Trial Outcomes & Findings for Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Fluviral® (2012/2013 Season) in Adults (NCT NCT01626820)

Last Updated: 2018-09-07

Results Overview

Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

113 participants

Primary outcome timeframe

At Day 0 and Day 21

Results posted on

2018-09-07

Participant Flow

At least 50% of the subjects in Fluviral Adults and Fluviral Elderly Groups had not been previously immunized with influenza vaccine in the 2011/2012 season.

Participant milestones

Participant milestones
Measure	Fluviral Adults Group Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.	Fluviral Elderly Group Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm at Day 0
Overall Study STARTED	56	57
Overall Study COMPLETED	56	57
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Fluviral® (2012/2013 Season) in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluviral Adults Group n=56 Participants Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.	Fluviral Elderly Group n=57 Participants Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0	Total n=113 Participants Total of all reporting groups
Age, Continuous	39.80 Years STANDARD_DEVIATION 12.32 • n=5 Participants	68.30 Years STANDARD_DEVIATION 5.28 • n=7 Participants	54.18 Years STANDARD_DEVIATION 17.13 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 0 and Day 21

Population: Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Outcome measures

Outcome measures
Measure	Fluviral Adults Group n=56 Participants Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.	Fluviral Elderly Group n=56 Participants Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. [H1N1 strain, Day 0]	84.03 Titer Interval 56.69 to 124.57	40.48 Titer Interval 27.97 to 58.58
Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. [H1N1 strain, Day 21]	306.51 Titer Interval 237.33 to 395.86	159.02 Titer Interval 116.82 to 216.46
Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. [H3N2 strain, Day 0]	24.82 Titer Interval 17.1 to 36.04	37.33 Titer Interval 25.78 to 54.06
Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. [H3N2 strain, Day 21]	151.32 Titer Interval 109.35 to 209.39	167.04 Titer Interval 117.38 to 237.71
Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. [Yamagata strain, Day 0]	82.50 Titer Interval 60.43 to 112.63	65.58 Titer Interval 52.23 to 82.35
Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. [Yamagata strain, Day 21]	328.03 Titer Interval 253.7 to 424.14	234.79 Titer Interval 187.46 to 294.06

PRIMARY outcome

Timeframe: At Day 0 and Day 21

A seroprotected subject was defined as a subject with serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The influenza vaccine strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.

Outcome measures

Outcome measures
Measure	Fluviral Adults Group n=56 Participants Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.	Fluviral Elderly Group n=56 Participants Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. [H1N1 strain, Day 0]	43 Subjects	31 Subjects
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. [Yamagata strain, Day 0]	47 Subjects	46 Subjects
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. [H1N1 strain, Day 21]	56 Subjects	53 Subjects
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. [H3N2 strain, Day 0]	25 Subjects	32 Subjects
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. [H3N2 strain, Day 21]	51 Subjects	51 Subjects
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. [Yamagata strain, Day 21]	56 Subjects	56 Subjects

PRIMARY outcome

Timeframe: At Day 21

A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.

Outcome measures

Outcome measures
Measure	Fluviral Adults Group n=56 Participants Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.	Fluviral Elderly Group n=56 Participants Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. [H1N1 strain]	22 Subjects	22 Subjects
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. [Yamagata strain]	26 Subjects	27 Subjects
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. [H3N2 strain]	27 Subjects	23 Subjects

PRIMARY outcome

Timeframe: At Day 21

MGI was defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0).

Outcome measures

Outcome measures
Measure	Fluviral Adults Group n=56 Participants Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.	Fluviral Elderly Group n=56 Participants Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains. [H1N1 strain]	3.6 Fold increase Interval 2.5 to 5.4	3.9 Fold increase Interval 2.7 to 5.7
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains. [H3N2 strain]	6.1 Fold increase Interval 4.0 to 9.4	4.5 Fold increase Interval 3.0 to 6.8
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains. [Yamagata strain]	4.0 Fold increase Interval 2.9 to 5.5	3.6 Fold increase Interval 2.7 to 4.7

SECONDARY outcome

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

Population: Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.

Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling were defined as ecchymosis, induration, redness and swelling above 100 millimeters (mm).

Outcome measures

Outcome measures
Measure	Fluviral Adults Group n=56 Participants Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.	Fluviral Elderly Group n=57 Participants Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Induration	0 Subjects	0 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Induration	0 Subjects	0 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Pain	41 Subjects	12 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Redness	0 Subjects	0 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Swelling	0 Subjects	0 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Swelling	0 Subjects	0 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Ecchymosis	0 Subjects	0 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Ecchymosis	0 Subjects	0 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Pain	0 Subjects	0 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Redness	0 Subjects	1 Subjects

SECONDARY outcome

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

Population: Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed

Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and fever \[oral temperature ≥38.0 degrees Celsius (°C)\]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination, Any fever = oral temperature ≥38.0 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination

Outcome measures

Outcome measures
Measure	Fluviral Adults Group n=56 Participants Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.	Fluviral Elderly Group n=57 Participants Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Arthralgia	2 Subjects	2 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Arthralgia	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Arthralgia	2 Subjects	2 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fatigue	8 Subjects	7 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue	8 Subjects	7 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Gastrointestinal symptoms	3 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Myalgia	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Sweating	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Gastrointestinal symptoms	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Gastrointestinal symptoms	3 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Headache	10 Subjects	2 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Headache	10 Subjects	2 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Myalgia	8 Subjects	4 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Myalgia	8 Subjects	4 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Shivering	1 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Shivering	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Shivering	1 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Sweating	1 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Sweating	1 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fever	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fever	0 Subjects	0 Subjects

SECONDARY outcome

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

Population: Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	Fluviral Adults Group n=56 Participants Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.	Fluviral Elderly Group n=57 Participants Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).	11 Subjects	5 Subjects

SECONDARY outcome

Timeframe: During the entire study period (Day 0 - Day 20 after vaccination).

Population: Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.

SAEs assessed included medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	Fluviral Adults Group n=56 Participants Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.	Fluviral Elderly Group n=57 Participants Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Related SAE(s)	0 Subjects	0 Subjects
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Any SAE(s)	0 Subjects	0 Subjects

Adverse Events

Fluviral Adults Group

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Fluviral Elderly Group

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fluviral Adults Group n=56 participants at risk Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.	Fluviral Elderly Group n=57 participants at risk Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
General disorders Fatigue	14.3% 8/56 • Serious Adverse Events:During the entire study period i.e. Days 0-20 after vaccination; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	12.3% 7/57 • Serious Adverse Events:During the entire study period i.e. Days 0-20 after vaccination; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Gastointestinal symptoms	5.4% 3/56 • Serious Adverse Events:During the entire study period i.e. Days 0-20 after vaccination; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/57 • Serious Adverse Events:During the entire study period i.e. Days 0-20 after vaccination; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Headache	17.9% 10/56 • Serious Adverse Events:During the entire study period i.e. Days 0-20 after vaccination; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	3.5% 2/57 • Serious Adverse Events:During the entire study period i.e. Days 0-20 after vaccination; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Myalgia	14.3% 8/56 • Serious Adverse Events:During the entire study period i.e. Days 0-20 after vaccination; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	7.0% 4/57 • Serious Adverse Events:During the entire study period i.e. Days 0-20 after vaccination; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Pain	73.2% 41/56 • Serious Adverse Events:During the entire study period i.e. Days 0-20 after vaccination; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	21.1% 12/57 • Serious Adverse Events:During the entire study period i.e. Days 0-20 after vaccination; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.

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