28 to Day 182
Reported as:: Number · percentage of participants

HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR
percentage of participants	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 28	11.4 (5.3 to 20.5)	17.5 (7.3 to 32.8)	5.3 (0.6 to 17.7)	5.4 (0.7 to 18.2)	4.9 (0.6 to 16.5)	5.0 (0.6 to 16.9)	14.1 (7.3 to 23.8)	0 (0.0 to 9.0)	5.1 (0.6 to 17.3)	10.3 (2.9 to 24.2)	7.7 (1.6 to 20.9)	4.9 (0.6 to 16.5)	20.5 (9.3 to 36.5)
Day 56	12.8 (6.3 to 22.3)	7.7 (1.6 to 20.9)	0 (0.0 to 9.7)	2.8 (0.1 to 14.5)	2.5 (0.1 to 13.2)	5.0 (0.6 to 16.9)	10.1 (4.5 to 19.0)	0 (0.0 to 9.0)	2.6 (0.1 to 13.8)	5.4 (0.7 to 18.2)	5.3 (0.6 to 17.7)	0 (0.0 to 8.8)	15.4 (5.9 to 30.5)
Day 70	15.8 (8.4 to 26.0)	12.8 (4.3 to 27.4)	2.9 (0.1 to 14.9)	8.3 (1.8 to 22.5)	10.0 (2.8 to 23.7)	7.5 (1.6 to 20.4)	14.5 (7.5 to 24.4)	2.6 (0.1 to 13.8)	7.9 (1.7 to 21.4)	8.3 (1.8 to 22.5)	5.4 (0.7 to 18.2)	7.3 (1.5 to 19.9)	10.5 (2.9 to 24.8)
Day 84	22.1 (13.4 to 33.0)	12.8 (4.3 to 27.4)	11.8 (3.3 to 27.5)	8.6 (1.8 to 23.1)	17.9 (7.5 to 33.5)	7.9 (1.7 to 21.4)	19.7 (11.5 to 30.5)	2.6 (0.1 to 13.8)	10.5 (2.9 to 24.8)	11.8 (3.3 to 27.5)	8.1 (1.7 to 21.9)	4.9 (0.6 to 16.5)	13.2 (4.4 to 28.1)
Day 182	16.2 (8.7 to 26.6)	10.3 (2.9 to 24.2)	5.9 (0.7 to 19.7)	8.6 (1.8 to 23.1)	7.7 (1.6 to 20.9)	2.6 (0.1 to 13.8)	16.0 (8.6 to 26.3)	0 (0.0 to 9.5)	5.4 (0.7 to 18.2)	0 (0.0 to 9.7)	2.6 (0.1 to 13.8)	2.6 (0.1 to 13.5)	13.2 (4.4 to 28.1)

SecondaryHAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR

HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.

Time frame:: Day 28 to Day 182
Reported as:: Number · percentage of participants

HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR
percentage of participants	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 28	20.3 (12.0 to 30.8)	22.5 (10.8 to 38.5)	2.6 (0.1 to 13.8)	5.4 (0.7 to 18.2)	22.0 (10.6 to 37.6)	10.0 (2.8 to 23.7)	17.9 (10.2 to 28.3)	10.3 (2.9 to 24.2)	10.3 (2.9 to 24.2)	12.8 (4.3 to 27.4)	15.4 (5.9 to 30.5)	22.0 (10.6 to 37.6)	43.6 (27.8 to 60.4)
Day 56	16.7 (9.2 to 26.8)	15.4 (5.9 to 30.5)	5.6 (0.7 to 18.7)	5.6 (0.7 to 18.7)	10.0 (2.8 to 23.7)	7.5 (1.6 to 20.4)	11.4 (5.3 to 20.5)	7.7 (1.6 to 20.9)	2.6 (0.1 to 13.8)	8.1 (1.7 to 21.9)	10.5 (2.9 to 24.8)	17.5 (7.3 to 32.8)	38.5 (23.4 to 55.4)
Day 70	25.0 (15.8 to 36.3)	25.6 (13.0 to 42.1)	17.1 (6.6 to 33.6)	11.1 (3.1 to 26.1)	37.5 (22.7 to 54.2)	10.0 (2.8 to 23.7)	21.1 (12.5 to 31.9)	7.9 (1.7 to 21.4)	7.9 (1.7 to 21.4)	22.2 (10.1 to 39.2)	13.5 (4.5 to 28.8)	24.4 (12.4 to 40.3)	34.2 (19.6 to 51.4)
Day 84	29.9 (20.0 to 41.4)	30.8 (17.0 to 47.6)	17.6 (6.8 to 34.5)	20.0 (8.4 to 36.9)	33.3 (19.1 to 50.2)	13.2 (4.4 to 28.1)	34.2 (23.7 to 46.0)	18.4 (7.7 to 34.3)	7.9 (1.7 to 21.4)	26.5 (12.9 to 44.4)	27.0 (13.8 to 44.1)	22.0 (10.6 to 37.6)	42.1 (26.3 to 59.2)
Day 182	20.3 (11.8 to 31.2)	17.9 (7.5 to 33.5)	11.8 (3.3 to 27.5)	11.4 (3.2 to 26.7)	17.9 (7.5 to 33.5)	10.5 (2.9 to 24.8)	18.7 (10.6 to 29.3)	16.2 (6.2 to 32.0)	5.4 (0.7 to 18.2)	11.1 (3.1 to 26.1)	7.9 (1.7 to 21.4)	12.8 (4.3 to 27.4)	21.1 (9.6 to 37.3)

SecondaryHAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR

HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.

Time frame:: Day 28 to Day 182
Reported as:: Number · percentage of participants

HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR
percentage of participants	Group A and Group C - ICC Vaccine Formulation	Group B -ICC Vaccine Formulation	Group D - ICC Vaccine Formulation	Group E - ICC Vaccine Formulation	Group F- ICC Vaccine Formulation	Group G- ICC Vaccine Formulation	Group H and Group N- ICC Vaccine Formulation	Group I- ICC Vaccine Formulation	Group J -ICC Vaccine Formulation	Group K - ICC Vaccine Formulation	Group L - ICC Vaccine Formulation	Group M -ICC Vaccine Formulation	Group O - qNIV With Matrix-M1 Adjuvant
Day 28	5.1 (1.4 to 12.5)	0 (0.0 to 8.8)	0 (0.0 to 9.3)	2.7 (0.1 to 14.2)	4.9 (0.6 to 16.5)	5.0 (0.6 to 16.9)	6.4 (2.1 to 14.3)	2.6 (0.1 to 13.5)	2.6 (0.1 to 13.5)	2.6 (0.1 to 13.5)	7.7 (1.6 to 20.9)	4.9 (0.6 to 16.5)	15.4 (5.9 to 30.5)
Day 56	6.4 (2.1 to 14.3)	0 (0.0 to 9.0)	0 (0.0 to 9.7)	2.8 (0.1 to 14.5)	2.5 (0.1 to 13.2)	2.5 (0.1 to 13.2)	3.8 (0.8 to 10.7)	0 (0.0 to 9.0)	2.6 (0.1 to 13.8)	3.8 (0.1 to 14.2)	2.6 (0.1 to 13.8)	0 (0.0 to 8.8)	15.4 (5.9 to 30.5)
Day 70	6.6 (2.2 to 14.7)	0 (0.0 to 9.0)	0 (0.0 to 10.0)	2.8 (0.1 to 14.5)	7.5 (1.6 to 20.4)	5.0 (0.6 to 16.9)	5.3 (1.5 to 12.9)	0 (0.0 to 9.3)	0 (0.0 to 9.3)	2.8 (0.1 to 14.5)	8.1 (1.7 to 21.9)	0 (0.0 to 8.6)	13.2 (4.4 to 28.1)
Day 84	1.3 (0.0 to 7.0)	0 (0.0 to 9.0)	0 (0.0 to 10.3)	2.9 (0.1 to 14.9)	2.6 (0.1 to 13.5)	0 (0.0 to 9.3)	1.3 (0.0 to 7.1)	0 (0.0 to 9.3)	2.6 (0.1 to 13.8)	0 (0.0 to 10.3)	2.7 (0.1 to 14.2)	0 (0.0 to 8.6)	7.9 (1.7 to 21.4)
Day 182	2.7 (0.3 to 9.4)	0 (0.0 to 9.0)	0 (0.0 to 10.3)	2.9 (0.1 to 14.9)	2.6 (0.1 to 13.5)	0 (0.0 to 9.3)	0 (0.0 to 4.8)	0 (0.0 to 9.5)	2.7 (0.1 to 14.2)	0 (0.0 to 9.7)	2.6 (0.1 to 13.8)	0 (0.0 to 9.0)	5.3 (0.6 to 17.7)

SecondaryHAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR)