Trial Outcomes & Findings for A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults (NCT NCT00562484)
NCT ID: NCT00562484
Last Updated: 2017-11-21
Results Overview
Incidence of Laboratory Confirmed Influenza A/B infection was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons. Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / placebo recipient infection rate.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
7500 participants
Primary outcome timeframe
2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Results posted on
2017-11-21
Participant Flow
Participant milestones
| Measure |
CSL's IVV
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
|
Placebo
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
|
|---|---|---|
|
Overall Study
STARTED
|
10033
|
5011
|
|
Overall Study
COMPLETED
|
9827
|
4907
|
|
Overall Study
NOT COMPLETED
|
206
|
104
|
Reasons for withdrawal
| Measure |
CSL's IVV
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
|
Placebo
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
1
|
|
Overall Study
Protocol Violation
|
11
|
2
|
|
Overall Study
Withdrawal by Subject
|
12
|
9
|
|
Overall Study
Moved away from the study area
|
20
|
9
|
|
Overall Study
Lost to Follow-up
|
132
|
71
|
|
Overall Study
Reason not provided or not specified
|
25
|
12
|
Baseline Characteristics
A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults
Baseline characteristics by cohort
| Measure |
CSL's IVV
n=10033 Participants
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
|
Placebo
n=5011 Participants
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
|
Total
n=15044 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10033 Participants
n=5 Participants
|
5011 Participants
n=7 Participants
|
15044 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 14.69 • n=5 Participants
|
35.4 years
STANDARD_DEVIATION 14.69 • n=7 Participants
|
35.5 years
STANDARD_DEVIATION 14.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5523 Participants
n=5 Participants
|
2667 Participants
n=7 Participants
|
8190 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4510 Participants
n=5 Participants
|
2344 Participants
n=7 Participants
|
6854 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
8201 participants
n=5 Participants
|
4090 participants
n=7 Participants
|
12291 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
1832 participants
n=5 Participants
|
921 participants
n=7 Participants
|
2753 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009Population: Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
Incidence of Laboratory Confirmed Influenza A/B infection was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons. Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / placebo recipient infection rate.
Outcome measures
| Measure |
CSL's IVV
n=9889 Participants
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
|
Placebo
n=4960 Participants
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
|
|---|---|---|
|
CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection
|
2.24 Ratio
Interval 1.97 to 2.57
|
3.87 Ratio
Interval 3.37 to 4.44
|
SECONDARY outcome
Timeframe: 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009Population: Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
Incidence of laboratory confirmed influenza A/B infection due to strains matched to vaccine strains was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons. Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / Placebo recipient infection rate.
Outcome measures
| Measure |
CSL's IVV
n=9889 Participants
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
|
Placebo
n=4960 Participants
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
|
|---|---|---|
|
CSL's IVV Vaccine Efficacy Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection Due to Strains Matched to Vaccine Strains
|
0.59 Ratio
Interval 0.45 to 0.76
|
1.47 Ratio
Interval 1.17 to 1.85
|
SECONDARY outcome
Timeframe: 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009Population: Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
The criteria for the protocol defined ILI were as follows: * At least one respiratory symptom: * cough, sore throat or nasal congestion * And at least one systemic symptom: * fever (as defined by oral temperature ≥ 37.8°C (100.0°F), or feverishness (as defined by participant's subjective feeling of fever), chills or body aches. The CDC ILI case definition was the occurrence of fever (100°F \[37.8°C\] or higher) in conjunction with either cough or sore throat.
Outcome measures
| Measure |
CSL's IVV
n=9889 Participants
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
|
Placebo
n=4960 Participants
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
|
|---|---|---|
|
Incidence of Influenza-like Illness (ILI)
Reported ILI (protocol definition)
|
11.9 Percentage of participants
|
13.5 Percentage of participants
|
|
Incidence of Influenza-like Illness (ILI)
Culture-confirmed ILI
|
1.5 Percentage of participants
|
2.4 Percentage of participants
|
|
Incidence of Influenza-like Illness (ILI)
Reported ILI (CDC definition)
|
2.6 Percentage of participants
|
3.6 Percentage of participants
|
|
Incidence of Influenza-like Illness (ILI)
Laboratory-confirmed ILI (CDC definition)
|
0.9 Percentage of participants
|
1.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 21 days after study vaccinationPopulation: Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
Outcome measures
| Measure |
CSL's IVV
n=303 Participants
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
|
Placebo
n=147 Participants
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
|
|---|---|---|
|
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008
H1N1 (A/Solomon Islands/3/2006)
|
99 Percentage of participants
Interval 97.0 to 100.0
|
42 Percentage of participants
Interval 34.0 to 51.0
|
|
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008
H3N2 (A/Brisbane/10/2007)
|
97 Percentage of participants
Interval 94.0 to 98.0
|
35 Percentage of participants
Interval 27.0 to 43.0
|
|
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008
B (B/Brisbane/3/2007)
|
77 Percentage of participants
Interval 72.0 to 82.0
|
13 Percentage of participants
Interval 8.0 to 19.0
|
SECONDARY outcome
Timeframe: 21 days after study vaccinationPopulation: Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
Outcome measures
| Measure |
CSL's IVV
n=291 Participants
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
|
Placebo
n=149 Participants
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
|
|---|---|---|
|
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009
H1N1 (A/Brisbane/59/2007)
|
94 Percentage of participants
Interval 90.0 to 96.0
|
36 Percentage of participants
Interval 28.0 to 44.0
|
|
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009
H3N2 (A/Uruguay/2007)
|
94 Percentage of participants
Interval 90.0 to 96.0
|
43 Percentage of participants
Interval 35.0 to 51.0
|
|
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009
B (B/Florida/4/2006)
|
89 Percentage of participants
Interval 85.0 to 93.0
|
30 Percentage of participants
Interval 23.0 to 38.0
|
SECONDARY outcome
Timeframe: 21 days after study vaccinationPopulation: Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Outcome measures
| Measure |
CSL's IVV
n=303 Participants
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
|
Placebo
n=147 Participants
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
|
|---|---|---|
|
Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008
H1N1 (A/Solomon Islands/3/2006)
|
81 Percentage of participants
Interval 76.0 to 85.0
|
1 Percentage of participants
Interval 0.0 to 4.0
|
|
Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008
H3N2 (A/Brisbane/10/2007)
|
87 Percentage of participants
Interval 82.0 to 90.0
|
1 Percentage of participants
Interval 0.0 to 4.0
|
|
Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008
B (B/Brisbane/3/2007)
|
63 Percentage of participants
Interval 57.0 to 69.0
|
1 Percentage of participants
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: 21 days after study vaccinationPopulation: Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Outcome measures
| Measure |
CSL's IVV
n=291 Participants
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
|
Placebo
n=149 Participants
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
|
|---|---|---|
|
Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009
H1N1 (A/Brisbane/59/2007)
|
78 Percentage of participants
Interval 72.0 to 82.0
|
1 Percentage of participants
Interval 0.0 to 4.0
|
|
Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009
H3N2 (A/Uruguay/2007)
|
81 Percentage of participants
Interval 76.0 to 85.0
|
1 Percentage of participants
Interval 0.0 to 5.0
|
|
Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009
B (B/Florida/4/2006)
|
61 Percentage of participants
Interval 55.0 to 67.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 21 days after study vaccinationPopulation: Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.
Outcome measures
| Measure |
CSL's IVV
n=303 Participants
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
|
Placebo
n=147 Participants
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
|
|---|---|---|
|
Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008
H1N1 (A/Solomon Islands/3/2006)
|
21 Fold increase
Interval 17.0 to 26.0
|
1 Fold increase
Interval 1.0 to 1.0
|
|
Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008
H3N2 (A/Brisbane/10/2007)
|
18 Fold increase
Interval 15.0 to 21.0
|
1 Fold increase
Interval 1.0 to 1.0
|
|
Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008
B (B/Brisbane/3/2007)
|
8 Fold increase
Interval 7.0 to 10.0
|
1 Fold increase
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: 21 days after study vaccinationPopulation: Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.
Outcome measures
| Measure |
CSL's IVV
n=291 Participants
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
|
Placebo
n=149 Participants
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
|
|---|---|---|
|
Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009
H1N1 (A/Brisbane/59/2007)
|
13 Fold increase
Interval 11.0 to 16.0
|
1 Fold increase
Interval 1.0 to 1.0
|
|
Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009
H3N2 (A/Uruguay/2007)
|
15 Fold increase
Interval 13.0 to 18.0
|
1 Fold increase
Interval 1.0 to 1.0
|
|
Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009
B (B/Florida/4/2006)
|
6 Fold increase
Interval 5.0 to 7.0
|
1 Fold increase
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: 5 days after study vaccinationPopulation: Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.
Adverse event grading: Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities. Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities. Grade 3 (severe): Symptoms that prevented normal, everyday activities. Fever Grade 1: ≥ 37.7°C - \< 38.0°C (≥ 99.9 - \< 100.4°F) Grade 2: ≥ 38.0°C - \< 39.0°C (≥ 100.4 - \< 102.2°F) Grade 3: ≥ 39.0°C (\> 102.2°F)
Outcome measures
| Measure |
CSL's IVV
n=10015 Participants
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
|
Placebo
n=5005 Participants
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
|
|---|---|---|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Any local solicited symptom
|
7474 Participants
|
1021 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Any pain
|
4850 Participants
|
539 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Grade 3 pain
|
19 Participants
|
0 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Any tenderness
|
6956 Participants
|
874 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Grade 3 tenderness
|
30 Participants
|
2 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Any redness
|
362 Participants
|
18 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Grade 3 redness
|
3 Participants
|
0 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Any swelling / induration
|
433 Participants
|
20 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Grade 3 swelling / induration
|
6 Participants
|
0 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Any bruising
|
135 Participants
|
29 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Grade 3 bruising
|
1 Participants
|
0 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Any systemic solicited symptom
|
4670 Participants
|
1955 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Any fever
|
258 Participants
|
93 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Grade 3 fever
|
8 Participants
|
2 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Any headache
|
2553 Participants
|
1176 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Grade 3 headache
|
43 Participants
|
19 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Any malaise
|
2916 Participants
|
1277 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Grade 3 malaise
|
67 Participants
|
24 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Any myalgia
|
2150 Participants
|
609 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Grade 3 myalgia
|
33 Participants
|
5 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Any chills
|
509 Participants
|
187 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Grade 3 chills
|
17 Participants
|
3 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Any nausea
|
678 Participants
|
287 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Grade 3 nausea
|
22 Participants
|
16 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Any vomiting
|
83 Participants
|
38 Participants
|
|
Frequency and Intensity of Local and Systemic Solicited Symptoms
Grade 3 vomiting
|
10 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 21 days after study vaccinationPopulation: Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.
UAE grading: Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities. Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities. Grade 3 (severe): Symptoms that prevented normal, everyday activities.
Outcome measures
| Measure |
CSL's IVV
n=9889 Participants
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
|
Placebo
n=4960 Participants
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
|
|---|---|---|
|
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Number of participants with at least one UAE
|
3519 Participants
|
1698 Participants
|
|
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Number of participants reported Grade 1 UAE
|
1604 Participants
|
750 Participants
|
|
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Number of participants reported Grade 2 UAE
|
1536 Participants
|
784 Participants
|
|
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Number of participants reported Grade 3 UAE
|
378 Participants
|
162 Participants
|
SECONDARY outcome
Timeframe: 180 days after study vaccinationPopulation: Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.
An SAE was any untoward medical occurrence that at any dose: * Resulted in death; * Was life-threatening; * Required an unexpected in-participant hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability / incapacity; * Was a congenital anomaly / birth defect; and / or * Was medically significant (defined as an event that did not necessarily meet any of the SAE criteria, but was judged by the treating physician to potentially jeopardize the participant or require medical intervention to prevent one of the out
Outcome measures
| Measure |
CSL's IVV
n=9889 Participants
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
|
Placebo
n=4960 Participants
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
|
|---|---|---|
|
Serious Adverse Events (SAEs)
Number of participants with at least one SAE
|
100 Participants
|
44 Participants
|
|
Serious Adverse Events (SAEs)
Number rof participants with related SAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 180 days after study vaccinationPopulation: Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.
An NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).
Outcome measures
| Measure |
CSL's IVV
n=9889 Participants
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
|
Placebo
n=4960 Participants
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
|
|---|---|---|
|
New Onsets of Chronic Illness (NOCI)
Number of participants with at least one NOCI
|
80 Participants
|
46 Participants
|
|
New Onsets of Chronic Illness (NOCI)
Number of participants with related NOCI
|
3 Participants
|
0 Participants
|
Adverse Events
CSL's IVV
Serious events: 100 serious events
Other events: 3028 other events
Deaths: 0 deaths
Placebo
Serious events: 44 serious events
Other events: 1549 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CSL's IVV
n=10015 participants at risk
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
|
Placebo
n=5005 participants at risk
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
|
|---|---|---|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Reproductive system and breast disorders
Endometriosis
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Congenital, familial and genetic disorders
Bicuspid aortic valve
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Congenital, familial and genetic disorders
Heart disease congenital
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Appendicitis
|
0.08%
8/10015 • Number of events 8 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.04%
2/5005 • Number of events 2 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Cellulitis
|
0.04%
4/10015 • Number of events 4 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.04%
2/5005 • Number of events 2 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Pneumonia
|
0.02%
2/10015 • Number of events 2 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.04%
2/5005 • Number of events 2 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Vestibular neuronitis
|
0.02%
2/10015 • Number of events 2 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Viral infection
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Bartholin's abscess
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Gastroenteritis
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Gastroenteritis viral
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Herpes simplex hepatitis
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Liver abscess
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Measles
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Peritonsillar abscess
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Pyomyositis
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Tonsillitis
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Urosepsis
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.04%
4/10015 • Number of events 4 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B precursor type acute leukaemia
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage II
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma metastatic
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Uterine leiomyoma
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Immune system disorders
Amyloidosis
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Metabolism and nutrition disorders
Dehydration
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Psychiatric disorders
Depression
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Psychiatric disorders
Major depression
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Nervous system disorders
cervical myelopathy
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Nervous system disorders
Headache
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Nervous system disorders
Paraplegia
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Nervous system disorders
Presyncope
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Nervous system disorders
Syncope
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Nervous system disorders
Transient ischaemic attack
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Cardiac disorders
Acute myocardial infarction
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Cardiac disorders
Myocardial infarction
|
0.02%
2/10015 • Number of events 2 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Cardiac disorders
Angina unstable
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Cardiac disorders
Cardiac arrest
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Cardiac disorders
Coronary artery disease
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Vascular disorders
Deep vein thrombosis
|
0.02%
2/10015 • Number of events 2 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal inflammation
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Gastrointestinal disorders
Pancreatitis
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.04%
2/5005 • Number of events 2 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Gastrointestinal disorders
Crohn's disease
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Gastrointestinal disorders
Ileitis
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Gastrointestinal disorders
Intussusception
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Gastrointestinal disorders
Umbilical hernia obstructive
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Gastrointestinal disorders
Uvulitis
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.02%
2/10015 • Number of events 2 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Renal and urinary disorders
Renal cyst ruptured
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Renal and urinary disorders
Ruptured ectopic pregnancy
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.02%
2/10015 • Number of events 2 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Congenital, familial and genetic disorders
Trisomy 21
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.04%
2/5005 • Number of events 2 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.02%
2/10015 • Number of events 2 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Anaesthetic complication pulmonary
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Head injury
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Pubic rami fracture
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Borderline ovarian tumour
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/10015 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.02%
1/5005 • Number of events 2 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Injury, poisoning and procedural complications
Heart injury
|
0.01%
1/10015 • Number of events 1 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
0.00%
0/5005 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
Other adverse events
| Measure |
CSL's IVV
n=10015 participants at risk
Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
|
Placebo
n=5005 participants at risk
Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
3.9%
387/10015 • Number of events 402 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
4.0%
201/5005 • Number of events 205 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Nervous system disorders
Headache
|
11.3%
1128/10015 • Number of events 1567 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
11.1%
558/5005 • Number of events 712 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
501/10015 • Number of events 529 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
5.2%
258/5005 • Number of events 276 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.5%
248/10015 • Number of events 273 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
3.0%
150/5005 • Number of events 160 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
220/10015 • Number of events 228 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
2.1%
104/5005 • Number of events 112 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
1.5%
155/10015 • Number of events 163 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
1.6%
80/5005 • Number of events 82 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
135/10015 • Number of events 155 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
1.4%
70/5005 • Number of events 78 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
1.4%
144/10015 • Number of events 148 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
1.5%
73/5005 • Number of events 77 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
110/10015 • Number of events 113 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
1.1%
55/5005 • Number of events 56 • 21 days after study vaccination for unsolicited adverse events and 180 days after study vaccination for serious adverse events.
Other adverse events presented were unsolicited adverse events up to 21 days after study vaccination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60