Trial Outcomes & Findings for A Study to Evaluate Safety and Immunogenicity of Trivalent Influenza Vaccine, Formulation 2015 Southern Hemisphere, When Administered to Healthy Adult Subjects. (NCT NCT02427750)
NCT ID: NCT02427750
Last Updated: 2015-10-19
Results Overview
Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm\^2 against each of the three vaccine strains, three weeks after receiving one dose of TIV. The related European Committee for Medicinal Products for Human Use (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm\^2 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
126 participants
Primary outcome timeframe
Day 1 and Day 22 post vaccination
Results posted on
2015-10-19
Participant Flow
Participants were enrolled from one study center in Brazil.
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
TIV (18 to ≤ 60 Years)
Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
|
TIV (≥ 61 Years)
Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
63
|
|
Overall Study
COMPLETED
|
63
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Safety and Immunogenicity of Trivalent Influenza Vaccine, Formulation 2015 Southern Hemisphere, When Administered to Healthy Adult Subjects.
Baseline characteristics by cohort
| Measure |
TIV (18 to ≤ 60 Years)
n=63 Participants
Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
|
TIV (≥ 61 Years)
n=63 Participants
Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.1 years
STANDARD_DEVIATION 11.0 • n=39 Participants
|
69.3 years
STANDARD_DEVIATION 6.9 • n=41 Participants
|
50.7 years
STANDARD_DEVIATION 20.8 • n=35 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=39 Participants
|
52 Participants
n=41 Participants
|
107 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 22 post vaccinationPopulation: The analysis was performed on the per-protocol population (PP).
Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm\^2 against each of the three vaccine strains, three weeks after receiving one dose of TIV. The related European Committee for Medicinal Products for Human Use (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm\^2 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years.
Outcome measures
| Measure |
TIV (18 to ≤ 60 Years)
n=63 Participants
Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
|
TIV (≥ 61 Years)
n=62 Participants
Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
|
|---|---|---|
|
Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm^2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
B strains (Day 22)
|
94 Percentages of subjects
Interval 85.0 to 98.0
|
84 Percentages of subjects
Interval 72.0 to 92.0
|
|
Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm^2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
A/H1N1 (Day 1)
|
62 Percentages of subjects
Interval 49.0 to 74.0
|
52 Percentages of subjects
Interval 39.0 to 65.0
|
|
Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm^2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
A/H3N2 (Day 1)
|
51 Percentages of subjects
Interval 38.0 to 64.0
|
40 Percentages of subjects
Interval 28.0 to 54.0
|
|
Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm^2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
B strains (Day 1)
|
71 Percentages of subjects
Interval 59.0 to 82.0
|
61 Percentages of subjects
Interval 48.0 to 73.0
|
|
Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm^2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
A/H1N1 (Day 22)
|
98 Percentages of subjects
Interval 91.0 to 100.0
|
63 Percentages of subjects
Interval 50.0 to 75.0
|
|
Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm^2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
A/H3N2 (Day 22)
|
84 Percentages of subjects
Interval 73.0 to 92.0
|
73 Percentages of subjects
Interval 60.0 to 83.0
|
PRIMARY outcome
Timeframe: Day 22 post vaccinationPopulation: The analysis was performed on the PP dataset
Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains, three weeks after receiving one dose of TIV. Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤ 4mm\^2 achieving a post vaccination SRH area ≥ 25mm\^2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area \> 4mm\^2 achieving at least 50% increase in post vaccination SRH area. The related European (CHMP) criterion for the assessment of immunogenicity is met if \>40% for adults aged 18 to ≤60 years and \>30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination SRH areas.
Outcome measures
| Measure |
TIV (18 to ≤ 60 Years)
n=63 Participants
Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
|
TIV (≥ 61 Years)
n=62 Participants
Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
|
|---|---|---|
|
Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
A/H1N1
|
46 Percentages of subjects
Interval 33.0 to 59.0
|
39 Percentages of subjects
Interval 27.0 to 52.0
|
|
Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
A/H3N2
|
49 Percentages of subjects
Interval 36.0 to 62.0
|
47 Percentages of subjects
Interval 34.0 to 60.0
|
|
Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
B strains
|
48 Percentages of subjects
Interval 35.0 to 61.0
|
32 Percentages of subjects
Interval 21.0 to 45.0
|
PRIMARY outcome
Timeframe: Day 22/ Day1 post vaccinationPopulation: The analysis was performed on the PP dataset.
The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \>2.5 for adults aged 18 to ≤60 years and \> 2.0 in for subjects aged ≥61 years.
Outcome measures
| Measure |
TIV (18 to ≤ 60 Years)
n=63 Participants
Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
|
TIV (≥ 61 Years)
n=62 Participants
Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
|
|---|---|---|
|
Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Area (GMAs), After One Dose of TIV.
A/H1N1
|
2.3 Ratio
Interval 1.79 to 2.95
|
1.58 Ratio
Interval 1.39 to 1.81
|
|
Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Area (GMAs), After One Dose of TIV.
A/H3N2
|
2.48 Ratio
Interval 1.8 to 3.42
|
2.18 Ratio
Interval 1.59 to 2.99
|
|
Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Area (GMAs), After One Dose of TIV.
B strains
|
2.28 Ratio
Interval 1.75 to 2.98
|
1.72 Ratio
Interval 1.35 to 2.17
|
PRIMARY outcome
Timeframe: Day 1 and Day 22 post vaccinationPopulation: The analysis was performed on the PP dataset.
Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years.
Outcome measures
| Measure |
TIV (18 to ≤ 60 Years)
n=63 Participants
Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
|
TIV (≥ 61 Years)
n=62 Participants
Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
|
|---|---|---|
|
Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
A/H3N2 (Day 22)
|
100 Percentages of Subjects
Interval 94.0 to 100.0
|
100 Percentages of Subjects
Interval 94.0 to 100.0
|
|
Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
A/H1N1 (Day 1)
|
89 Percentages of Subjects
Interval 78.0 to 95.0
|
90 Percentages of Subjects
Interval 80.0 to 96.0
|
|
Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
A/H3N2 (Day 1)
|
79 Percentages of Subjects
Interval 67.0 to 89.0
|
87 Percentages of Subjects
Interval 76.0 to 94.0
|
|
Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
B strains (Day 1)
|
46 Percentages of Subjects
Interval 33.0 to 59.0
|
40 Percentages of Subjects
Interval 28.0 to 54.0
|
|
Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
A/H1N1 (Day 22)
|
100 Percentages of Subjects
Interval 94.0 to 100.0
|
98 Percentages of Subjects
Interval 91.0 to 100.0
|
|
Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.
B strains (Day 22)
|
92 Percentages of Subjects
Interval 82.0 to 97.0
|
60 Percentages of Subjects
Interval 46.0 to 72.0
|
PRIMARY outcome
Timeframe: Day 22 post vaccinationPopulation: The analysis was performed on the PP dataset.
Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIV. Seroconversion is defined as percentage of subjects with a pre vaccination HI titer \<10 and a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 and at least a 4-fold increase in post vaccination HI antibody titers. The related European (CHMP) criterion for the assessment of immunogenicity is met if \>40% for adults aged 18 to ≤60 years and \>30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers.
Outcome measures
| Measure |
TIV (18 to ≤ 60 Years)
n=63 Participants
Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
|
TIV (≥ 61 Years)
n=62 Participants
Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
|
|---|---|---|
|
Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV.
A/H1N1
|
44 Percentages of Subjects
Interval 32.0 to 58.0
|
23 Percentages of Subjects
Interval 13.0 to 35.0
|
|
Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV.
A/H3N2
|
56 Percentages of Subjects
Interval 42.0 to 68.0
|
55 Percentages of Subjects
Interval 42.0 to 68.0
|
|
Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV.
B strains
|
44 Percentages of Subjects
Interval 32.0 to 58.0
|
13 Percentages of Subjects
Interval 6.0 to 24.0
|
PRIMARY outcome
Timeframe: Day 22/Day 1 post vaccinationPopulation: The analysis was performed on the PP dataset.
The antibody responses following one vaccination of TIV were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \>2.5 for adults aged 18 to ≤60 years and \> 2.0 for subjects aged ≥61 years.
Outcome measures
| Measure |
TIV (18 to ≤ 60 Years)
n=63 Participants
Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
|
TIV (≥ 61 Years)
n=62 Participants
Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
|
|---|---|---|
|
GMR of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV.
A/H1N1
|
3.96 Ratio
Interval 2.76 to 5.67
|
2.01 Ratio
Interval 1.68 to 2.4
|
|
GMR of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV.
A/H3N2
|
6.78 Ratio
Interval 4.57 to 10.0
|
5 Ratio
Interval 3.65 to 6.86
|
|
GMR of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV.
B strains
|
3.57 Ratio
Interval 2.68 to 4.74
|
1.68 Ratio
Interval 1.39 to 2.03
|
PRIMARY outcome
Timeframe: Day 1 to Day 4 post vaccination (including 30 mins)Population: Analysis was done on the solicited safety set population i.e. all subjects who have post vaccination solicited local and systemic adverse event data.
The number of adult and elderly subjects reporting solicited local and systemic AEs and other solicited AEs after receiving one dose of TIV are reported.
Outcome measures
| Measure |
TIV (18 to ≤ 60 Years)
n=63 Participants
Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
|
TIV (≥ 61 Years)
n=63 Participants
Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
|
|---|---|---|
|
Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.
Arthralgia
|
3 Number of Subjects
|
5 Number of Subjects
|
|
Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.
Local AEs (Type I)
|
16 Number of Subjects
|
19 Number of Subjects
|
|
Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.
Injection-site induration (Type I)
|
4 Number of Subjects
|
8 Number of Subjects
|
|
Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.
Injection-site erythema (Type I)
|
4 Number of Subjects
|
7 Number of Subjects
|
|
Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.
Injection-site ecchymosis (Type I)
|
1 Number of Subjects
|
1 Number of Subjects
|
|
Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.
Injection-site pain
|
14 Number of Subjects
|
9 Number of Subjects
|
|
Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.
Systemic AEs (Type I)
|
18 Number of Subjects
|
16 Number of Subjects
|
|
Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.
Shivering/chills
|
2 Number of Subjects
|
4 Number of Subjects
|
|
Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.
Myalgia
|
6 Number of Subjects
|
4 Number of Subjects
|
|
Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.
Headache
|
12 Number of Subjects
|
8 Number of Subjects
|
|
Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.
Fatigue
|
6 Number of Subjects
|
4 Number of Subjects
|
|
Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.
Malaise
|
1 Number of Subjects
|
2 Number of Subjects
|
|
Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.
Fever ≥38.0°C
|
2 Number of Subjects
|
2 Number of Subjects
|
|
Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.
Other- Treatment of pain and|or fever
|
1 Number of Subjects
|
9 Number of Subjects
|
|
Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.
Other- Prevention of pain and|or fever
|
0 Number of Subjects
|
3 Number of Subjects
|
PRIMARY outcome
Timeframe: Day 1 to Day 4 post vaccinationPopulation: Analysis was done on the unsolicited safety set population i.e., all subjects who have post vaccination unsolicited adverse event data.
The number of subjects in both age groups reporting any unsolicited AEs between Day 1 to Day 4 after receiving one dose of TIV.
Outcome measures
| Measure |
TIV (18 to ≤ 60 Years)
n=63 Participants
Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
|
TIV (≥ 61 Years)
n=63 Participants
Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited AEs After Receiving One Dose of TIV.
Any AE
|
6 Number of Subjects
|
10 Number of Subjects
|
|
Number of Subjects Reporting Unsolicited AEs After Receiving One Dose of TIV.
At least Possibly related AE
|
5 Number of Subjects
|
6 Number of Subjects
|
PRIMARY outcome
Timeframe: Day 1 to Day 22 post vaccinationPopulation: Analysis was done on the unsolicited safety set population i.e all subjects who have post vaccination unsolicited adverse event data
The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (Day 1 to Day 22), after receiving one vaccination of TIV is reported.
Outcome measures
| Measure |
TIV (18 to ≤ 60 Years)
n=63 Participants
Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
|
TIV (≥ 61 Years)
n=63 Participants
Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited AEs After Receiving One Vaccination of TIV.
Any AE
|
13 Number of Subjects
|
19 Number of Subjects
|
|
Number of Subjects Reporting Unsolicited AEs After Receiving One Vaccination of TIV.
At least Possibly related AEs
|
5 Number of Subjects
|
6 Number of Subjects
|
|
Number of Subjects Reporting Unsolicited AEs After Receiving One Vaccination of TIV.
Any SAE
|
0 Number of Subjects
|
0 Number of Subjects
|
|
Number of Subjects Reporting Unsolicited AEs After Receiving One Vaccination of TIV.
At least Possibly related SAEs
|
0 Number of Subjects
|
0 Number of Subjects
|
|
Number of Subjects Reporting Unsolicited AEs After Receiving One Vaccination of TIV.
Medically attended AEs
|
3 Number of Subjects
|
4 Number of Subjects
|
|
Number of Subjects Reporting Unsolicited AEs After Receiving One Vaccination of TIV.
AEs leading to discontinuation
|
0 Number of Subjects
|
0 Number of Subjects
|
|
Number of Subjects Reporting Unsolicited AEs After Receiving One Vaccination of TIV.
Death
|
0 Number of Subjects
|
0 Number of Subjects
|
Adverse Events
TIV (18 to ≤ 60 Years)
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
TIV (≥ 61 Years)
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Total
Serious events: 0 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TIV (18 to ≤ 60 Years)
n=63 participants at risk
Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
|
TIV (≥ 61 Years)
n=63 participants at risk
Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
|
Total
n=126 participants at risk
|
|---|---|---|---|
|
General disorders
CHILLS
|
3.2%
2/63 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
6.3%
4/63 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
4.8%
6/126 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
|
General disorders
FATIGUE
|
9.5%
6/63 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
6.3%
4/63 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
7.9%
10/126 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
6.3%
4/63 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
11.1%
7/63 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
8.7%
11/126 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
|
General disorders
INJECTION SITE INDURATION
|
6.3%
4/63 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
12.7%
8/63 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
9.5%
12/126 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
|
General disorders
INJECTION SITE PAIN
|
22.2%
14/63 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
14.3%
9/63 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
18.3%
23/126 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
4.8%
3/63 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
7.9%
5/63 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
6.3%
8/126 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
11.1%
7/63 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
9.5%
6/63 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
10.3%
13/126 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
|
Nervous system disorders
HEADACHE
|
22.2%
14/63 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
19.0%
12/63 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
20.6%
26/126 • Throughout the study, up to 22 days.
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place