Trial Outcomes & Findings for Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations (NCT NCT00633074)
NCT ID: NCT00633074
Last Updated: 2018-06-08
Results Overview
Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
720 participants
Primary outcome timeframe
Days 0 and 21
Results posted on
2018-06-08
Participant Flow
Participant milestones
| Measure |
Thiomersal-free FluAS25 Adjuvanted Vaccine Group
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
|
Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
|
|---|---|---|
|
Overall Study
STARTED
|
360
|
360
|
|
Overall Study
COMPLETED
|
359
|
360
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Thiomersal-free FluAS25 Adjuvanted Vaccine Group
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
|
Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations
Baseline characteristics by cohort
| Measure |
Thiomersal-free FluAS25 Adjuvanted Vaccine Group
n=360 Participants
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
|
Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group
n=360 Participants
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
|
Total
n=720 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 Years
STANDARD_DEVIATION 5.02 • n=99 Participants
|
71.7 Years
STANDARD_DEVIATION 4.88 • n=107 Participants
|
71.85 Years
STANDARD_DEVIATION 4.95 • n=206 Participants
|
|
Sex: Female, Male
Female
|
263 Participants
n=99 Participants
|
257 Participants
n=107 Participants
|
520 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
200 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Days 0 and 21Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Outcome measures
| Measure |
Thiomersal-free FluAS25 Adjuvanted Vaccine Group
n=357 Participants
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
|
Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group
n=360 Participants
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
|
|---|---|---|
|
Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
A/Solomon Islands [Day 0]
|
6.0 Titer
Interval 5.7 to 6.4
|
6.0 Titer
Interval 5.7 to 6.3
|
|
Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
A/Solomon Islands [Day 21]
|
86.5 Titer
Interval 75.8 to 98.8
|
93.1 Titer
Interval 80.5 to 107.6
|
|
Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
A/Wisconsin [Day 0]
|
15.9 Titer
Interval 13.9 to 18.1
|
14.9 Titer
Interval 13.1 to 17.0
|
|
Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
A/Wisconsin [Day 21]
|
613.2 Titer
Interval 540.1 to 696.1
|
519.3 Titer
Interval 451.5 to 597.3
|
|
Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
B/Malaysia [Day 0]
|
13.2 Titer
Interval 11.9 to 14.7
|
13.0 Titer
Interval 11.7 to 14.5
|
|
Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
B/Malaysia [Day 21]
|
287.5 Titer
Interval 255.9 to 323.1
|
264.9 Titer
Interval 235.5 to 297.9
|
SECONDARY outcome
Timeframe: Days 0 and 21Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Outcome measures
| Measure |
Thiomersal-free FluAS25 Adjuvanted Vaccine Group
n=357 Participants
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
|
Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group
n=360 Participants
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
|
|---|---|---|
|
Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains
A/Solomon Islands [Day 0]
|
67 Subjects
|
62 Subjects
|
|
Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains
A/Solomon Islands [Day 21]
|
342 Subjects
|
338 Subjects
|
|
Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains
A/Wisconsin [Day 0]
|
209 Subjects
|
199 Subjects
|
|
Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains
A/Wisconsin [Day 21]
|
357 Subjects
|
359 Subjects
|
|
Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains
B/Malaysia [Day 0]
|
215 Subjects
|
208 Subjects
|
|
Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains
B/Malaysia [Day 21]
|
355 Subjects
|
357 Subjects
|
SECONDARY outcome
Timeframe: Day 21Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Outcome measures
| Measure |
Thiomersal-free FluAS25 Adjuvanted Vaccine Group
n=357 Participants
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
|
Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group
n=360 Participants
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
|
|---|---|---|
|
Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains
A/Solomon Islands
|
278 Subjects
|
281 Subjects
|
|
Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains
A/Wisconsin
|
336 Subjects
|
337 Subjects
|
|
Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains
B/Malaysia
|
332 Subjects
|
335 Subjects
|
SECONDARY outcome
Timeframe: Day 21Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Outcome measures
| Measure |
Thiomersal-free FluAS25 Adjuvanted Vaccine Group
n=357 Participants
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
|
Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group
n=360 Participants
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
|
|---|---|---|
|
HI Antibody Seroconversion Factors
A/Solomon Islands
|
14.3 Fold increase
Interval 12.6 to 16.3
|
15.6 Fold increase
Interval 13.5 to 18.1
|
|
HI Antibody Seroconversion Factors
A/Wisconsin
|
38.7 Fold increase
Interval 33.6 to 44.5
|
34.8 Fold increase
Interval 30.0 to 40.3
|
|
HI Antibody Seroconversion Factors
B/Malaysia
|
21.8 Fold increase
Interval 19.3 to 24.6
|
20.3 Fold increase
Interval 18.0 to 22.9
|
SECONDARY outcome
Timeframe: Days 0 and 21Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
A seroprotected subject was defined as a suject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Outcome measures
| Measure |
Thiomersal-free FluAS25 Adjuvanted Vaccine Group
n=357 Participants
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
|
Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group
n=360 Participants
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
|
|---|---|---|
|
Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains
B/Malaysia [Day 21]
|
349 Subjects
|
351 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains
A/Solomon Islands [Day 0]
|
10 Subjects
|
6 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains
A/Solomon Islands [Day 21]
|
280 Subjects
|
287 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains
A/Wisconsin [Day 0]
|
112 Subjects
|
97 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains
A/Wisconsin [Day 21]
|
350 Subjects
|
348 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains
B/Malaysia [Day 0]
|
74 Subjects
|
75 Subjects
|
SECONDARY outcome
Timeframe: During a 7-day period after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.
Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
Outcome measures
| Measure |
Thiomersal-free FluAS25 Adjuvanted Vaccine Group
n=360 Participants
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
|
Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group
n=360 Participants
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
|
|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any ecchymosis
|
7 Subjects
|
6 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
Any pain
|
237 Subjects
|
246 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 pain
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any redness
|
152 Subjects
|
161 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 redness
|
10 Subjects
|
12 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any swelling
|
74 Subjects
|
90 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 swelling
|
1 Subjects
|
4 Subjects
|
SECONDARY outcome
Timeframe: During a 7-day period after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.
Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.
Outcome measures
| Measure |
Thiomersal-free FluAS25 Adjuvanted Vaccine Group
n=237 Participants
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
|
Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group
n=246 Participants
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
|
|---|---|---|
|
Duration of Solicited Local Symptoms
Ecchymosis (N= 7; 6)
|
4.0 Days
Interval 1.0 to 7.0
|
3.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local Symptoms
Pain (N= 237; 246)
|
3.0 Days
Interval 1.0 to 7.0
|
3.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local Symptoms
Redness (N= 152; 161)
|
3.0 Days
Interval 1.0 to 7.0
|
4.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local Symptoms
Swelling (N= 74; 90)
|
3.5 Days
Interval 1.0 to 7.0
|
3.5 Days
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: During a 7-day period after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Thiomersal-free FluAS25 Adjuvanted Vaccine Group
n=360 Participants
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
|
Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group
n=360 Participants
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any arthralgia
|
78 Subjects
|
87 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 arthralgia
|
1 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related arthralgia
|
75 Subjects
|
85 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any fatigue
|
139 Subjects
|
143 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 fatigue
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related fatigue
|
139 Subjects
|
141 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any headache
|
109 Subjects
|
107 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 headache
|
3 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related headache
|
109 Subjects
|
105 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any myalgia
|
111 Subjects
|
101 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 myalgia
|
1 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related myalgia
|
111 Subjects
|
99 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any nausea
|
38 Subjects
|
43 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 nausea
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related nausea
|
37 Subjects
|
42 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any shivering
|
45 Subjects
|
43 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 shivering
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related shivering
|
45 Subjects
|
43 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any fever
|
34 Subjects
|
38 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 fever
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related fever
|
34 Subjects
|
38 Subjects
|
SECONDARY outcome
Timeframe: During a 7-day period after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.
Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
Outcome measures
| Measure |
Thiomersal-free FluAS25 Adjuvanted Vaccine Group
n=139 Participants
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
|
Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group
n=143 Participants
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
|
|---|---|---|
|
Duration of Solicited General Symptoms
Shivering (N= 45; 43)
|
1.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited General Symptoms
Fever (N= 26; 25)
|
1.0 Days
Interval 1.0 to 1.0
|
1.0 Days
Interval 1.0 to 4.0
|
|
Duration of Solicited General Symptoms
Arthralgia (N= 78; 87)
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited General Symptoms
Fatigue (N= 139; 143)
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited General Symptoms
Headache (N= 109; 107)
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited General Symptoms
Myalgia (N= 111; 101)
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited General Symptoms
Nausea (N= 38; 43)
|
1.0 Days
Interval 1.0 to 6.0
|
1.0 Days
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: During a 21-day period after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.
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.
Outcome measures
| Measure |
Thiomersal-free FluAS25 Adjuvanted Vaccine Group
n=360 Participants
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
|
Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group
n=360 Participants
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AEs
|
83 Subjects
|
71 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AEs
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AEs
|
61 Subjects
|
53 Subjects
|
SECONDARY outcome
Timeframe: During a 21-day period after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.
Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit.
Outcome measures
| Measure |
Thiomersal-free FluAS25 Adjuvanted Vaccine Group
n=360 Participants
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
|
Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group
n=360 Participants
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Any MSCs
|
9 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Grade 3 MSCs
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Related MSCs
|
1 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (up to Day 21)Population: The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.
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.
Outcome measures
| Measure |
Thiomersal-free FluAS25 Adjuvanted Vaccine Group
n=360 Participants
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
|
Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group
n=360 Participants
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
|
|---|---|---|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Any SAEs
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Related SAEs
|
0 Subjects
|
0 Subjects
|
Adverse Events
Thiomersal-free FluAS25 Adjuvanted Vaccine Group
Serious events: 3 serious events
Other events: 303 other events
Deaths: 0 deaths
Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group
Serious events: 0 serious events
Other events: 321 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Thiomersal-free FluAS25 Adjuvanted Vaccine Group
n=360 participants at risk
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
|
Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group
n=360 participants at risk
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
|
|---|---|---|
|
Cardiac disorders
Arterial fibrillation
|
0.28%
1/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
0.00%
0/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
Vascular disorders
Circulatory collapse
|
0.28%
1/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
0.00%
0/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
Cardiac disorders
Myocardial infarction
|
0.28%
1/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
0.00%
0/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.28%
1/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
0.00%
0/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
Other adverse events
| Measure |
Thiomersal-free FluAS25 Adjuvanted Vaccine Group
n=360 participants at risk
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
|
Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group
n=360 participants at risk
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
|
|---|---|---|
|
General disorders
Pain
|
65.8%
237/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
68.3%
246/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Redness
|
42.2%
152/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
44.7%
161/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Swelling
|
20.6%
74/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
25.0%
90/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Arthralgia
|
21.7%
78/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
24.2%
87/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Fatigue
|
38.6%
139/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
39.7%
143/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Headache
|
30.3%
109/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
29.7%
107/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Myalgia
|
30.8%
111/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
28.1%
101/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Nausea
|
10.6%
38/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
11.9%
43/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Shivering
|
12.5%
45/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
11.9%
43/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Fever
|
9.4%
34/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
10.6%
38/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Injection site pruritus
|
9.4%
34/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
8.3%
30/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Injection site induration
|
6.1%
22/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
5.3%
19/360 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
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