Influenza, Human
Conditions
Keywords
Grippe, Human Flu, Human influenza
Brief summary
This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of participants to receive seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or placebo (phosphate buffered saline). A total of 60 healthy male and female adults 18 through 45 years of age will be randomized to receive vaccine (30) or placebo (30).
Detailed description
This is a phase 1, double blinded, randomized, placebo-controlled study. The study will be conducted at 1 site in Serbia. Sixty (60) healthy male and female adults, 18 to 45 years of age, will be enrolled into the trial. Subjects will be randomized 1:1 to one of two treatment allocations: 30 to vaccine, 30 to placebo. The study will utilize a randomized block design to assure a balance of 1:1 vaccine and placebo when all subjects are enrolled. The study will be double blinded, meaning the study subjects, investigators, and the sponsor will be unaware of the treatment allocated to each subject until the clinical trial database is declared final and locked. The study should take about 5 months to complete, with each subject involved for 3 months from the day of injection. The justification for the 3 month follow up, rather than 6 month follow up is that this is an inactivated vaccine that follows very standard manufacturing practices with standard antigens. The safety of inactivated influenza vaccines is well-established. Adding length to the follow up results in delays in future testing of the vaccine for licensure.
Interventions
BIOLOGICALInfluenza vaccine, split inactivated
Seasonal trivalent inactivated influenza vaccine (TIV), inactivated split virion, purified by sucrose gradient ultracentrifugation. The vaccine is produced in hen's eggs, and inactivated with beta-propiolactone.
OTHERPlacebo
0.5 mL of phosphate buffered saline
Sponsors
Department of Health and Human Services
World Health Organization
PATH
Comac Medical
Institute of Virology, Vaccines and Sera, Torlak
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female adult 18 through 45 years of age at the enrollment visit. * Literate (by self-report) and willing to provide written informed consent. * Healthy, as established by the medical history, physical examination, and screening laboratory evaluations. * Capable and willing to complete Memory Aids and willing to return for all follow-up visits. * For females, willing to utilize reliable birth control measures (e.g., intrauterine device, hormonal contraception, condoms) from Day 0 through the Day 21 visit.
Exclusion criteria
* Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study. * Receipt of any non-study vaccine within 4 weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 21 visit. * Current or recent (within 2 weeks of vaccination) acute illness with or without fever. * Receipt of immune globulin or other blood products within 3 months prior to study enrollment or planned receipt of such products prior to the Day 21 visit. * Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study vaccination. (For corticosteroids, this means prednisone or equivalent, equal or more than 0.5 mg per kg per day; topical steroids are allowed.) * History of asthma. * Hypersensitivity after previous administration of any vaccine. * Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein. * Acute or chronic clinically significant pulmonary, cardiovascular, hepatobiliary, metabolic, neurologic, psychiatric or renal functional abnormality, as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives. * History of any blood or solid organ cancer. * History of thrombocytopenic purpura or known bleeding disorder. * History of seizures. * Known or suspected immunosuppressed or immunodeficient condition of any kind. * Confirmed hepatitis B virus (HBV) or hepatitis C virus (HCV) infection * Known HIV infection (self-report). * Known active tuberculosis or symptoms of active tuberculosis, regardless of cause (self-report). * History of chronic alcohol abuse and/or illegal drug use. * Pregnancy or lactation. (A negative pregnancy test will be required before administration of study product for all women of childbearing potential.) * History of Guillain-Barré Syndrome * Any condition that, in the opinion of the investigator, would increase the health risk to the subject if he/she participates in the study or would interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Immediate Adverse Events | 30-minute post-vaccination period. | Number of subjects with observed immediate adverse events, including allergic reaction or anaphylaxis, following administration of the study product. |
| Number and Percentage of Subjects With Solicited Local Reactogenicity | 7-day period (Days 0-6) post-vaccination. | Number of subjects reporting solicited local reactions (redness, swelling, induration, pain and tenderness) at the injection site post-vaccination with study vaccine or placebo |
| Number and Percentage of Subjects With Solicited Systemic Reactogenicity | 7-day period (Days 0-6) post-vaccination. | Number of subjects reporting solicited systemic reactions (fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache) post-vaccination with study vaccine or Placebo |
| Number and Percentage of Subjects With Occurrence of Unsolicited Adverse Events | Within 21 days post vaccination | These data are presented broadly as number per group for the study. Please see AE reporting section for more specific details on AEs. |
| Number and Percentage of Subjects With Occurrence of Serious Adverse Events (SAE) | Over the entire study period (Day 90). | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Seroconverted Subjects Against 3 Strains of Influenza Vaccine. | Day 21 | Seroconversion is defined as a serum HAI titer meeting the following criteria: * pre-vaccination titer \<1:10 and a post-vaccination titer ≥ 1:40 or * pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination measured on Day 21. The 3 influenza strains assessed were B/Massachusetts, H1/A/California and H3/A/Texas |
| Geometric Mean Fold Rises (GMFRs) of MNT (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens. | Pre- (Day 0) and post-vaccination (Day 21) | The 3 influenza strains assessed were B/Massachusetts, H1/A/California an d H3/A/Texas |
| Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine | Day 0 and Day 21 post vaccination | A seroprotected subject was defined as a vaccinated subject who had a serum Hemagluttination Inhibition (HAI) titer ≥ 1:40. The 3 influenza strains assessed were B/Massachusetts, H1/A/California an d H3/A/Texas |
| Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens | Pre- (Day 0) and post-vaccination (Day 21) | The 3 influenza strains assessed were B/Massachusetts, H1/A/California an d H3/A/Texas |
| Geometric Mean Fold Rises (GMFRs) of Serum (HAI) Antibodies (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens. | Pre- (Day 0) and post-vaccination (Day 21) | The 3 influenza strains assessed were B/Massachusetts, H1/A/California an d H3/A/Texas |
| Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens. | Pre- (Day 0) and post-vaccination (Day 21) | — |
Countries
Serbia
Participant flow
Recruitment details
All volunteers were recruited at the Clinical Center of Serbia, Belgrade, Serbia.
Pre-assignment details
66 people were screened for the study after signing consent. 6 subjects failed screening. A total of 60 subjects received vaccine or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Vaccine Group 0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of B/Massachusetts, H1/A/California, and H3/A/Texas | 30 |
| Placebo Group 0.5 mL of phosphate buffered saline | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Vaccine Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 31.00 years STANDARD_DEVIATION 7.21 | 30.70 years STANDARD_DEVIATION 6.14 | 30.85 years STANDARD_DEVIATION 6.64 |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 30 Participants | 30 Participants | 60 Participants |
| Region of Enrollment Serbia | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 21 Participants | 21 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 2 / 30 | 4 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Number and Percentage of Subjects With Occurrence of Serious Adverse Events (SAE)
Time frame: Over the entire study period (Day 90).
Population: The analysis was conducted for subjects who were randomized and received a study vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine Group | Number and Percentage of Subjects With Occurrence of Serious Adverse Events (SAE) | Serious adverse events (SAEs)--related | 0 Participants |
| Vaccine Group | Number and Percentage of Subjects With Occurrence of Serious Adverse Events (SAE) | SAEs--not related | 0 Participants |
| Placebo Group | Number and Percentage of Subjects With Occurrence of Serious Adverse Events (SAE) | Serious adverse events (SAEs)--related | 0 Participants |
| Placebo Group | Number and Percentage of Subjects With Occurrence of Serious Adverse Events (SAE) | SAEs--not related | 0 Participants |
Primary
Number and Percentage of Subjects With Occurrence of Unsolicited Adverse Events
These data are presented broadly as number per group for the study. Please see AE reporting section for more specific details on AEs.
Time frame: Within 21 days post vaccination
Population: The analysis was conducted for subjects who were randomized and received a study vaccination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vaccine Group | Number and Percentage of Subjects With Occurrence of Unsolicited Adverse Events | 2 Participants |
| Placebo Group | Number and Percentage of Subjects With Occurrence of Unsolicited Adverse Events | 4 Participants |
Primary
Number and Percentage of Subjects With Solicited Local Reactogenicity
Number of subjects reporting solicited local reactions (redness, swelling, induration, pain and tenderness) at the injection site post-vaccination with study vaccine or placebo
Time frame: 7-day period (Days 0-6) post-vaccination.
Population: The analysis was conducted for subjects who were randomized and received a study vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine Group | Number and Percentage of Subjects With Solicited Local Reactogenicity | Pain | 14 Participants |
| Vaccine Group | Number and Percentage of Subjects With Solicited Local Reactogenicity | Swelling | 2 Participants |
| Vaccine Group | Number and Percentage of Subjects With Solicited Local Reactogenicity | Redness | 6 Participants |
| Vaccine Group | Number and Percentage of Subjects With Solicited Local Reactogenicity | Tenderness | 10 Participants |
| Vaccine Group | Number and Percentage of Subjects With Solicited Local Reactogenicity | Hardness | 2 Participants |
| Placebo Group | Number and Percentage of Subjects With Solicited Local Reactogenicity | Tenderness | 1 Participants |
| Placebo Group | Number and Percentage of Subjects With Solicited Local Reactogenicity | Hardness | 0 Participants |
| Placebo Group | Number and Percentage of Subjects With Solicited Local Reactogenicity | Pain | 4 Participants |
| Placebo Group | Number and Percentage of Subjects With Solicited Local Reactogenicity | Redness | 0 Participants |
| Placebo Group | Number and Percentage of Subjects With Solicited Local Reactogenicity | Swelling | 0 Participants |
Primary
Number and Percentage of Subjects With Solicited Systemic Reactogenicity
Number of subjects reporting solicited systemic reactions (fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache) post-vaccination with study vaccine or Placebo
Time frame: 7-day period (Days 0-6) post-vaccination.
Population: The analysis was conducted for subjects who were randomized and received a study vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine Group | Number and Percentage of Subjects With Solicited Systemic Reactogenicity | Temperature above 37 C | 2 Participants |
| Vaccine Group | Number and Percentage of Subjects With Solicited Systemic Reactogenicity | Chills | 2 Participants |
| Vaccine Group | Number and Percentage of Subjects With Solicited Systemic Reactogenicity | Headache | 5 Participants |
| Vaccine Group | Number and Percentage of Subjects With Solicited Systemic Reactogenicity | Joint aches | 1 Participants |
| Vaccine Group | Number and Percentage of Subjects With Solicited Systemic Reactogenicity | Muscle aches | 2 Participants |
| Vaccine Group | Number and Percentage of Subjects With Solicited Systemic Reactogenicity | Nausea | 2 Participants |
| Vaccine Group | Number and Percentage of Subjects With Solicited Systemic Reactogenicity | Tiredness | 5 Participants |
| Vaccine Group | Number and Percentage of Subjects With Solicited Systemic Reactogenicity | Vomiting | 1 Participants |
| Placebo Group | Number and Percentage of Subjects With Solicited Systemic Reactogenicity | Vomiting | 0 Participants |
| Placebo Group | Number and Percentage of Subjects With Solicited Systemic Reactogenicity | Temperature above 37 C | 1 Participants |
| Placebo Group | Number and Percentage of Subjects With Solicited Systemic Reactogenicity | Muscle aches | 1 Participants |
| Placebo Group | Number and Percentage of Subjects With Solicited Systemic Reactogenicity | Chills | 0 Participants |
| Placebo Group | Number and Percentage of Subjects With Solicited Systemic Reactogenicity | Tiredness | 0 Participants |
| Placebo Group | Number and Percentage of Subjects With Solicited Systemic Reactogenicity | Headache | 2 Participants |
| Placebo Group | Number and Percentage of Subjects With Solicited Systemic Reactogenicity | Nausea | 0 Participants |
| Placebo Group | Number and Percentage of Subjects With Solicited Systemic Reactogenicity | Joint aches | 2 Participants |
Primary
Number of Subjects With Immediate Adverse Events
Number of subjects with observed immediate adverse events, including allergic reaction or anaphylaxis, following administration of the study product.
Time frame: 30-minute post-vaccination period.
Population: The analysis was conducted for subjects who were randomized and received a study vaccination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vaccine Group | Number of Subjects With Immediate Adverse Events | 0 Participants |
| Placebo Group | Number of Subjects With Immediate Adverse Events | 0 Participants |
Secondary
Geometric Mean Fold Rises (GMFRs) of MNT (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens.
The 3 influenza strains assessed were B/Massachusetts, H1/A/California an d H3/A/Texas
Time frame: Pre- (Day 0) and post-vaccination (Day 21)
Population: All vaccinated subjects who have valid post vaccination immunogenicity measures with no major protocol violations
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Vaccine Group | Geometric Mean Fold Rises (GMFRs) of MNT (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens. | GMFR for H1 | 8.77 fold rise |
| Vaccine Group | Geometric Mean Fold Rises (GMFRs) of MNT (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens. | GMFR for H3 | 6.96 fold rise |
| Vaccine Group | Geometric Mean Fold Rises (GMFRs) of MNT (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens. | GMFR for B | 4.09 fold rise |
| Placebo Group | Geometric Mean Fold Rises (GMFRs) of MNT (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens. | GMFR for H1 | 1.26 fold rise |
| Placebo Group | Geometric Mean Fold Rises (GMFRs) of MNT (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens. | GMFR for H3 | 1.23 fold rise |
| Placebo Group | Geometric Mean Fold Rises (GMFRs) of MNT (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens. | GMFR for B | 1.50 fold rise |
Secondary
Geometric Mean Fold Rises (GMFRs) of Serum (HAI) Antibodies (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens.
The 3 influenza strains assessed were B/Massachusetts, H1/A/California an d H3/A/Texas
Time frame: Pre- (Day 0) and post-vaccination (Day 21)
Population: All vaccinated subjects who have valid post vaccination immunogenicity measures with no major protocol violations
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Vaccine Group | Geometric Mean Fold Rises (GMFRs) of Serum (HAI) Antibodies (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens. | GMFR for H1 | 18.49 fold rise |
| Vaccine Group | Geometric Mean Fold Rises (GMFRs) of Serum (HAI) Antibodies (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens. | GMFR for H3 | 11.65 fold rise |
| Vaccine Group | Geometric Mean Fold Rises (GMFRs) of Serum (HAI) Antibodies (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens. | GMFR for B | 7.25 fold rise |
| Placebo Group | Geometric Mean Fold Rises (GMFRs) of Serum (HAI) Antibodies (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens. | GMFR for H1 | 1.05 fold rise |
| Placebo Group | Geometric Mean Fold Rises (GMFRs) of Serum (HAI) Antibodies (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens. | GMFR for H3 | 1.04 fold rise |
| Placebo Group | Geometric Mean Fold Rises (GMFRs) of Serum (HAI) Antibodies (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens. | GMFR for B | 0.99 fold rise |
Secondary
Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens.
Time frame: Pre- (Day 0) and post-vaccination (Day 21)
Population: All vaccinated subjects who have valid post vaccination immunogenicity measures with no major protocol violations
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Vaccine Group | Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens. | GMT to H1 Day 0 | 24.06 Titers |
| Vaccine Group | Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens. | GMT to H1 Day 21 | 211.12 Titers |
| Vaccine Group | Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens. | GMT to H3 Day 0 | 18.02 Titers |
| Vaccine Group | Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens. | GMT to H3 Day 21 | 125.53 Titers |
| Vaccine Group | Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens. | GMT to B Day 0 | 80.93 Titers |
| Vaccine Group | Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens. | GMT to B Day 21 | 331.28 Titers |
| Placebo Group | Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens. | GMT to B Day 0 | 70.45 Titers |
| Placebo Group | Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens. | GMT to H1 Day 0 | 31.75 Titers |
| Placebo Group | Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens. | GMT to H3 Day 21 | 24.34 Titers |
| Placebo Group | Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens. | GMT to H1 Day 21 | 40.00 Titers |
| Placebo Group | Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens. | GMT to B Day 21 | 105.56 Titers |
| Placebo Group | Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens. | GMT to H3 Day 0 | 19.77 Titers |
Secondary
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens
The 3 influenza strains assessed were B/Massachusetts, H1/A/California an d H3/A/Texas
Time frame: Pre- (Day 0) and post-vaccination (Day 21)
Population: All vaccinated subjects with no major protocol violations who have valid post vaccination immunogenicity measures
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Vaccine Group | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens | GMT to H1 Day 0 | 15.97 Titers |
| Vaccine Group | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens | GMT to H1 Day 21 | 295.14 Titers |
| Vaccine Group | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens | GMT to H3 Day 0 | 37.75 Titers |
| Vaccine Group | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens | GMT to H3 Day 21 | 439.67 Titers |
| Vaccine Group | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens | GMT to B Day 0 | 10.47 Titers |
| Vaccine Group | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens | GMT to B Day 21 | 75.95 Titers |
| Placebo Group | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens | GMT to B Day 0 | 10.72 Titers |
| Placebo Group | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens | GMT to H1 Day 0 | 21.19 Titers |
| Placebo Group | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens | GMT to H3 Day 21 | 42.87 Titers |
| Placebo Group | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens | GMT to H1 Day 21 | 22.32 Titers |
| Placebo Group | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens | GMT to B Day 21 | 10.66 Titers |
| Placebo Group | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens | GMT to H3 Day 0 | 41.41 Titers |
Secondary
Number and Percentage of Seroconverted Subjects Against 3 Strains of Influenza Vaccine.
Seroconversion is defined as a serum HAI titer meeting the following criteria: * pre-vaccination titer \<1:10 and a post-vaccination titer ≥ 1:40 or * pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination measured on Day 21. The 3 influenza strains assessed were B/Massachusetts, H1/A/California and H3/A/Texas
Time frame: Day 21
Population: The analysis was conducted for subjects who were randomized and received a study vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine Group | Number and Percentage of Seroconverted Subjects Against 3 Strains of Influenza Vaccine. | Seroconversion to H1 | 25 Participants |
| Vaccine Group | Number and Percentage of Seroconverted Subjects Against 3 Strains of Influenza Vaccine. | Seroconversion to H3 | 23 Participants |
| Vaccine Group | Number and Percentage of Seroconverted Subjects Against 3 Strains of Influenza Vaccine. | Seroconversion to B | 21 Participants |
| Placebo Group | Number and Percentage of Seroconverted Subjects Against 3 Strains of Influenza Vaccine. | Seroconversion to H1 | 0 Participants |
| Placebo Group | Number and Percentage of Seroconverted Subjects Against 3 Strains of Influenza Vaccine. | Seroconversion to H3 | 0 Participants |
| Placebo Group | Number and Percentage of Seroconverted Subjects Against 3 Strains of Influenza Vaccine. | Seroconversion to B | 0 Participants |
Secondary
Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine
A seroprotected subject was defined as a vaccinated subject who had a serum Hemagluttination Inhibition (HAI) titer ≥ 1:40. The 3 influenza strains assessed were B/Massachusetts, H1/A/California an d H3/A/Texas
Time frame: Day 0 and Day 21 post vaccination
Population: All vaccinated subjects who have valid post vaccination immunogenicity measures with no major protocol violations
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine Group | Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine | H1 | 30 Participants |
| Vaccine Group | Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine | H3 | 30 Participants |
| Vaccine Group | Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine | B | 26 Participants |
| Placebo Group | Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine | H1 | 10 Participants |
| Placebo Group | Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine | H3 | 19 Participants |
| Placebo Group | Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine | B | 5 Participants |