Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults (NCT NCT01144299)

NCT ID: NCT01144299

Last Updated: 2018-09-24

Results Overview

Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 114 participants
• Primary outcome timeframe: Day 0 and Day 21
• Results posted on: 2018-09-24

Participant Flow

Participant milestones

Measure	Fluarix Adult Group Subjects aged 18 to 60 years received one dose of Fluarix™.	Fluarix Elderly Group Subjects aged \> 60 years received one dose of Fluarix™.
Overall Study STARTED	60	54
Overall Study COMPLETED	58	54
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Fluarix Adult Group Subjects aged 18 to 60 years received one dose of Fluarix™.	Fluarix Elderly Group Subjects aged \> 60 years received one dose of Fluarix™.
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults

Baseline characteristics by cohort

Measure	Fluarix Adult Group n=60 Participants Subjects aged 18 to 60 years received one dose of Fluarix™.	Fluarix Elderly Group n=54 Participants Subjects aged \> 60 years received one dose of Fluarix™.	Total n=114 Participants Total of all reporting groups
Age, Continuous	37.1 Years STANDARD_DEVIATION 13.10 • n=5 Participants	68.6 Years STANDARD_DEVIATION 5.08 • n=7 Participants	52.1 Years STANDARD_DEVIATION 18.83 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	26 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 and Day 21

Population: Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data

Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains

Outcome measures

Measure	Fluarix Adult Group n=55 Participants Subjects aged 18 to 60 years received one dose of Fluarix™.	Fluarix Elderly Group n=53 Participants Subjects aged \> 60 years received one dose of Fluarix™.
Hemagglutination Inhibition (HI) Antibody Titer A/California (Day 0)	10.2 titer Interval 7.7 to 13.6	8.7 titer Interval 6.6 to 11.4
Hemagglutination Inhibition (HI) Antibody Titer A/California (Day 21)	314.1 titer Interval 237.5 to 415.4	89.4 titer Interval 60.1 to 133.0
Hemagglutination Inhibition (HI) Antibody Titer A/Victoria (Day 0)	15.2 titer Interval 11.6 to 20.0	10.5 titer Interval 8.3 to 13.3
Hemagglutination Inhibition (HI) Antibody Titer A/Victoria (Day 21)	89.6 titer Interval 70.8 to 113.3	75.4 titer Interval 56.8 to 100.2
Hemagglutination Inhibition (HI) Antibody Titer B/Brisbane (Day 0)	36.3 titer Interval 26.4 to 50.1	42.1 titer Interval 30.6 to 57.9
Hemagglutination Inhibition (HI) Antibody Titer B/Brisbane (Day 21)	271.6 titer Interval 213.3 to 345.9	132.3 titer Interval 99.0 to 176.9

PRIMARY outcome

Timeframe: Day 0 and Day 21

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data

A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40

Outcome measures

Measure	Fluarix Adult Group n=55 Participants Subjects aged 18 to 60 years received one dose of Fluarix™.	Fluarix Elderly Group n=53 Participants Subjects aged \> 60 years received one dose of Fluarix™.
Number of Seroprotected Subjects A/California (Day 0)	9 Participants	4 Participants
Number of Seroprotected Subjects A/California (Day 21)	54 Participants	41 Participants
Number of Seroprotected Subjects A/Victoria (Day 0)	14 Participants	7 Participants
Number of Seroprotected Subjects A/Victoria (Day 21)	48 Participants	45 Participants
Number of Seroprotected Subjects B/Brisbane (Day 0)	29 Participants	29 Participants
Number of Seroprotected Subjects B/Brisbane (Day 21)	55 Participants	47 Participants

PRIMARY outcome

Timeframe: Day 21

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data

A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4

Outcome measures

Measure	Fluarix Adult Group n=55 Participants Subjects aged 18 to 60 years received one dose of Fluarix™.	Fluarix Elderly Group n=53 Participants Subjects aged \> 60 years received one dose of Fluarix™.
Number of Seroconverted Subjects A/California	50 Participants	35 Participants
Number of Seroconverted Subjects A/Victoria	35 Participants	36 Participants
Number of Seroconverted Subjects B/Brisbane	33 Participants	18 Participants

PRIMARY outcome

Timeframe: Day 21

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data

Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains

Outcome measures

Measure	Fluarix Adult Group n=55 Participants Subjects aged 18 to 60 years received one dose of Fluarix™.	Fluarix Elderly Group n=53 Participants Subjects aged \> 60 years received one dose of Fluarix™.
Seroconversion Factor A/California	30.8 fold change Interval 21.8 to 43.5	10.3 fold change Interval 7.0 to 15.2
Seroconversion Factor A/Victoria	5.9 fold change Interval 4.5 to 7.8	7.2 fold change Interval 5.1 to 10.1
Seroconversion Factor B/Brisbane	7.5 fold change Interval 5.1 to 11.0	3.1 fold change Interval 2.2 to 4.4

PRIMARY outcome

Timeframe: Day 21

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data

Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40

Outcome measures

Measure	Fluarix Adult Group n=46 Participants Subjects aged 18 to 60 years received one dose of Fluarix™.	Fluarix Elderly Group n=49 Participants Subjects aged \> 60 years received one dose of Fluarix™.
Seroprotection Power A/California	45 Participants	37 Participants
Seroprotection Power A/Victoria	34 Participants	38 Participants
Seroprotection Power B/Brisbane	26 Participants	18 Participants

SECONDARY outcome

Timeframe: During the 4-day (Day 0-3) post-vaccination period

Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data

Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.

Outcome measures

Measure	Fluarix Adult Group n=59 Participants Subjects aged 18 to 60 years received one dose of Fluarix™.	Fluarix Elderly Group n=54 Participants Subjects aged \> 60 years received one dose of Fluarix™.
Number of Subjects Reporting Solicited Local Symptoms Ecchymosis	3 Participants	0 Participants
Number of Subjects Reporting Solicited Local Symptoms Induration	9 Participants	9 Participants
Number of Subjects Reporting Solicited Local Symptoms Pain	40 Participants	17 Participants
Number of Subjects Reporting Solicited Local Symptoms Redness	10 Participants	15 Participants
Number of Subjects Reporting Solicited Local Symptoms Swelling	8 Participants	7 Participants

SECONDARY outcome

Timeframe: During the 4-day (Day 0-3) post-vaccination period

Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data

Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever.

Outcome measures

Measure	Fluarix Adult Group n=59 Participants Subjects aged 18 to 60 years received one dose of Fluarix™.	Fluarix Elderly Group n=54 Participants Subjects aged \> 60 years received one dose of Fluarix™.
Number of Subjects Reporting Solicited General Symptoms Arthralgia	6 Participants	4 Participants
Number of Subjects Reporting Solicited General Symptoms Fatigue	13 Participants	8 Participants
Number of Subjects Reporting Solicited General Symptoms Headache	11 Participants	9 Participants
Number of Subjects Reporting Solicited General Symptoms Myalgia	11 Participants	9 Participants
Number of Subjects Reporting Solicited General Symptoms Shivering	5 Participants	3 Participants
Number of Subjects Reporting Solicited General Symptoms Fever (Axillary)	1 Participants	0 Participants
Number of Subjects Reporting Solicited General Symptoms Sweating	3 Participants	3 Participants

SECONDARY outcome

Timeframe: During the 21-day (Day 0-20) post-vaccination period

An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product

Outcome measures

Measure	Fluarix Adult Group n=60 Participants Subjects aged 18 to 60 years received one dose of Fluarix™.	Fluarix Elderly Group n=54 Participants Subjects aged \> 60 years received one dose of Fluarix™.
Number of Subjects Reporting Unsolicited Adverse Events (AE)	12 Participants	6 Participants

SECONDARY outcome

Timeframe: During the entire study period (From Day 0 up to Day 21)

An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Outcome measures

Measure	Fluarix Adult Group n=60 Participants Subjects aged 18 to 60 years received one dose of Fluarix™.	Fluarix Elderly Group n=54 Participants Subjects aged \> 60 years received one dose of Fluarix™.
Number of Subjects Reporting Serious Adverse Events (SAE)	0 Participants	0 Participants

Adverse Events

Fluarix Adult Group

Serious events: 0 serious events

Other events: 50 other events

Deaths: 0 deaths

Fluarix Elderly Group

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fluarix Adult Group n=60 participants at risk Subjects aged 18 to 60 years received one dose of Fluarix™.	Fluarix Elderly Group n=54 participants at risk Subjects aged \> 60 years received one dose of Fluarix™.
General disorders Ecchymosis	5.0% 3/60	0.00% 0/54
General disorders Induration	15.0% 9/60	16.7% 9/54
General disorders Pain	66.7% 40/60	31.5% 17/54
General disorders Redness	16.7% 10/60	27.8% 15/54
General disorders Swelling	13.3% 8/60	13.0% 7/54
General disorders Arthralgia	10.0% 6/60	7.4% 4/54
General disorders Fatigue	21.7% 13/60	14.8% 8/54
General disorders Headache	18.3% 11/60	16.7% 9/54
General disorders Myalgia	18.3% 11/60	16.7% 9/54
General disorders Shivering	8.3% 5/60	5.6% 3/54
General disorders Sweating	5.0% 3/60	5.6% 3/54
Respiratory, thoracic and mediastinal disorders Cough	5.0% 3/60	1.9% 1/54

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER