Trial Outcomes & Findings for A Post-marketing Study to Monitor the Safety of a MF59-adjuvanted Influenza Vaccine Administered in Korean Subjects Aged 65 Years or Older (NCT NCT01222403)

NCT ID: NCT01222403

Last Updated: 2019-06-12

Results Overview

The number of subjects reporting any solicited local and systemic AEs, following vaccination with Fluad\_aTIV and Vantaflu\_aTIV.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 767 participants
• Primary outcome timeframe: Day 1 through Day 4 after vaccination
• Results posted on: 2019-06-12

Participant Flow

Subjects were recruited from 24 study sites in Korea.

All subjects were included in the trial.

Participant milestones

Measure	Fluad_aTIV Subjects aged \>65 years received one dose of Fluad\_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.	Vantaflu_aTIV Subjects aged \>65 years received one dose of Vantaflu\_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.
Overall Study STARTED	386	381
Overall Study COMPLETED	386	379
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Fluad_aTIV Subjects aged \>65 years received one dose of Fluad\_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.	Vantaflu_aTIV Subjects aged \>65 years received one dose of Vantaflu\_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.
Overall Study Inappropriate enrollment	0	2

Baseline Characteristics

A Post-marketing Study to Monitor the Safety of a MF59-adjuvanted Influenza Vaccine Administered in Korean Subjects Aged 65 Years or Older

Baseline characteristics by cohort

Measure	Fluad_aTIV n=386 Participants Subjects aged \>65 years received one dose of Fluad\_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.	Vantaflu_aTIV n=379 Participants Subjects aged \>65 years received one dose of Vantaflu\_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.	Total n=765 Participants Total of all reporting groups
Age, Continuous	73.6 years STANDARD_DEVIATION 6.0 • n=5 Participants	73.2 years STANDARD_DEVIATION 6.5 • n=7 Participants	73.4 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	231 Participants n=5 Participants	225 Participants n=7 Participants	456 Participants n=5 Participants
Sex: Female, Male Male	155 Participants n=5 Participants	154 Participants n=7 Participants	309 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

The number of subjects reporting any solicited local and systemic AEs, following vaccination with Fluad_aTIV and Vantaflu_aTIV.

Outcome measures

Measure	Fluad_aTIV n=386 Participants Subjects aged \>65 years received one dose of Fluad\_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.	Vantaflu_aTIV n=379 Participants Subjects aged \>65 years received one dose of Vantaflu\_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. Any Local	134 participants	122 participants
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. Any Systemic	74 participants	72 participants
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. Erythema (Type I)	14 participants	21 participants
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. Erythema (Type II)	9 participants	3 participants
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. Induration (Type I)	8 participants	14 participants
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. Induration (Type II)	5 participants	0 participants
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. Swelling (Type I)	17 participants	25 participants
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. Swelling (Type II)	5 participants	3 participants
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. Pain at injection site	119 participants	111 participants
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. Tenderness at injection site	107 participants	98 participants
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. Chills	17 participants	20 participants
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. Myalgia	44 participants	43 participants
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. Arthralgia	6 participants	27 participants
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. Headache	24 participants	22 participants
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. Sweating	8 participants	15 participants
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. Fatigue	29 participants	31 participants

PRIMARY outcome

Timeframe: Day 1 through Day 28 post vaccination

Population: Analysis was done on safety population.

The number of subjects reporting any unsolicited AEs following vaccination with Fluad_aTIV and Vantaflu_aTIV.

Outcome measures

Measure	Fluad_aTIV n=386 Participants Subjects aged \>65 years received one dose of Fluad\_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.	Vantaflu_aTIV n=379 Participants Subjects aged \>65 years received one dose of Vantaflu\_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.
Number of Subjects Reporting Unsolicited AEs After Vaccination. Any AEs	15 participants	18 participants
Number of Subjects Reporting Unsolicited AEs After Vaccination. Possibly/probably related AEs	3 participants	1 participants

PRIMARY outcome

Timeframe: Day 1 through Day 28 post vaccination

Population: Analysis was done on safety population.

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.

Outcome measures

Measure	Fluad_aTIV n=386 Participants Subjects aged \>65 years received one dose of Fluad\_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.	Vantaflu_aTIV n=379 Participants Subjects aged \>65 years received one dose of Vantaflu\_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.
Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. SAEs	0 participants	0 participants
Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. At least possibly related SAEs	0 participants	0 participants
Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. AEs leading to hospitalization	0 participants	0 participants
Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. AEs leading to interruption or delay	0 participants	0 participants
Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. AEs resulting in premature withdrawal	0 participants	0 participants
Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. Deaths	0 participants	0 participants

Adverse Events

Fluad_aTIV

Serious events: 0 serious events

Other events: 163 other events

Deaths: 0 deaths

Vantaflu_aTIV

Serious events: 0 serious events

Other events: 155 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fluad_aTIV n=386 participants at risk Subjects aged \>65 years received one dose of Fluad\_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.	Vantaflu_aTIV n=379 participants at risk Subjects aged \>65 years received one dose of Vantaflu\_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine.
General disorders Injection site pain	33.9% 131/386 • Throughout the study (Day 1 through Day 28). All solicited AEs and unsolicited AEs were collected from Day 1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 28.	31.9% 121/379 • Throughout the study (Day 1 through Day 28). All solicited AEs and unsolicited AEs were collected from Day 1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 28.
General disorders Fatigue	7.5% 29/386 • Throughout the study (Day 1 through Day 28). All solicited AEs and unsolicited AEs were collected from Day 1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 28.	8.2% 31/379 • Throughout the study (Day 1 through Day 28). All solicited AEs and unsolicited AEs were collected from Day 1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 28.
General disorders Injection site swelling	4.4% 17/386 • Throughout the study (Day 1 through Day 28). All solicited AEs and unsolicited AEs were collected from Day 1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 28.	6.6% 25/379 • Throughout the study (Day 1 through Day 28). All solicited AEs and unsolicited AEs were collected from Day 1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 28.
General disorders Injection site erythema	3.6% 14/386 • Throughout the study (Day 1 through Day 28). All solicited AEs and unsolicited AEs were collected from Day 1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 28.	5.5% 21/379 • Throughout the study (Day 1 through Day 28). All solicited AEs and unsolicited AEs were collected from Day 1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 28.
General disorders Chills	4.4% 17/386 • Throughout the study (Day 1 through Day 28). All solicited AEs and unsolicited AEs were collected from Day 1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 28.	5.3% 20/379 • Throughout the study (Day 1 through Day 28). All solicited AEs and unsolicited AEs were collected from Day 1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 28.
Musculoskeletal and connective tissue disorders Myalgia	11.4% 44/386 • Throughout the study (Day 1 through Day 28). All solicited AEs and unsolicited AEs were collected from Day 1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 28.	11.3% 43/379 • Throughout the study (Day 1 through Day 28). All solicited AEs and unsolicited AEs were collected from Day 1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 28.
Musculoskeletal and connective tissue disorders Arthralgia	1.6% 6/386 • Throughout the study (Day 1 through Day 28). All solicited AEs and unsolicited AEs were collected from Day 1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 28.	7.1% 27/379 • Throughout the study (Day 1 through Day 28). All solicited AEs and unsolicited AEs were collected from Day 1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 28.
Nervous system disorders Headache	6.2% 24/386 • Throughout the study (Day 1 through Day 28). All solicited AEs and unsolicited AEs were collected from Day 1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 28.	5.8% 22/379 • Throughout the study (Day 1 through Day 28). All solicited AEs and unsolicited AEs were collected from Day 1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 28.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: RegistryContactVaccinesUS@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60