Influenza
Conditions
Brief summary
The primary purpose of this study is to demonstrate the efficacy of an investigational Vero-cell derived influenza vaccine to prevent infection in an adult population with an influenza virus that is antigenically similar to one of the three strains in the vaccine. All subjects will be randomized to receive a single 0.5 ml intramuscular injection from one of three lots of seasonal Vero-cell derived influenza vaccine or saline placebo. Subjects will be monitored for 180 days following vaccination for occurrence of adverse events. For determining antibody response, subjects will have one blood draw before and one blood draw 21 days after vaccination.
Interventions
BIOLOGICALInactivated seasonal influenza vaccine (split virus, Vero cell-derived)
Trivalent, non-adjuvanted vaccine; dose: 0.5 ml
Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml
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
Male and female subjects who * are 18 to 49 years of age, inclusive, on the day of screening * have an understanding of the study, agree to its provisions and give written informed consent prior to study entry * If female and capable of bearing children - have a negative urine pregnancy test result within 24 hours of the vaccination on Study Day 0 and agree to employ adequate birth control measures. For the purposes of this study adequate birth control measures incorporate two types of the following FDA approved birth control measures through 60 days after the vaccination: hormonal types of birth control (such as implants, birth control pills, patches or other methods) or an intrauterine device, OR an additional barrier type of birth control measure (i.e., condoms, diaphragms, cervical caps, etc.).
Exclusion criteria
Subjects who have any of the risk factors for complications from influenza infection as defined by the Centers for Disease Control and Prevention (CDC): * 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) * immunosuppression (including immunosuppression caused by medications 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 a 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 Subjects are also excluded if they * are unable to lead an independent life as a result of either physical or mental handicap * have a history of severe allergic reactions or anaphylaxis * have an oral temperature of \>= 99.5° F (37.5°C) on the day of vaccination in this study. \[NOTE: Subjects meeting this exclusion criterion may be rescheduled for vaccination and study entry at a later date provided: 1.) oral temperature has decreased to \< 99.5°F (37.5°C) on rescheduled date, 2.) all other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens | 21 days to 180 days after the date of vaccination | — |
| The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values | 21 Days after vaccination | Consistency of each strain across the 3 different lots shown by comparison of the ratios of geometric mean HIA titers at Day 21 between individual lots for the immunogenicity analysis set. |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | During the entire 180-day follow-up period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Influenza Vaccine Vero-cell derived influenza vaccine
Inactivated seasonal influenza vaccine (split virus, Vero cell-derived): Trivalent, non-adjuvanted vaccine; dose: 0.5 ml | 1,829 |
| Placebo Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine)
Phosphate buffered saline: Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml | 1,841 |
| Total | 3,670 |
Baseline characteristics
| Characteristic | Influenza Vaccine | Total | Placebo |
|---|---|---|---|
| Age, Customized ages 18-49 | 1829 Participants | 3670 Participants | 1841 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 315 Participants | 622 Participants | 307 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1514 Participants | 3048 Participants | 1534 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 21 Participants | 15 Participants |
| Race (NIH/OMB) Asian | 33 Participants | 66 Participants | 33 Participants |
| Race (NIH/OMB) Black or African American | 386 Participants | 762 Participants | 376 Participants |
| Race (NIH/OMB) More than one race | 16 Participants | 31 Participants | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 15 Participants | 29 Participants | 14 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1373 Participants | 2761 Participants | 1388 Participants |
| Region of Enrollment United States | 1829 participants | 3670 participants | 1841 participants |
| Sex: Female, Male Female | 1037 Participants | 2037 Participants | 1000 Participants |
| Sex: Female, Male Male | 792 Participants | 1633 Participants | 841 Participants |
| Weight | 81.60 kg STANDARD_DEVIATION 21.104 | 81.74 kg STANDARD_DEVIATION 20.897 | 81.87 kg STANDARD_DEVIATION 20.694 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 1,829 | 0 / 1,841 |
| other Total, other adverse events | 1,132 / 1,829 | 375 / 1,841 |
| serious Total, serious adverse events | 3 / 1,829 | 0 / 1,841 |
Outcome results
Primary
Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens
Time frame: 21 days to 180 days after the date of vaccination
Population: Intent-to-Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Influenza Vaccine | Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens | 35 Participants |
| Placebo | Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens | 62 Participants |
Primary
The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values
Consistency of each strain across the 3 different lots shown by comparison of the ratios of geometric mean HIA titers at Day 21 between individual lots for the immunogenicity analysis set.
Time frame: 21 Days after vaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influenza Vaccine | The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values | Strain A/H3N2 | 0.94 Geometric Mean Titers |
| Influenza Vaccine | The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values | Strain A/H1N1 | 1.22 Geometric Mean Titers |
| Influenza Vaccine | The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values | Strain B | 0.88 Geometric Mean Titers |
| Placebo | The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values | Strain A/H3N2 | 0.99 Geometric Mean Titers |
| Placebo | The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values | Strain A/H1N1 | 1.10 Geometric Mean Titers |
| Placebo | The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values | Strain B | 0.91 Geometric Mean Titers |
| Influenza Vaccine Lot 3 vs Lot 2 | The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values | Strain A/H1N1 | 0.90 Geometric Mean Titers |
| Influenza Vaccine Lot 3 vs Lot 2 | The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values | Strain B | 1.04 Geometric Mean Titers |
| Influenza Vaccine Lot 3 vs Lot 2 | The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values | Strain A/H3N2 | 1.05 Geometric Mean Titers |
Secondary
Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination
Time frame: During the entire 180-day follow-up period
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Influenza Vaccine | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Systemic Reactions | No Reactions | 1199 Participants |
| Influenza Vaccine | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Local Reactions | No Reactions | 868 Participants |
| Influenza Vaccine | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Systemic Reactions | Mild | 406 Participants |
| Influenza Vaccine | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Local Reactions | Moderate | 99 Participants |
| Influenza Vaccine | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Systemic Reactions | Moderate | 190 Participants |
| Influenza Vaccine | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Local Reactions | Severe | 5 Participants |
| Influenza Vaccine | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Systemic Reactions | Severe | 34 Participants |
| Influenza Vaccine | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Local Reactions | Unknown | 23 Participants |
| Influenza Vaccine | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Systemic Reactions | Unknown | 0 Participants |
| Influenza Vaccine | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Local Reactions | Mild | 834 Participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Systemic Reactions | Unknown | 0 Participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Local Reactions | No Reactions | 1586 Participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Local Reactions | Mild | 237 Participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Local Reactions | Severe | 0 Participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Local Reactions | Unknown | 11 Participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Systemic Reactions | No Reactions | 1442 Participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Systemic Reactions | Mild | 251 Participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Systemic Reactions | Moderate | 132 Participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Systemic Reactions | Severe | 16 Participants |
| Placebo | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Non-Serious Local Reactions | Moderate | 7 Participants |