Trial Outcomes & Findings for Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix (NCT NCT00693706)

NCT ID: NCT00693706

Last Updated: 2018-06-08

Results Overview

Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 200 participants
• Primary outcome timeframe: During the 7-day (Days 0-6) post vaccination period
• Results posted on: 2018-06-08

Participant Flow

Participant milestones

Measure	GSK 1388442A Group Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Study STARTED	101	99
Overall Study COMPLETED	101	98
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	GSK 1388442A Group Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Study Protocol Violation	0	1

Baseline Characteristics

Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix

Baseline characteristics by cohort

Measure	GSK 1388442A Group n=101 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=99 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Total n=200 Participants Total of all reporting groups
Age, Continuous	33.1 Years STANDARD_DEVIATION 10.24 • n=93 Participants	31.6 Years STANDARD_DEVIATION 9.77 • n=4 Participants	32.4 Years STANDARD_DEVIATION 10.0 • n=27 Participants
Sex: Female, Male Female	54 Participants n=93 Participants	52 Participants n=4 Participants	106 Participants n=27 Participants
Sex: Female, Male Male	47 Participants n=93 Participants	47 Participants n=4 Participants	94 Participants n=27 Participants

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the documented dose. The analysis of solicited symptoms based on the Total Vaccinated cohort included only vaccinated subjects and doses with documented safety data (i.e., symptom screen /sheet completed).

Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity.

Outcome measures

Measure	GSK 1388442A Group n=101 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=99 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Solicited Local Symptoms. Pain	48 subjects	48 subjects
Number of Subjects With Solicited Local Symptoms. Redness	1 subjects	0 subjects
Number of Subjects With Solicited Local Symptoms. Swelling	1 subjects	0 subjects

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the documented dose. The analysis of solicited symptoms based on the Total Vaccinated cohort included only vaccinated subjects and doses with documented safety data (i.e., symptom screen /sheet completed).

Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (≥) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination.

Outcome measures

Measure	GSK 1388442A Group n=100 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=99 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Solicited General Symptoms. Arthralgia	2 subjects	4 subjects
Number of Subjects With Solicited General Symptoms. Temperature ≥ 38.0°C	1 subjects	0 subjects
Number of Subjects With Solicited General Symptoms. Fatigue	19 subjects	15 subjects
Number of Subjects With Solicited General Symptoms. Headache	24 subjects	21 subjects
Number of Subjects With Solicited General Symptoms. Muscle aches	15 subjects	17 subjects
Number of Subjects With Solicited General Symptoms. Shivering	3 subjects	2 subjects

PRIMARY outcome

Timeframe: During the entire study period (Days 0-182)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination.

Outcome measures

Measure	GSK 1388442A Group n=101 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=99 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Medically Attended Adverse Events (MAEs).	4 subjects	7 subjects

PRIMARY outcome

Timeframe: During the entire study period (Days 0-182)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.

Outcome measures

Measure	GSK 1388442A Group n=101 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=99 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With New Onset of Chronic Diseases (NOCDs).	0 subjects	0 subjects

PRIMARY outcome

Timeframe: During the 90-day (Days 0-89) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Unsolicited AEs cover 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. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.

Outcome measures

Measure	GSK 1388442A Group n=101 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=99 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Unsolicited Adverse Events (AEs).	28 subjects	21 subjects

PRIMARY outcome

Timeframe: During the entire study period (Days 0-182)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination.

Outcome measures

Measure	GSK 1388442A Group n=101 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=99 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Serious Adverse Events (SAEs).	1 subjects	0 subjects

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.

Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)

Outcome measures

Measure	GSK 1388442A Group n=100 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=98 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease. MALAY.	316.6 titers Interval 255.4 to 392.5	326.8 titers Interval 264.9 to 403.3
Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease. H1N1	183.7 titers Interval 136.1 to 248.0	501.4 titers Interval 397.8 to 632.0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease. H3N2	333.5 titers Interval 278.5 to 399.3	315.5 titers Interval 261.1 to 381.2

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.

A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)

Outcome measures

Measure	GSK 1388442A Group n=100 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=98 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. H1N1	90 subjects	97 subjects
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. H3N2	98 subjects	98 subjects
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. MALAY.	99 subjects	96 subjects

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)

Outcome measures

Measure	GSK 1388442A Group n=100 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=98 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. H3N2	68 subjects	66 subjects
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. MALAY.	74 subjects	67 subjects
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. H1N1	72 subjects	79 subjects

PRIMARY outcome

Timeframe: At Day 0 and Day 21

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.

GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)

Outcome measures

Measure	GSK 1388442A Group n=100 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=98 Participants Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease. H1N1	10.9 fold rise Interval 8.0 to 14.9	17.8 fold rise Interval 12.8 to 24.7
Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease. H3N2	10.1 fold rise Interval 7.4 to 13.9	7.5 fold rise Interval 5.6 to 10.1
Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease. MALAY.	12.3 fold rise Interval 9.0 to 16.8	10.5 fold rise Interval 7.7 to 14.3

Adverse Events

GSK 1388442A Group

Serious events: 1 serious events

Other events: 64 other events

Deaths: 0 deaths

Fluarix Group

Serious events: 0 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Measure	GSK 1388442A Group n=101 participants at risk Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=99 participants at risk Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.99% 1/101 • SAE(s): during the entire study period (Days 0-182); Unsolicited AE(s): during the 90-day (Days 0-89) post-vaccination period; Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period.	0.00% 0/99 • SAE(s): during the entire study period (Days 0-182); Unsolicited AE(s): during the 90-day (Days 0-89) post-vaccination period; Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period.

Other adverse events

Measure	GSK 1388442A Group n=101 participants at risk Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=99 participants at risk Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
General disorders Pain	47.5% 48/101 • SAE(s): during the entire study period (Days 0-182); Unsolicited AE(s): during the 90-day (Days 0-89) post-vaccination period; Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period.	48.5% 48/99 • SAE(s): during the entire study period (Days 0-182); Unsolicited AE(s): during the 90-day (Days 0-89) post-vaccination period; Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period.
General disorders Fatigue	19.0% 19/100 • SAE(s): during the entire study period (Days 0-182); Unsolicited AE(s): during the 90-day (Days 0-89) post-vaccination period; Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period.	15.2% 15/99 • SAE(s): during the entire study period (Days 0-182); Unsolicited AE(s): during the 90-day (Days 0-89) post-vaccination period; Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period.
General disorders Headache	24.0% 24/100 • SAE(s): during the entire study period (Days 0-182); Unsolicited AE(s): during the 90-day (Days 0-89) post-vaccination period; Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period.	21.2% 21/99 • SAE(s): during the entire study period (Days 0-182); Unsolicited AE(s): during the 90-day (Days 0-89) post-vaccination period; Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period.
General disorders Muscle aches	15.0% 15/100 • SAE(s): during the entire study period (Days 0-182); Unsolicited AE(s): during the 90-day (Days 0-89) post-vaccination period; Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period.	17.2% 17/99 • SAE(s): during the entire study period (Days 0-182); Unsolicited AE(s): during the 90-day (Days 0-89) post-vaccination period; Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period.

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