Trial Outcomes & Findings for Study of GSK Biologicals' Influenza Vaccine Arepanrix™ in Japanese Adults 65 Years of Age or Older (NCT NCT01114620)
NCT ID: NCT01114620
Last Updated: 2019-11-05
Results Overview
Seroconversion (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
COMPLETED
PHASE4
50 participants
At Day 21
2019-11-05
Participant Flow
Participant milestones
| Measure |
Arepanrix Group
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of GSK Biologicals' Influenza Vaccine Arepanrix™ in Japanese Adults 65 Years of Age or Older
Baseline characteristics by cohort
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Age, Continuous
|
69.8 Years
STANDARD_DEVIATION 4.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese heritage
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
Seroconversion (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies
|
30 Participants
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
Seroprotection (SPR) was defined as the proportion of subjects with H1N1 reciprocal HI titers equal to or above (≥) 40 against the tested vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Seroprotected Subjects for HI Antibodies
|
32 Participants
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
|
10.2 Fold change
Interval 6.9 to 14.9
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Flu A/CAL/7/09, Day 0
|
12 Participants
|
|
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Flu A/CAL/7/09, Day 21
|
48 Participants
|
SECONDARY outcome
Timeframe: At Days 0 and 182Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.
Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Outcome measures
| Measure |
Arepanrix Group
n=49 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Flu A/CAL/7/09, Day 0
|
11 Participants
|
|
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Flu A/CAL/7/09, Day 182
|
40 Participants
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain
Flu A/CAL/7/09, Day 0
|
6.6 Titers
Interval 5.5 to 7.9
|
|
Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain
Flu A/CAL/7/09, Day 21
|
67.2 Titers
Interval 46.1 to 98.0
|
SECONDARY outcome
Timeframe: At Days 0 and 182Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Outcome measures
| Measure |
Arepanrix Group
n=49 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain
Flu A/CAL/7/09, Day 0
|
6.5 Titers
Interval 5.5 to 7.8
|
|
Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain
Flu A/CAL/7/09, Day 182
|
27.6 Titers
Interval 19.2 to 39.8
|
SECONDARY outcome
Timeframe: At Day 182Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.
SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Outcome measures
| Measure |
Arepanrix Group
n=49 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Seroconverted Subjects for HI Antibodies
|
19 Participants
|
SECONDARY outcome
Timeframe: At Days 0 and 182Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.
Seroprotection (SPR) was defined as the proportion of subjects with H1N1 reciprocal HI titers equal to or above (≥) 40 against the tested vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Outcome measures
| Measure |
Arepanrix Group
n=49 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Seroprotected Subjects for HI Antibodies
Flu A/CAL/7/09, Day 0
|
2 Participants
|
|
Number of Seroprotected Subjects for HI Antibodies
Flu A/CAL/7/09, Day 182
|
21 Participants
|
SECONDARY outcome
Timeframe: At Day 182Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.
GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Outcome measures
| Measure |
Arepanrix Group
n=49 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
GMFR for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
|
4.2 Fold change
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 days after vaccination were available.
Seropositivity cut-off values assessed were equal to or above (≥) 1:8 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Flu A/Neth/602/09, Day 0
|
19 Participants
|
|
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Flu A/Neth/602/09, Day 21
|
41 Participants
|
SECONDARY outcome
Timeframe: At Days 0 and 182Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.
Seropositivity cut-off values assessed were equal to or above (≥) 1:8 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
Outcome measures
| Measure |
Arepanrix Group
n=49 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Flu A/Neth/602/09, Day 0
|
18 Participants
|
|
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Flu A/Neth/602/09, Day 182
|
41 Participants
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 days after vaccination were available.
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:8. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
Flu A/Neth/602/09, Day 0
|
7.7 Titers
Interval 5.8 to 10.1
|
|
Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
Flu A/Neth/602/09, Day 21
|
29.3 Titers
Interval 18.6 to 46.0
|
SECONDARY outcome
Timeframe: At Days 0 and 182Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:8. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
Outcome measures
| Measure |
Arepanrix Group
n=49 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
Flu A/Neth/602/09, Day 0
|
7.5 Titers
Interval 5.7 to 9.9
|
|
Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
Flu A/Neth/602/09, Day 182
|
20.4 Titers
Interval 14.4 to 28.7
|
SECONDARY outcome
Timeframe: At Day 21Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 days after vaccination were available.
VRR for microneutralization titers was defined as the proportion of vaccinees with at least a 4-fold increase in post-vaccination reciprocal titer relative to Day 0. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Subjects With Vaccine Response Rate (VRR) for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
|
20 Participants
|
SECONDARY outcome
Timeframe: At Day 182Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.
VRR for microneutralization titers was defined as the proportion of vaccinees with at least a 4-fold increase in post-vaccination reciprocal titer relative to Day 0. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
Outcome measures
| Measure |
Arepanrix Group
n=49 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Subjects With VRR for Neutralizing Antibodies Against Flu A/Netherlands/602/2009 Strain of Influenza Disease
|
15 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain
|
33 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness
|
8 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling
|
5 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
The number of days with any solicited local symptoms reported during the solicited post-vaccination period.
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Days With Solicited Local Symptoms
Pain
|
3.0 Days
Interval 2.0 to 4.0
|
|
Number of Days With Solicited Local Symptoms
Redness
|
3.0 Days
Interval 1.5 to 6.0
|
|
Number of Days With Solicited Local Symptoms
Swelling
|
2.0 Days
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
Assessed solicited general symptoms were Fatigue, Headache, Joint pain at other location, Muscle aches, Shivering, Sweating and Fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C to ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Joint pain
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Joint pain
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Joint pain
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Muscle aches
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Muscle aches
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Muscle aches
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Sweating
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Sweating
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
The number of days with any solicited general symptoms reported during the solicited post-vaccination period.
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Days With Solicited General Symptoms
Fatigue
|
1.0 Days
Interval 1.0 to 3.0
|
|
Number of Days With Solicited General Symptoms
Headache
|
1.0 Days
Interval 1.0 to 3.0
|
|
Number of Days With Solicited General Symptoms
Joint pain
|
1.0 Days
Interval 1.0 to 1.0
|
|
Number of Days With Solicited General Symptoms
Muscle aches
|
3.0 Days
Interval 2.0 to 4.0
|
|
Number of Days With Solicited General Symptoms
Sweating
|
1.0 Days
Interval 1.0 to 1.0
|
|
Number of Days With Solicited General Symptoms
Shivering
|
1.0 Days
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: During the 21-day (Days 0-20) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Subjects With Medically Attended AEs (MAEs)
|
1 Participants
|
SECONDARY outcome
Timeframe: During the 42-day (Days 0-41) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Subjects With MAEs
|
7 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 up to Day 182)Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 0 and Day 7Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
Among hematological and biochemical parameters assessed were alanine aminotransferase (ALAT), albumin, alkaline phosphatase (AP), aspartate aminotransferase (ASAT), basophils, total bilirubin, bilirubin conjugated/direct, cholesterol, chloride, creatine, creatine kinase (CK), eosinophils, gamma-glutamyl transpeptidase (GGT), hematocrit, hemoglobin, potassium, lactate dyhydrogenase (LDH), lymphocytes, monocytes, sodium, neutrophils, platelets, protein, red blood cells, urate/uric acid, blood urea nitrogen (BUN) and white blood cells. Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter.
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Monocytes Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
ALAT Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
ALAT Below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
LDH Within, Day 7
|
49 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
LDH Above, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
LDH Above, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Lymphocytes Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Lymphocytes Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Lymphocytes Below, Day 0
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Lymphocytes Below, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Lymphocytes Within, Day 0
|
49 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Lymphocytes Within, Day 7
|
50 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Lymphocytes Above, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Lymphocytes Above, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Monocytes Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Monocytes Below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Monocytes Below, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Monocytes Within, Day 0
|
47 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Monocytes Within, Day 7
|
47 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Monocytes Above, Day 0
|
3 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Monocytes Above, Day 7
|
3 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Sodium Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Sodium Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Sodium Below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Sodium Below, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Sodium Within, Day 0
|
50 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Sodium Within, Day 7
|
50 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Sodium Above, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Sodium Above, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Neutrophils Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Neutrophils Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
ALAT Below, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
ALAT Within, Day 0
|
49 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
ALAT Within, Day 7
|
50 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
ALAT Above, Day 0
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
ALAT Above, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Neutrophils Below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Neutrophils Below, Day 7
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Neutrophils Within, Day 0
|
47 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Neutrophils Within, Day 7
|
49 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Neutrophils Above, Day 0
|
3 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Neutrophils Above, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Platelets Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Platelets Unknown, Day 7
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Platelets Below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Platelets Below, Day 7
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Platelets Within, Day 0
|
50 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Platelets Within, Day 7
|
48 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Platelets Above, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Platelets Above, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Protein Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Protein Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Protein Below, Day 0
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Protein Below, Day 7
|
3 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Protein Within, Day 0
|
45 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Protein Within, Day 7
|
46 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Protein Above, Day 0
|
3 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Protein Above, Day 7
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Red Blood Cells Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Red Blood Cells Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Red Blood Cells Below, Day 0
|
4 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Red Blood Cells Below, Day 7
|
4 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Red Blood Cells Within, Day 0
|
46 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Red Blood Cells Within, Day 7
|
46 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Red Blood Cells Above, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Red Blood Cells Above, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Urate/Uric acid Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Urate/Uric acid Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Urate/Uric acid Below, Day 0
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Urate/Uric acid Below, Day 7
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Urate/Uric acid Within, Day 0
|
45 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Urate/Uric acid Within, Day 7
|
45 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Urate/Uric acid Above, Day 0
|
4 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Urate/Uric acid Above, Day 7
|
4 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
BUN Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
BUN Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
BUN Below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
BUN Below, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
BUN Within, Day 0
|
44 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
BUN Within, Day 7
|
44 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
BUN Above, Day 0
|
6 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
BUN Above, Day 7
|
6 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
White Blood Cells Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
White Blood Cells Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
White Blood Cells Below, Day 0
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
White Blood Cells Below, Day 7
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
White Blood Cells Within, Day 0
|
46 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
White Blood Cells Within, Day 7
|
48 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
White Blood Cells Above, Day 0
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
White Blood Cells Above, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Albumin Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Albumin Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Albumin Below, Day 0
|
4 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Albumin Below, Day 7
|
6 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Albumin Within, Day 0
|
46 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Albumin Within, Day 7
|
44 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Albumin Above, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Albumin Above, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
AP Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
AP Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
AP Below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
AP Below, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
AP Within, Day 0
|
48 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
AP Within, Day 7
|
48 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
AP Above, Day 0
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
AP Above, Day 7
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
ASAT Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
ALAT Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
ASAT Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
ASAT Below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
ASAT Below, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
ASAT Within, Day 0
|
49 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
ASAT Within, Day 7
|
50 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
ASAT Above, Day 0
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
ASAT Above, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Basophils Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Basophils Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Basophils Below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Basophils Below, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Basophils Within, Day 0
|
50 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Basophils Within, Day 7
|
49 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Basophils Above, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Basophils Above, Day 7
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Total Bilirubin Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Total Bilirubin Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Total Bilirubin Below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Total Bilirubin Below, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Total Bilirubin Within, Day 0
|
50 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Total Bilirubin Within, Day 7
|
50 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Total Bilirubin Above, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Total Bilirubin Above, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Bilirubin Conjugated/Direct Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Bilirubin Conjugated/Direct Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Bilirubin Conjugated/Direct Below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Bilirubin Conjugated/Direct Below, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Bilirubin Conjugated/Direct Within, Day 0
|
50 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Bilirubin Conjugated/Direct Within, Day 7
|
50 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Bilirubin Conjugated/Direct Above, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Bilirubin Conjugated/Direct Above, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Cholesterol Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Cholesterol Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Cholesterol Below, Day 0
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Cholesterol Below, Day 7
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Cholesterol Within, Day 0
|
31 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Cholesterol Within, Day 7
|
36 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Cholesterol Above, Day 0
|
17 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Cholesterol Above, Day 7
|
12 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Chloride Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Chloride Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Chloride Below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Chloride Below, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Chloride Within, Day 0
|
46 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Chloride Within, Day 7
|
44 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Chloride Above, Day 0
|
4 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Chloride Above, Day 7
|
6 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Creatine Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Creatine Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Creatine Below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Creatine Below, Day 7
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Creatine Within, Day 0
|
44 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Creatine Within, Day 7
|
43 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Creatine Above, Day 0
|
6 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Creatine Above, Day 7
|
6 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
CK Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
CK Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
CK Below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
CK Below, Day 7
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
CK Within, Day 0
|
45 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
CK Within, Day 7
|
43 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
CK Above, Day 0
|
5 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
CK Above, Day 7
|
6 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Eosinophils Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Eosinophils Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Eosinophils Below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Eosinophils Below, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Eosinophils Within, Day 0
|
48 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Eosinophils Within, Day 7
|
48 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Eosinophils Above, Day 0
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Eosinophils Above, Day 7
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
GGT Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
GGT Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
GGT Below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
GGT Below, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
GGT Within, Day 0
|
41 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
GGT Within, Day 7
|
41 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
GGT Above, Day 0
|
9 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
GGT Above, Day 7
|
9 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Hematocrit Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Hematocrit Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Hematocrit Below, Day 0
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Hematocrit Below, Day 7
|
3 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Hematocrit Within, Day 0
|
46 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Hematocrit Within, Day 7
|
47 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Hematocrit Above, Day 0
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Hematocrit Above, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Hemoglobin Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Hemoglobin Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Hemoglobin Below, Day 0
|
7 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Hemoglobin Below, Day 7
|
8 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Hemoglobin Within, Day 0
|
43 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Hemoglobin Within, Day 7
|
42 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Hemoglobin Above, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Hemoglobin Above, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Potassium Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Potassium Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Potassium Below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Potassium Below, Day 7
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Potassium Within, Day 0
|
49 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Potassium Within, Day 7
|
48 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Potassium Above, Day 0
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Potassium Above, Day 7
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
LDH Unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
LDH Unknown, Day 7
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
LDH Below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
LDH Below, Day 7
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
LDH Within, Day 0
|
50 Participants
|
SECONDARY outcome
Timeframe: At Day 0 and Day 7Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
Among assessed urine sampling parameters were glucose, protein, red blood cells and urobilinogen.
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Subjects With Abnormal Urine Sampling Parameters
Glucose Negative, Day 0
|
49 Participants
|
|
Number of Subjects With Abnormal Urine Sampling Parameters
Glucose Positive, Day 0
|
1 Participants
|
|
Number of Subjects With Abnormal Urine Sampling Parameters
Glucose Negative, Day 7
|
45 Participants
|
|
Number of Subjects With Abnormal Urine Sampling Parameters
Glucose Positive, Day 7
|
5 Participants
|
|
Number of Subjects With Abnormal Urine Sampling Parameters
Protein Negative, Day 0
|
49 Participants
|
|
Number of Subjects With Abnormal Urine Sampling Parameters
Protein Positive, Day 0
|
1 Participants
|
|
Number of Subjects With Abnormal Urine Sampling Parameters
Protein Negative, Day 7
|
50 Participants
|
|
Number of Subjects With Abnormal Urine Sampling Parameters
Protein Positive, Day 7
|
0 Participants
|
|
Number of Subjects With Abnormal Urine Sampling Parameters
Red Blood Cells Negative, Day 0
|
45 Participants
|
|
Number of Subjects With Abnormal Urine Sampling Parameters
Red Blood Cells Positive, Day 0
|
5 Participants
|
|
Number of Subjects With Abnormal Urine Sampling Parameters
Red Blood Cells Negative, Day 7
|
43 Participants
|
|
Number of Subjects With Abnormal Urine Sampling Parameters
Red Blood Cells Positive, Day 7
|
7 Participants
|
|
Number of Subjects With Abnormal Urine Sampling Parameters
Urobilinogen Negative, Day 0
|
49 Participants
|
|
Number of Subjects With Abnormal Urine Sampling Parameters
Urobilinogen Positive, Day 0
|
1 Participants
|
|
Number of Subjects With Abnormal Urine Sampling Parameters
Urobilinogen Negative, Day 7
|
50 Participants
|
|
Number of Subjects With Abnormal Urine Sampling Parameters
Urobilinogen Positive, Day 7
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 21-day (Days 0-20) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
An unsolicited AE covers 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 and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Any AE(s)
|
4 Participants
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Grade 3 AE(s)
|
0 Participants
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Related AE(s)
|
1 Participants
|
SECONDARY outcome
Timeframe: During the 42-day (Days 0-41) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
An unsolicited AE covers 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 and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Subjects With Unsolicited AEs
Any AE(s)
|
10 Subjects
|
|
Number of Subjects With Unsolicited AEs
Grade 3 AE(s)
|
2 Subjects
|
|
Number of Subjects With Unsolicited AEs
Related AE(s)
|
1 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 up to Day 182)Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Arepanrix Group
n=50 Participants
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
4 Participants
|
Adverse Events
Arepanrix Group
Serious adverse events
| Measure |
Arepanrix Group
n=50 participants at risk
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
Eye disorders
Cataract
|
2.0%
1/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 42-day (Days 0-41) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 182).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant recurrent
|
2.0%
1/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 42-day (Days 0-41) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 182).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
2.0%
1/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 42-day (Days 0-41) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 182).
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
1/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 42-day (Days 0-41) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 182).
|
Other adverse events
| Measure |
Arepanrix Group
n=50 participants at risk
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
|
|---|---|
|
General disorders
Pain
|
66.0%
33/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 42-day (Days 0-41) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 182).
|
|
General disorders
Redness
|
16.0%
8/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 42-day (Days 0-41) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 182).
|
|
General disorders
Swelling
|
10.0%
5/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 42-day (Days 0-41) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 182).
|
|
General disorders
Fatigue
|
20.0%
10/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 42-day (Days 0-41) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 182).
|
|
General disorders
Headache
|
14.0%
7/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 42-day (Days 0-41) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 182).
|
|
General disorders
Muscle aches
|
20.0%
10/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 42-day (Days 0-41) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 182).
|
Additional Information
GSK Response Center
GlaxoSmithKline
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