Influenza
Conditions
Brief summary
The purpose of this study is to demonstrate the efficacy of an investigational Vero cell-derived, trivalent, seasonal influenza vaccine to prevent infection with an influenza virus that is antigenically similar to one of the three strains in the vaccine. Subjects will be randomized in a double-blind fashion to receive a single intramuscular injection of either the investigational vaccine or placebo. Blood will be drawn from all subjects for a determination of hemagglutination inhibition antibody titers on Days 0 and 21, body temperature and injection site reactions will be monitored daily for 7 days. In addition, subjects must return to the clinic promptly to have swab samples of their nose and throat taken whenever they feel flu symptoms and all subjects will be monitored for adverse events until Day 180.
Interventions
BIOLOGICALVero cell-derived, trivalent, seasonal influenza vaccine
Single intramuscular injection
BIOLOGICALPlacebo: Phosphate-buffered saline
Single intramuscular injection
Sponsors
Alachua Government Services, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject has an understanding of the study * Subject agrees to study provisions * Subject gives written informed consent prior to study entry * Subject is accessible by telephone or electronic mail to receive reminders from the study site * If female and capable of bearing children, subject has a negative urine pregnancy test result within 24 hours of the vaccination on Study Day 0 and agrees to employ adequate birth control measures through the first 60 post-vaccination days.
Exclusion criteria
* Subject has any of the risk factors for complications from influenza infection as defined by the Centers for Disease Control and Prevention (CDC, 2008a): * Pregnancy * Chronic disorders of the pulmonary or cardiovascular system including asthma (hypertension is not considered a high risk condition) * Chronic renal disorders * Chronic hepatic disorders * Chronic hematological disorders * Chronic metabolic disorder (including diabetes mellitus and thyroid disorders) * Immunosuppression (including immunosuppression caused by medications, congenital etiologies or HIV) * Any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase risk for aspiration (e.g., cognitive dysfunction, spinal cord injuries, seizure disorders or other neuromuscular disorders) * Residence in nursing home or other chronic care facility that houses persons of any age who have chronic medical conditions * Household contact with children aged 0 to 59 months or of someone who is included in the risk categories listed above * Employment as a health care worker * Subject is unable to lead an independent life as a result of either physical or mental handicap * Subject has a history of severe allergic reactions or anaphylaxis (e.g., urticaria or asthma that is clinically severe) * Subject has an oral temperature of \>= 99.5° F (37.5°C) on the day of vaccination in this study. \[NOTE: A subject meeting this exclusion criterion may be rescheduled for vaccination and study entry at a later date provided that certain requirements \[in the study protocol\] are met) * Subject has a rash or dermatologic condition or tattoos which may interfere with injection site reaction rating * Subject has received a blood transfusion, blood products or immunoglobulins within 90 days of study entry * Subject has received a live vaccine within 4 weeks or inactivated or subunit vaccine within 2 weeks of study entry * Subject has previously been vaccinated against influenza for the 2008/2009 northern hemisphere influenza season * Subject has a functional or surgical asplenia * Subject has a known or suspected problem with alcohol or drug abuse; * Subject was administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product * Subject is a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, spouse/partner, siblings, parents) as well as employees of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of an Investigational Vero Cell-derived Influenza Vaccine to Prevent Infection With an Influenza Virus That is Antigenically Similar to One of the Three Strains in the Vaccine | 180 days | The number of subjects developing influenza infection, as confirmed by viral culture and typing of naso-pharyngeal specimens, with a virus that is antigenically similar to one of the strains contained in the vaccine 21 days to 180 days after the date of vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Developed Influenza Infection Between 21 and 180 Days Post-vaccination, Regardless of Whether the Infecting Strain Matched the Vaccine Strains Antigenically | 180 days | Number of subjects with influenza infection as confirmed by viral culture and typing of naso-pharyngeal specimens regardless of whether the isolate is antigenically matched to the strains contained in the vaccine |
| HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 | 21 days | — |
| Percentage of Subjects With Seroprotective Antibody Titer [Reciprocal HIA Titer ≥ 40] for Each of the Three Antigens Contained in the Vaccine at Day 21 | 21 days | — |
| Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 as Compared to Baseline | 21 days | — |
| Number of Subjects Who Developed Influenza Infection 21 Days to 180 Days Post-vaccination With Infecting Strain Matching the Strains Contained in the Vaccine | 180 days | Number of subjects with influenza infection confirmed by viral culture and typing and/or RT-PCR analysis of naso-pharyngeal specimens that are antigenically similar to the strains contained in the vaccine |
| Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination | 180 days | Number of Subjects With Non-Serious Local Reactions During the Entire Follow-Up Period |
| Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period | 180 days | — |
| Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination | 180 days | Number of Subjects With Non-Serious Systemic Reactions During the Entire Follow-Up Period |
| Percentage of Subjects Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine at Day 21 | 21 days | Seroconversion is defined as a ≥ 4-fold increase in HIA titer from baseline or a HIA titer ≥ 40 when there is no detectable HIA titer (HIA titer \<10) at baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VCIV Vero cell-derived, trivalent, seasonal influenza vaccine
Vero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection | 3,623 |
| Placebo Phosphate-buffered saline
Placebo: Phosphate-buffered saline: Single intramuscular injection | 3,620 |
| Total | 7,243 |
Baseline characteristics
| Characteristic | VCIV | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 32.2 years STANDARD_DEVIATION 9.7 | 32.1 years STANDARD_DEVIATION 9.7 | 32.1 years STANDARD_DEVIATION 9.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 616 Participants | 638 Participants | 1254 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3007 Participants | 2982 Participants | 5989 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 171.6 cm STANDARD_DEVIATION 10 | 171.9 cm STANDARD_DEVIATION 10.2 | 171.7 cm STANDARD_DEVIATION 10.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 14 Participants | 25 Participants | 39 Participants |
| Race (NIH/OMB) Asian | 60 Participants | 37 Participants | 97 Participants |
| Race (NIH/OMB) Black or African American | 771 Participants | 741 Participants | 1512 Participants |
| Race (NIH/OMB) More than one race | 20 Participants | 21 Participants | 41 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 12 Participants | 10 Participants | 22 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 2746 Participants | 2784 Participants | 5530 Participants |
| Sex: Female, Male Female | 1800 Participants | 1755 Participants | 3555 Participants |
| Sex: Female, Male Male | 1823 Participants | 1865 Participants | 3688 Participants |
| Weight | 83.6 kg STANDARD_DEVIATION 22 | 83.3 kg STANDARD_DEVIATION 21.1 | 83.5 kg STANDARD_DEVIATION 21.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 3,623 | 0 / 3,620 |
| other Total, other adverse events | 2,176 / 3,623 | 1,945 / 3,620 |
| serious Total, serious adverse events | 29 / 3,623 | 27 / 3,620 |
Outcome results
Primary
Efficacy of an Investigational Vero Cell-derived Influenza Vaccine to Prevent Infection With an Influenza Virus That is Antigenically Similar to One of the Three Strains in the Vaccine
The number of subjects developing influenza infection, as confirmed by viral culture and typing of naso-pharyngeal specimens, with a virus that is antigenically similar to one of the strains contained in the vaccine 21 days to 180 days after the date of vaccination.
Time frame: 180 days
Population: Intent-to-Treat Analysis
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VCIV | Efficacy of an Investigational Vero Cell-derived Influenza Vaccine to Prevent Infection With an Influenza Virus That is Antigenically Similar to One of the Three Strains in the Vaccine | Influenza Infections A/H3N2 Strain | 2 Participants |
| VCIV | Efficacy of an Investigational Vero Cell-derived Influenza Vaccine to Prevent Infection With an Influenza Virus That is Antigenically Similar to One of the Three Strains in the Vaccine | Influenza Infections A/H1N1 Strain | 11 Participants |
| VCIV | Efficacy of an Investigational Vero Cell-derived Influenza Vaccine to Prevent Infection With an Influenza Virus That is Antigenically Similar to One of the Three Strains in the Vaccine | Influenza Infections B Strains | 0 Participants |
| VCIV | Efficacy of an Investigational Vero Cell-derived Influenza Vaccine to Prevent Infection With an Influenza Virus That is Antigenically Similar to One of the Three Strains in the Vaccine | No Influenza Infections | 3606 Participants |
| Placebo | Efficacy of an Investigational Vero Cell-derived Influenza Vaccine to Prevent Infection With an Influenza Virus That is Antigenically Similar to One of the Three Strains in the Vaccine | Influenza Infections A/H1N1 Strain | 52 Participants |
| Placebo | Efficacy of an Investigational Vero Cell-derived Influenza Vaccine to Prevent Infection With an Influenza Virus That is Antigenically Similar to One of the Three Strains in the Vaccine | Influenza Infections A/H3N2 Strain | 4 Participants |
| Placebo | Efficacy of an Investigational Vero Cell-derived Influenza Vaccine to Prevent Infection With an Influenza Virus That is Antigenically Similar to One of the Three Strains in the Vaccine | No Influenza Infections | 3557 Participants |
| Placebo | Efficacy of an Investigational Vero Cell-derived Influenza Vaccine to Prevent Infection With an Influenza Virus That is Antigenically Similar to One of the Three Strains in the Vaccine | Influenza Infections B Strains | 4 Participants |
Secondary
Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 as Compared to Baseline
Time frame: 21 days
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VCIV | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 as Compared to Baseline | A/H1N1 | 11.11 Fold change |
| VCIV | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 as Compared to Baseline | A/H3N2 | 13.51 Fold change |
| VCIV | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 as Compared to Baseline | B | 7.58 Fold change |
| Placebo | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 as Compared to Baseline | A/H1N1 | 1.06 Fold change |
| Placebo | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 as Compared to Baseline | A/H3N2 | 1.01 Fold change |
| Placebo | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 as Compared to Baseline | B | 1.03 Fold change |
Secondary
Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period
Time frame: 180 days
Population: Safety Analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VCIV | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period | Non-Serious Moderate or Severe Systemic AEs | 924 participants |
| VCIV | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period | Non-Serious Moderate or Severe Local AEs | 121 participants |
| VCIV | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period | Any Non-Serious Systemic AEs | 2176 participants |
| VCIV | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period | Any Non-Serious Local AEs | 1629 participants |
| VCIV | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period | Serious AEs | 29 participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period | Any Non-Serious Local AEs | 311 participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period | Serious AEs | 27 participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period | Non-Serious Moderate or Severe Systemic AEs | 858 participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period | Any Non-Serious Systemic AEs | 1945 participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period | Non-Serious Moderate or Severe Local AEs | 7 participants |
Secondary
Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination
Number of Subjects With Non-Serious Local Reactions During the Entire Follow-Up Period
Time frame: 180 days
Population: Safety Analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VCIV | Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination | Severe | 9 participants |
| VCIV | Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination | Total with Reaction | 1629 participants |
| VCIV | Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination | Moderate | 107 participants |
| VCIV | Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination | No Reaction | 1994 participants |
| VCIV | Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination | Unknown | 159 participants |
| VCIV | Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination | Mild | 1354 participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination | Unknown | 42 participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination | Moderate | 6 participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination | Severe | 1 participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination | Mild | 262 participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination | Total with Reaction | 311 participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination | No Reaction | 3309 participants |
Secondary
Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination
Number of Subjects With Non-Serious Systemic Reactions During the Entire Follow-Up Period
Time frame: 180 days
Population: Safety Analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VCIV | Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination | No Reaction | 2312 participants |
| VCIV | Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination | Mild | 957 participants |
| VCIV | Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination | Moderate | 250 participants |
| VCIV | Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination | Total with Reaction | 1311 participants |
| VCIV | Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination | Severe | 53 participants |
| VCIV | Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination | Unknown | 51 participants |
| Placebo | Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination | Severe | 17 participants |
| Placebo | Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination | No Reaction | 2748 participants |
| Placebo | Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination | Total with Reaction | 872 participants |
| Placebo | Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination | Mild | 648 participants |
| Placebo | Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination | Unknown | 34 participants |
| Placebo | Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination | Moderate | 173 participants |
Secondary
HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21
Time frame: 21 days
Population: Immunogenicity Analysis
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VCIV | HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 | A/H1N1 | 194.1 Titers |
| VCIV | HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 | A/H3N2 | 299.7 Titers |
| VCIV | HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 | B | 301.7 Titers |
| Placebo | HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 | A/H1N1 | 17.7 Titers |
| Placebo | HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 | A/H3N2 | 22.4 Titers |
| Placebo | HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 | B | 39.3 Titers |
Secondary
Number of Subjects Who Developed Influenza Infection 21 Days to 180 Days Post-vaccination With Infecting Strain Matching the Strains Contained in the Vaccine
Number of subjects with influenza infection confirmed by viral culture and typing and/or RT-PCR analysis of naso-pharyngeal specimens that are antigenically similar to the strains contained in the vaccine
Time frame: 180 days
Population: Intent-to-Treat Analysis
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VCIV | Number of Subjects Who Developed Influenza Infection 21 Days to 180 Days Post-vaccination With Infecting Strain Matching the Strains Contained in the Vaccine | Influenza Infection A/H1N1 | 14 Participants |
| VCIV | Number of Subjects Who Developed Influenza Infection 21 Days to 180 Days Post-vaccination With Infecting Strain Matching the Strains Contained in the Vaccine | Influenza Infection B | 8 Participants |
| VCIV | Number of Subjects Who Developed Influenza Infection 21 Days to 180 Days Post-vaccination With Infecting Strain Matching the Strains Contained in the Vaccine | Influenza Infection A/H3N2 | 2 Participants |
| VCIV | Number of Subjects Who Developed Influenza Infection 21 Days to 180 Days Post-vaccination With Infecting Strain Matching the Strains Contained in the Vaccine | No Influenza Infection | 3595 Participants |
| Placebo | Number of Subjects Who Developed Influenza Infection 21 Days to 180 Days Post-vaccination With Infecting Strain Matching the Strains Contained in the Vaccine | No Influenza Infection | 3537 Participants |
| Placebo | Number of Subjects Who Developed Influenza Infection 21 Days to 180 Days Post-vaccination With Infecting Strain Matching the Strains Contained in the Vaccine | Influenza Infection A/H1N1 | 56 Participants |
| Placebo | Number of Subjects Who Developed Influenza Infection 21 Days to 180 Days Post-vaccination With Infecting Strain Matching the Strains Contained in the Vaccine | Influenza Infection A/H3N2 | 4 Participants |
| Placebo | Number of Subjects Who Developed Influenza Infection 21 Days to 180 Days Post-vaccination With Infecting Strain Matching the Strains Contained in the Vaccine | Influenza Infection B | 20 Participants |
Secondary
Number of Subjects Who Developed Influenza Infection Between 21 and 180 Days Post-vaccination, Regardless of Whether the Infecting Strain Matched the Vaccine Strains Antigenically
Number of subjects with influenza infection as confirmed by viral culture and typing of naso-pharyngeal specimens regardless of whether the isolate is antigenically matched to the strains contained in the vaccine
Time frame: 180 days
Population: Intent-to-Treat analysis
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VCIV | Number of Subjects Who Developed Influenza Infection Between 21 and 180 Days Post-vaccination, Regardless of Whether the Infecting Strain Matched the Vaccine Strains Antigenically | Influenza Infection A/H1N1 | 11 Participants |
| VCIV | Number of Subjects Who Developed Influenza Infection Between 21 and 180 Days Post-vaccination, Regardless of Whether the Infecting Strain Matched the Vaccine Strains Antigenically | Influenza Infection A/H3N2 | 2 Participants |
| VCIV | Number of Subjects Who Developed Influenza Infection Between 21 and 180 Days Post-vaccination, Regardless of Whether the Infecting Strain Matched the Vaccine Strains Antigenically | Influenza Infection B | 8 Participants |
| VCIV | Number of Subjects Who Developed Influenza Infection Between 21 and 180 Days Post-vaccination, Regardless of Whether the Infecting Strain Matched the Vaccine Strains Antigenically | No Influenza Infection | 3598 Participants |
| Placebo | Number of Subjects Who Developed Influenza Infection Between 21 and 180 Days Post-vaccination, Regardless of Whether the Infecting Strain Matched the Vaccine Strains Antigenically | No Influenza Infection | 3543 Participants |
| Placebo | Number of Subjects Who Developed Influenza Infection Between 21 and 180 Days Post-vaccination, Regardless of Whether the Infecting Strain Matched the Vaccine Strains Antigenically | Influenza Infection A/H1N1 | 52 Participants |
| Placebo | Number of Subjects Who Developed Influenza Infection Between 21 and 180 Days Post-vaccination, Regardless of Whether the Infecting Strain Matched the Vaccine Strains Antigenically | Influenza Infection B | 18 Participants |
| Placebo | Number of Subjects Who Developed Influenza Infection Between 21 and 180 Days Post-vaccination, Regardless of Whether the Infecting Strain Matched the Vaccine Strains Antigenically | Influenza Infection A/H3N2 | 4 Participants |
Secondary
Percentage of Subjects Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine at Day 21
Seroconversion is defined as a ≥ 4-fold increase in HIA titer from baseline or a HIA titer ≥ 40 when there is no detectable HIA titer (HIA titer \<10) at baseline.
Time frame: 21 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VCIV | Percentage of Subjects Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine at Day 21 | B | 65.7 percentage of participants |
| VCIV | Percentage of Subjects Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine at Day 21 | A/H1N1 | 70.4 percentage of participants |
| VCIV | Percentage of Subjects Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine at Day 21 | A/H3N2 | 79.1 percentage of participants |
| Placebo | Percentage of Subjects Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine at Day 21 | A/H3N2 | 0.9 percentage of participants |
| Placebo | Percentage of Subjects Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine at Day 21 | B | 1.3 percentage of participants |
| Placebo | Percentage of Subjects Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine at Day 21 | A/H1N1 | 1.2 percentage of participants |
Secondary
Percentage of Subjects With Seroprotective Antibody Titer [Reciprocal HIA Titer ≥ 40] for Each of the Three Antigens Contained in the Vaccine at Day 21
Time frame: 21 days
Population: Immunogenicity Analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VCIV | Percentage of Subjects With Seroprotective Antibody Titer [Reciprocal HIA Titer ≥ 40] for Each of the Three Antigens Contained in the Vaccine at Day 21 | A/H1N1 | 88 percentage of participants |
| VCIV | Percentage of Subjects With Seroprotective Antibody Titer [Reciprocal HIA Titer ≥ 40] for Each of the Three Antigens Contained in the Vaccine at Day 21 | A/H3N2 | 93.3 percentage of participants |
| VCIV | Percentage of Subjects With Seroprotective Antibody Titer [Reciprocal HIA Titer ≥ 40] for Each of the Three Antigens Contained in the Vaccine at Day 21 | B | 97.1 percentage of participants |
| Placebo | Percentage of Subjects With Seroprotective Antibody Titer [Reciprocal HIA Titer ≥ 40] for Each of the Three Antigens Contained in the Vaccine at Day 21 | A/H1N1 | 29.8 percentage of participants |
| Placebo | Percentage of Subjects With Seroprotective Antibody Titer [Reciprocal HIA Titer ≥ 40] for Each of the Three Antigens Contained in the Vaccine at Day 21 | A/H3N2 | 38.8 percentage of participants |
| Placebo | Percentage of Subjects With Seroprotective Antibody Titer [Reciprocal HIA Titer ≥ 40] for Each of the Three Antigens Contained in the Vaccine at Day 21 | B | 56.2 percentage of participants |