Influenza
Conditions
Brief summary
This study will evaluate the safety of an influenza (flu) vaccine in Korean men and women aged 65 years and older.
Interventions
BIOLOGICALFluad_MF59-adjuvanted trivalent influenza subunit vaccine
BIOLOGICALVantaflu_MF59-adjuvanted trivalent influenza subunit vaccine
Sponsors
Novartis Vaccines
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Males and females aged 65 years and above on the day of enrollment, who were eligible for seasonal influenza vaccination. 2. In the judgement of the study doctor are determined to be in reasonable health considering their age and able to comply with all study procedures.
Exclusion criteria
1. History of any serious reaction to flu vaccine, or any materials in the vaccine, and to eggs (including ovalbumin) and chicken protein. 2. Receipt of another (inactivated) vaccine within 2 weeks, or receipt of a live vaccine within 4 weeks prior to Study Day 1, or planning to receive some other vaccination before the final study visit (about Day 29 after vaccination). 3. Any condition, which in the opinion of the study doctor, might interfere with the evaluation of the study objective.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Day 1 through Day 4 after vaccination | The number of subjects reporting any solicited local and systemic AEs, following vaccination with Fluad\_aTIV and Vantaflu\_aTIV. |
| Number of Subjects Reporting Unsolicited AEs After Vaccination. | Day 1 through Day 28 post vaccination | The number of subjects reporting any unsolicited AEs following vaccination with Fluad\_aTIV and Vantaflu\_aTIV. |
| Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. | Day 1 through Day 28 post vaccination | The number of subjects reporting any unsolicited AEs, SAEs, AEs leading to withdrawal (WD), AEs of special interest (AESI) following vaccination with Fluad\_aTIV and Vantaflu\_aTIV. |
Countries
South Korea
Participant flow
Recruitment details
Subjects were recruited from 24 study sites in Korea.
Pre-assignment details
All subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| Fluad_aTIV Subjects aged \>65 years received one dose of Fluad\_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine. | 386 |
| Vantaflu_aTIV Subjects aged \>65 years received one dose of Vantaflu\_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine. | 379 |
| Total | 765 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Inappropriate enrollment | 0 | 2 |
Baseline characteristics
| Characteristic | Fluad_aTIV | Vantaflu_aTIV | Total |
|---|---|---|---|
| Age, Continuous | 73.6 years STANDARD_DEVIATION 6 | 73.2 years STANDARD_DEVIATION 6.5 | 73.4 years STANDARD_DEVIATION 6.3 |
| Sex: Female, Male Female | 231 Participants | 225 Participants | 456 Participants |
| Sex: Female, Male Male | 155 Participants | 154 Participants | 309 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 163 / 386 | 155 / 379 |
| serious Total, serious adverse events | 0 / 386 | 0 / 379 |
Outcome results
Primary
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination.
The number of subjects reporting any solicited local and systemic AEs, following vaccination with Fluad\_aTIV and Vantaflu\_aTIV.
Time frame: Day 1 through Day 4 after vaccination
Population: Analysis was done on safety population ie. all subjects in the exposed set who provided postvaccination safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluad_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Any Local | 134 participants |
| Fluad_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Any Systemic | 74 participants |
| Fluad_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Erythema (Type I) | 14 participants |
| Fluad_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Erythema (Type II) | 9 participants |
| Fluad_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Induration (Type I) | 8 participants |
| Fluad_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Induration (Type II) | 5 participants |
| Fluad_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Swelling (Type I) | 17 participants |
| Fluad_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Swelling (Type II) | 5 participants |
| Fluad_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Pain at injection site | 119 participants |
| Fluad_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Tenderness at injection site | 107 participants |
| Fluad_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Chills | 17 participants |
| Fluad_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Myalgia | 44 participants |
| Fluad_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Arthralgia | 6 participants |
| Fluad_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Headache | 24 participants |
| Fluad_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Sweating | 8 participants |
| Fluad_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Fatigue | 29 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Fatigue | 31 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Any Local | 122 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Pain at injection site | 111 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Any Systemic | 72 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Arthralgia | 27 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Erythema (Type I) | 21 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Tenderness at injection site | 98 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Erythema (Type II) | 3 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Sweating | 15 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Induration (Type I) | 14 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Chills | 20 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Induration (Type II) | 0 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Headache | 22 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Swelling (Type I) | 25 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Myalgia | 43 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. | Swelling (Type II) | 3 participants |
Primary
Number of Subjects Reporting Unsolicited AEs After Vaccination.
The number of subjects reporting any unsolicited AEs following vaccination with Fluad\_aTIV and Vantaflu\_aTIV.
Time frame: Day 1 through Day 28 post vaccination
Population: Analysis was done on safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluad_aTIV | Number of Subjects Reporting Unsolicited AEs After Vaccination. | Any AEs | 15 participants |
| Fluad_aTIV | Number of Subjects Reporting Unsolicited AEs After Vaccination. | Possibly/probably related AEs | 3 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Unsolicited AEs After Vaccination. | Any AEs | 18 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Unsolicited AEs After Vaccination. | Possibly/probably related AEs | 1 participants |
Primary
Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination.
The number of subjects reporting any unsolicited AEs, SAEs, AEs leading to withdrawal (WD), AEs of special interest (AESI) following vaccination with Fluad\_aTIV and Vantaflu\_aTIV.
Time frame: Day 1 through Day 28 post vaccination
Population: Analysis was done on safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluad_aTIV | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. | SAEs | 0 participants |
| Fluad_aTIV | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. | At least possibly related SAEs | 0 participants |
| Fluad_aTIV | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. | AEs leading to hospitalization | 0 participants |
| Fluad_aTIV | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. | AEs leading to interruption or delay | 0 participants |
| Fluad_aTIV | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. | AEs resulting in premature withdrawal | 0 participants |
| Fluad_aTIV | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. | Deaths | 0 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. | AEs resulting in premature withdrawal | 0 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. | SAEs | 0 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. | AEs leading to interruption or delay | 0 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. | At least possibly related SAEs | 0 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. | Deaths | 0 participants |
| Vantaflu_aTIV | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. | AEs leading to hospitalization | 0 participants |