Influenza
Conditions
Keywords
Influenza
Brief summary
The hypothesis for this trial is that the incidence of a pre-defined composite of common systemic hypersensitivity adverse events for Flublok recipients is non-inferior to that reported for licensed IIV recipients. Another hypothesis is that the safety and reactogenicity of Flublok is clinically acceptable, i.e. consistent with the overall safety profiles previously observed with Flublok and with the licensed comparator.
Detailed description
The Advisory Committee on Immunization Practices (ACIP) recommends that all people aged 6 months and older be immunized to prevent influenza. Currently the only approved influenza vaccine across the entire age group is inactivated influenza vaccine (IIV). A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Additional safety and, ultimately efficacy, data is needed to support use in adults ≥50 years of age, an important age group as adults ≥65 years of age are among those at increased risk of influenza complications.
Interventions
BIOLOGICALFlublok
A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.
BIOLOGICALAfluria
Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.
Sponsors
Protein Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Ambulatory adults aged 50 years and older 2. Medically stable, as determined by medical history and targeted physical examination based on medical history, if appropriate 3. Able to understand and comply with planned study procedures 4. Provides written informed consent prior to initiation of any study procedure.
Exclusion criteria
1. Known contraindication to either study vaccine (see product package inserts) 2. Receipt of any other influenza or other vaccine within 30 days prior to enrollment in this study. 3. Receipt of any new medication within 30 days prior to enrollment in this study 4. Plans to participate in any investigation involving an investigational product during this study. 5. Pre-existence of atopic dermatitis or any other cutaneous disorder that could complicate the evaluation of potential primary endpoints. 6. Any clinical or social circumstance that in the opinion of the investigator could interfere with compliance with study procedures or interfere with the interpretation of clinical data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Common Hypersensitivity Reactions as Measure of Safety | 30 Days | Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration | 30 Days | Subjects with at least one serious adverse event and subjects with at least one medically-attended unsolicited adverse event occurring during the 30 days following vaccine administration |
| Number of Participants With Local and Systemic Events Reported as a Measure of Safety | 7 Days | Number of solicited local and systemic events of reactogenicity reported with the help of a memory aid during the seven days following vaccine administration. |
| Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety | 7 Days | Subjects with at least one pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or non-dependent edema on Day 0 and for Days 0 to 7 following vaccine administration |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited at outpatient medical clinics over a period of five weeks.
Participants by arm
| Arm | Count |
|---|---|
| Flublok Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL
Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions. | 1,314 |
| Afluria Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL
Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs. | 1,313 |
| Total | 2,627 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 6 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Afluria | Flublok | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 648 Participants | 642 Participants | 1290 Participants |
| Age, Categorical Between 18 and 65 years | 665 Participants | 672 Participants | 1337 Participants |
| Age, Continuous | 64 years | 64 years | 64 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 99 Participants | 105 Participants | 204 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1214 Participants | 1209 Participants | 2423 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 7 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 212 Participants | 197 Participants | 409 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1083 Participants | 1098 Participants | 2181 Participants |
| Region of Enrollment United States | 1313 participants | 1314 participants | 2627 participants |
| Sex: Female, Male Female | 725 Participants | 730 Participants | 1455 Participants |
| Sex: Female, Male Male | 588 Participants | 584 Participants | 1172 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 1,314 | 16 / 1,313 |
| serious Total, serious adverse events | 5 / 1,314 | 10 / 1,313 |
Outcome results
Primary
Number of Participants With Common Hypersensitivity Reactions as Measure of Safety
Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration.
Time frame: 30 Days
Population: The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flublok | Number of Participants With Common Hypersensitivity Reactions as Measure of Safety | 31 participants |
| Afluria | Number of Participants With Common Hypersensitivity Reactions as Measure of Safety | 21 participants |
Secondary
Number of Participants With Local and Systemic Events Reported as a Measure of Safety
Number of solicited local and systemic events of reactogenicity reported with the help of a memory aid during the seven days following vaccine administration.
Time frame: 7 Days
Population: The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flublok | Number of Participants With Local and Systemic Events Reported as a Measure of Safety | 432 participants |
| Afluria | Number of Participants With Local and Systemic Events Reported as a Measure of Safety | 480 participants |
Secondary
Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety
Subjects with at least one pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or non-dependent edema on Day 0 and for Days 0 to 7 following vaccine administration
Time frame: 7 Days
Population: The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flublok | Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety | Day 0 | 5 participants |
| Flublok | Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety | Days 0-7 | 25 participants |
| Afluria | Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety | Day 0 | 3 participants |
| Afluria | Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety | Days 0-7 | 12 participants |
Secondary
Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration
Subjects with at least one serious adverse event and subjects with at least one medically-attended unsolicited adverse event occurring during the 30 days following vaccine administration
Time frame: 30 Days
Population: The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flublok | Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration | Medically-Attended Unsolicited Adverse Events | 53 participants |
| Flublok | Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration | Serious Adverse Events (SAEs) | 5 participants |
| Afluria | Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration | Serious Adverse Events (SAEs) | 10 participants |
| Afluria | Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration | Medically-Attended Unsolicited Adverse Events | 51 participants |