Trial Outcomes & Findings for Immunogenicity and Safety Study of GSK Biologicals' Fluviral® (2008 - 2009 Season) in Adults Over 18 Years (NCT NCT00718120)

NCT ID: NCT00718120

Last Updated: 2019-06-26

Results Overview

Titers, given as geometric mean titers (GMTs), are presented for all three vaccine influenza virus strains.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 110 participants
• Primary outcome timeframe: At Day 0 and 21
• Results posted on: 2019-06-26

Participant Flow

Participant milestones

Measure	Fluviral Adult Group Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.	Fluviral Elderly Group Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
Overall Study STARTED	55	55
Overall Study COMPLETED	55	55
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunogenicity and Safety Study of GSK Biologicals' Fluviral® (2008 - 2009 Season) in Adults Over 18 Years

Baseline characteristics by cohort

Measure	Fluviral Adult Group n=55 Participants Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.	Fluviral Elderly Group n=55 Participants Subjects aged more than 60 years received a single dose of Fluviral® vaccine.	Total n=110 Participants Total of all reporting groups
Age, Continuous	40.1 years STANDARD_DEVIATION 12.16 • n=5 Participants	66.4 years STANDARD_DEVIATION 4.61 • n=7 Participants	53.2 years STANDARD_DEVIATION 16.08 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	35 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 0 and 21

Titers, given as geometric mean titers (GMTs), are presented for all three vaccine influenza virus strains.

Outcome measures

Measure	Fluviral Adult Group n=55 Participants Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.	Fluviral Elderly Group n=55 Participants Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
Hemagglutination Inhibition (HI) Antibody Titers B/Florida [Day 0]	59.8 titer Interval 42.1 to 85.0	51.4 titer Interval 36.3 to 72.8
Hemagglutination Inhibition (HI) Antibody Titers B/Florida [Day 21]	485.0 titer Interval 378.9 to 620.8	256.6 titer Interval 195.7 to 336.4
Hemagglutination Inhibition (HI) Antibody Titers A/Brisbane (H1N1) [Day 0]	19.5 titer Interval 13.8 to 27.5	13.9 titer Interval 10.7 to 18.2
Hemagglutination Inhibition (HI) Antibody Titers A/Brisbane (H1N1) [Day 21]	116.0 titer Interval 88.4 to 152.2	47.1 titer Interval 33.0 to 67.2
Hemagglutination Inhibition (HI) Antibody Titers A/Uruguay (H3N2) [Day 0]	19.1 titer Interval 12.9 to 28.3	23.2 titer Interval 16.0 to 33.8
Hemagglutination Inhibition (HI) Antibody Titers A/Uruguay (H3N2) [Day 21]	244.0 titer Interval 173.5 to 343.2	170.3 titer Interval 118.2 to 245.3

PRIMARY outcome

Timeframe: At Day 21

Seroconversion, defined as 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 at least a 4-fold increase in post-vaccination serum HI titer, is presented for all three vaccine influenza virus strains.

Outcome measures

Measure	Fluviral Adult Group n=55 Participants Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.	Fluviral Elderly Group n=55 Participants Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
Number of Seroconverted Subjects A/Brisbane (H1N1)	28 subjects	18 subjects
Number of Seroconverted Subjects A/Uruguay (H3N2)	40 subjects	35 subjects
Number of Seroconverted Subjects B/Florida	38 subjects	25 subjects

PRIMARY outcome

Timeframe: At Day 0 and 21

Seroprotection, defined as a serum HI antibody titer ≥ 1:40, is presented for all three vaccine influenza virus strains.

Outcome measures

Measure	Fluviral Adult Group n=55 Participants Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.	Fluviral Elderly Group n=55 Participants Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
Number of Seroprotected Subjects A/Brisbane (H1N1) [Day 21]	52 subjects	36 subjects
Number of Seroprotected Subjects A/Brisbane (H1N1) [Day 0]	21 subjects	15 subjects
Number of Seroprotected Subjects A/Uruguay (H3N2) [Day 0]	21 subjects	20 subjects
Number of Seroprotected Subjects A/Uruguay (H3N2) [Day 21]	53 subjects	50 subjects
Number of Seroprotected Subjects B/Florida [Day 0]	36 subjects	37 subjects
Number of Seroprotected Subjects B/Florida [Day 21]	55 subjects	55 subjects

PRIMARY outcome

Timeframe: At Day 21

The fold increase in serum HI antibody titer post-vaccination (Day 21) compared to pre-vaccination (Day 0) was calculated by dividing the geometric mean antibody titers of Day 21 by those of Day 0. Data are presented for all three vaccine influenza virus strains.

Outcome measures

Measure	Fluviral Adult Group n=55 Participants Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.	Fluviral Elderly Group n=55 Participants Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
Fold Increase From Baseline in Serum HI Antibody Titer A/Brisbane (H1N1)	6.0 fold increase	3.4 fold increase
Fold Increase From Baseline in Serum HI Antibody Titer A/Uruguay (H3N2)	12.8 fold increase	7.3 fold increase
Fold Increase From Baseline in Serum HI Antibody Titer B/Florida	8.1 fold increase	5.0 fold increase

SECONDARY outcome

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

Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, and fever.

Outcome measures

Measure	Fluviral Adult Group n=55 Participants Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.	Fluviral Elderly Group n=55 Participants Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
Number of Subjects Reporting Solicited Symptoms Fatigue	10 subjects	8 subjects
Number of Subjects Reporting Solicited Symptoms Headache	14 subjects	6 subjects
Number of Subjects Reporting Solicited Symptoms Pain	36 subjects	13 subjects
Number of Subjects Reporting Solicited Symptoms Redness	0 subjects	0 subjects
Number of Subjects Reporting Solicited Symptoms Swelling	2 subjects	0 subjects
Number of Subjects Reporting Solicited Symptoms Bronchospasm	1 subjects	2 subjects
Number of Subjects Reporting Solicited Symptoms Chills	2 subjects	0 subjects
Number of Subjects Reporting Solicited Symptoms Cough	1 subjects	4 subjects
Number of Subjects Reporting Solicited Symptoms Joint pain at other location	5 subjects	6 subjects
Number of Subjects Reporting Solicited Symptoms Muscle aches	19 subjects	11 subjects
Number of Subjects Reporting Solicited Symptoms Red eyes	3 subjects	4 subjects
Number of Subjects Reporting Solicited Symptoms Sore throat	7 subjects	3 subjects
Number of Subjects Reporting Solicited Symptoms Swelling of the face	0 subjects	0 subjects
Number of Subjects Reporting Solicited Symptoms Fever	1 subjects	0 subjects

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	Fluviral Adult Group n=55 Participants Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.	Fluviral Elderly Group n=55 Participants Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
Number of Subjects Reporting Unsolicited Adverse Events (AE)	9 subjects	8 subjects

SECONDARY outcome

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

An SAE is any untoward medical occurrence that: results in death, is life-threatening, 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	Fluviral Adult Group n=55 Participants Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.	Fluviral Elderly Group n=55 Participants Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
Number of Subjects Reporting Serious Adverse Events (SAE)	0 subjects	1 subjects

Adverse Events

Fluviral Adult Group

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Fluviral Elderly Group

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fluviral Adult Group n=55 participants at risk Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.	Fluviral Elderly Group n=55 participants at risk Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
Immune system disorders Anaphylactic reaction	0.00% 0/55 • Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	1.8% 1/55 • Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.

Other adverse events

Measure	Fluviral Adult Group n=55 participants at risk Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.	Fluviral Elderly Group n=55 participants at risk Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
General disorders Cough	1.8% 1/55 • Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	7.3% 4/55 • Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Fatigue	18.2% 10/55 • Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	14.5% 8/55 • Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Headache	25.5% 14/55 • Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	10.9% 6/55 • Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Joint pain at other location	9.1% 5/55 • Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	10.9% 6/55 • Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Muscle aches	34.5% 19/55 • Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	20.0% 11/55 • Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Red eyes	5.5% 3/55 • Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	7.3% 4/55 • Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Sore throat	12.7% 7/55 • Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	5.5% 3/55 • Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Pain at the injection site	65.5% 36/55 • Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	23.6% 13/55 • Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period. For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.

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