Trial Outcomes & Findings for A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age (NCT NCT06097273)
NCT ID: NCT06097273
Last Updated: 2025-07-01
Results Overview
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. The Per Protocol Immunogenicity Set (PPIS) included all randomized participants who received study intervention, complied with the timing of immunogenicity blood sample collections to have both Baseline and Day 29 assessments using a window of -7 to +14 days, had no major dosing error, had negative reverse transcription polymerase chain reaction (RT-PCR) test for influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day 1, and had no major protocol deviations or conditions/medications that affected the immune response.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
8061 participants
Primary outcome timeframe
Day 29
Results posted on
2025-07-01
Participant Flow
Participant milestones
| Measure |
Cohort A1: mRNA-1083 and Placebo
Participants of age 65 years and older received mRNA-1083 and placebo administered as 2 intramuscular (IM) injections (1 in each deltoid muscle) on Day 1.
|
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
Participants of age 65 years and older received age recommended influenza vaccine and coronavirus disease 2019 (COVID-19) vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B1: mRNA-1083 and Placebo
Participants of age 50 to \<65 years received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
Participants of age 50 to \<65 years received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2025
|
2012
|
2009
|
2015
|
|
Overall Study
Received Both Injections
|
2011
|
2006
|
1993
|
2005
|
|
Overall Study
COMPLETED
|
1974
|
1977
|
1944
|
1957
|
|
Overall Study
NOT COMPLETED
|
51
|
35
|
65
|
58
|
Reasons for withdrawal
| Measure |
Cohort A1: mRNA-1083 and Placebo
Participants of age 65 years and older received mRNA-1083 and placebo administered as 2 intramuscular (IM) injections (1 in each deltoid muscle) on Day 1.
|
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
Participants of age 65 years and older received age recommended influenza vaccine and coronavirus disease 2019 (COVID-19) vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B1: mRNA-1083 and Placebo
Participants of age 50 to \<65 years received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
Participants of age 50 to \<65 years received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
|---|---|---|---|---|
|
Overall Study
Death
|
2
|
1
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
27
|
18
|
36
|
31
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
3
|
|
Overall Study
Protocol Violation
|
1
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
14
|
11
|
14
|
15
|
|
Overall Study
Other Than Specified
|
7
|
3
|
11
|
6
|
Baseline Characteristics
A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
Baseline characteristics by cohort
| Measure |
Cohort A1: mRNA-1083 and Placebo
n=2025 Participants
Participants of age 65 years and older received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
n=2012 Participants
Participants of age 65 years and older received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B1: mRNA-1083 and Placebo
n=2009 Participants
Participants of age 50 to \<65 years received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
n=2015 Participants
Participants of age 50 to \<65 years received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Total
n=8061 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
70.9 years
STANDARD_DEVIATION 4.96 • n=5 Participants
|
70.7 years
STANDARD_DEVIATION 4.70 • n=7 Participants
|
57.5 years
STANDARD_DEVIATION 4.25 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 4.21 • n=4 Participants
|
64.1 years
STANDARD_DEVIATION 8.06 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1084 Participants
n=5 Participants
|
1100 Participants
n=7 Participants
|
1165 Participants
n=5 Participants
|
1201 Participants
n=4 Participants
|
4550 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
941 Participants
n=5 Participants
|
912 Participants
n=7 Participants
|
844 Participants
n=5 Participants
|
814 Participants
n=4 Participants
|
3511 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
284 Participants
n=5 Participants
|
275 Participants
n=7 Participants
|
393 Participants
n=5 Participants
|
381 Participants
n=4 Participants
|
1333 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1701 Participants
n=5 Participants
|
1695 Participants
n=7 Participants
|
1591 Participants
n=5 Participants
|
1613 Participants
n=4 Participants
|
6600 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
1588 Participants
n=5 Participants
|
1570 Participants
n=7 Participants
|
1382 Participants
n=5 Participants
|
1350 Participants
n=4 Participants
|
5890 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
373 Participants
n=5 Participants
|
370 Participants
n=7 Participants
|
522 Participants
n=5 Participants
|
555 Participants
n=4 Participants
|
1820 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
25 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
153 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Multiple
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown/Not Reported
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: The PPIS. Overall number of participants analyzed = participants evaluable for this outcome measure. Number Analyzed = participants evaluable for specified categories.
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. The Per Protocol Immunogenicity Set (PPIS) included all randomized participants who received study intervention, complied with the timing of immunogenicity blood sample collections to have both Baseline and Day 29 assessments using a window of -7 to +14 days, had no major dosing error, had negative reverse transcription polymerase chain reaction (RT-PCR) test for influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day 1, and had no major protocol deviations or conditions/medications that affected the immune response.
Outcome measures
| Measure |
Cohort A1: mRNA-1083 and Placebo
n=1885 Participants
Participants of age 65 years and older received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
n=1883 Participants
Participants of age 65 years and older received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B1: mRNA-1083 and Placebo
n=1889 Participants
Participants of age 50 to \<65 years received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
n=1883 Participants
Participants of age 50 to \<65 years received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay
Influenza A H1N1 Antibody
|
120.5 titer
Interval 116.0 to 125.2
|
104.3 titer
Interval 100.4 to 108.4
|
137.7 titer
Interval 132.1 to 143.5
|
97.3 titer
Interval 93.4 to 101.5
|
|
Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay
Influenza A H3N2 Antibody
|
114.7 titer
Interval 110.4 to 119.2
|
107.9 titer
Interval 103.9 to 112.1
|
111.5 titer
Interval 107.5 to 115.7
|
80.8 titer
Interval 77.9 to 83.8
|
|
Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay
Influenza B Victoria-lineage Antibody
|
245.3 titer
Interval 237.8 to 252.9
|
219.4 titer
Interval 212.8 to 226.3
|
224.9 titer
Interval 218.0 to 232.0
|
185.0 titer
Interval 179.3 to 190.8
|
|
Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay
Influenza B Yamagata-lineage Antibody
|
93.3 titer
Interval 91.1 to 95.6
|
92.6 titer
Interval 90.4 to 94.9
|
101.7 titer
Interval 99.3 to 104.3
|
88.1 titer
Interval 86.0 to 90.3
|
PRIMARY outcome
Timeframe: Day 29Population: The PPIS. Overall number of participants analyzed = participants evaluable for this outcome measure.
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. The PPIS included all randomized participants who received study intervention, complied with the timing of immunogenicity blood sample collections to have both Baseline and Day 29 assessments using a window of -7 to +14 days, had no major dosing error, had negative RT-PCR test for influenza and SARS-CoV-2 on Day 1, and had no major protocol deviations or conditions/medications that affected the immune response.
Outcome measures
| Measure |
Cohort A1: mRNA-1083 and Placebo
n=1849 Participants
Participants of age 65 years and older received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
n=1859 Participants
Participants of age 65 years and older received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B1: mRNA-1083 and Placebo
n=1854 Participants
Participants of age 50 to \<65 years received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
n=1848 Participants
Participants of age 50 to \<65 years received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
|---|---|---|---|---|
|
GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA)
|
1396.7 titer
Interval 1326.6 to 1470.5
|
851.1 titer
Interval 808.6 to 895.9
|
1551.6 titer
Interval 1476.3 to 1630.7
|
1186.1 titer
Interval 1128.5 to 1246.7
|
PRIMARY outcome
Timeframe: Baseline to Day 29Population: The PPIS. Overall number of participants analyzed = participants evaluable for this outcome measure. Number Analyzed = participants evaluable for specified categories.
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as a Day 29 postinjection level ≥1:40 if Baseline was \<1:10 or a 4-fold or greater rise if Baseline was ≥1:10 in anti-hemagglutinin (HA) antibodies measured by HAI assay. The PPIS included all randomized participants who received study intervention, complied with the timing of immunogenicity blood sample collections to have both Baseline and Day 29 assessments using a window of -7 to +14 days, had no major dosing error, had negative RT-PCR test for influenza and SARS-CoV-2 on Day 1, and had no major protocol deviations or conditions/medications that affected the immune response.
Outcome measures
| Measure |
Cohort A1: mRNA-1083 and Placebo
n=1885 Participants
Participants of age 65 years and older received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
n=1883 Participants
Participants of age 65 years and older received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B1: mRNA-1083 and Placebo
n=1888 Participants
Participants of age 50 to \<65 years received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
n=1882 Participants
Participants of age 50 to \<65 years received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
|---|---|---|---|---|
|
Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza A H1N1 Antibody
|
36.4 percentage of participants
Interval 34.3 to 38.7
|
31.1 percentage of participants
Interval 29.0 to 33.2
|
50.6 percentage of participants
Interval 48.3 to 52.9
|
32.7 percentage of participants
Interval 30.6 to 34.8
|
|
Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza A H3N2 Antibody
|
38.7 percentage of participants
Interval 36.5 to 40.9
|
34.6 percentage of participants
Interval 32.5 to 36.8
|
41.9 percentage of participants
Interval 39.7 to 44.2
|
27.4 percentage of participants
Interval 25.4 to 29.5
|
|
Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza B Victoria-lineage Antibody
|
23.9 percentage of participants
Interval 22.0 to 25.9
|
19.4 percentage of participants
Interval 17.6 to 21.2
|
25.8 percentage of participants
Interval 23.9 to 27.9
|
17.2 percentage of participants
Interval 15.5 to 19.0
|
|
Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza B Yamagata-lineage Antibody
|
8.8 percentage of participants
Interval 7.5 to 10.1
|
10.2 percentage of participants
Interval 8.9 to 11.7
|
13.0 percentage of participants
Interval 11.5 to 14.6
|
10.3 percentage of participants
Interval 9.0 to 11.8
|
PRIMARY outcome
Timeframe: Baseline to Day 29Population: The PPIS. Overall number of participants analyzed = participants evaluable for this outcome measure.
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Seroresponse was defined as a Day 29 postinjection level ≥4-fold rise if Baseline was ≥lower limit of quantification (LLOQ) or ≥4×LLOQ if Baseline value was \<LLOQ in the nAb values measured by PsVNA. LLOQ was 38 arbitrary unit (AU)/milliliter (mL). The PPIS included all randomized participants who received study intervention, complied with the timing of immunogenicity blood sample collections to have both Baseline and Day 29 assessments using a window of -7 to +14 days, had no major dosing error, had negative RT-PCR test for influenza and SARS-CoV-2 on Day 1, and had no major protocol deviations or conditions/medications that affected the immune response.
Outcome measures
| Measure |
Cohort A1: mRNA-1083 and Placebo
n=1841 Participants
Participants of age 65 years and older received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
n=1854 Participants
Participants of age 65 years and older received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B1: mRNA-1083 and Placebo
n=1852 Participants
Participants of age 50 to \<65 years received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
n=1846 Participants
Participants of age 50 to \<65 years received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
|---|---|---|---|---|
|
SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA
|
82.3 percentage of participants
Interval 80.5 to 84.1
|
69.6 percentage of participants
Interval 67.4 to 71.7
|
84.6 percentage of participants
Interval 82.8 to 86.2
|
76.5 percentage of participants
Interval 74.5 to 78.4
|
PRIMARY outcome
Timeframe: Up to 7 days after study injectionPopulation: The Solicited Safety Set included all randomized participants who received any study vaccination and contributed any solicited AR data.
Solicited ARs (local and systemic) were reported by participants an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Outcome measures
| Measure |
Cohort A1: mRNA-1083 and Placebo
n=2011 Participants
Participants of age 65 years and older received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
n=2001 Participants
Participants of age 65 years and older received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B1: mRNA-1083 and Placebo
n=1993 Participants
Participants of age 50 to \<65 years received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
n=2004 Participants
Participants of age 50 to \<65 years received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Any
|
1681 Participants
|
1565 Participants
|
1698 Participants
|
1640 Participants
|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Grade 3 or Grade 4
|
183 Participants
|
84 Participants
|
246 Participants
|
127 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days after study injectionPopulation: The Safety Set included all participants who were randomized and received any study vaccination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Outcome measures
| Measure |
Cohort A1: mRNA-1083 and Placebo
n=2011 Participants
Participants of age 65 years and older received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
n=2006 Participants
Participants of age 65 years and older received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B1: mRNA-1083 and Placebo
n=1993 Participants
Participants of age 50 to \<65 years received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
n=2005 Participants
Participants of age 50 to \<65 years received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events (AEs)
|
239 Participants
|
250 Participants
|
195 Participants
|
191 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 181Population: The Safety Set included all participants who were randomized and received any study vaccination.
An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site. Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (Day 181) are reported in this outcome measure. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Outcome measures
| Measure |
Cohort A1: mRNA-1083 and Placebo
n=2011 Participants
Participants of age 65 years and older received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
n=2006 Participants
Participants of age 65 years and older received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B1: mRNA-1083 and Placebo
n=1993 Participants
Participants of age 50 to \<65 years received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
n=2005 Participants
Participants of age 50 to \<65 years received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
|---|---|---|---|---|
|
Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
SAEs
|
70 Participants
|
52 Participants
|
29 Participants
|
27 Participants
|
|
Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
AESIs
|
18 Participants
|
13 Participants
|
4 Participants
|
9 Participants
|
|
Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
MAAEs
|
426 Participants
|
428 Participants
|
301 Participants
|
304 Participants
|
|
Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
AEs Leading to Discontinuation
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 29Population: The PPIS. Overall number of participants analyzed = participants evaluable for this outcome measure. Number Analyzed = participants evaluable for specified categories.
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI for GMFR was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. PPIS included all randomized participants who received study intervention, complied with the timing of immunogenicity blood sample collections to have both Baseline and Day 29 assessments using a window of -7 to +14 days, had no major dosing error, had negative RT-PCR test for influenza and SARS-CoV-2 on Day 1, and had no major protocol deviations or conditions/medications that affected the immune response.
Outcome measures
| Measure |
Cohort A1: mRNA-1083 and Placebo
n=1885 Participants
Participants of age 65 years and older received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
n=1883 Participants
Participants of age 65 years and older received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B1: mRNA-1083 and Placebo
n=1888 Participants
Participants of age 50 to \<65 years received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
n=1882 Participants
Participants of age 50 to \<65 years received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay
Influenza A H1N1 Antibody
|
2.70 ratio
Interval 2.6 to 2.81
|
2.36 ratio
Interval 2.26 to 2.46
|
3.70 ratio
Interval 3.54 to 3.86
|
2.54 ratio
Interval 2.43 to 2.66
|
|
Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay
Influenza A H3N2 Antibody
|
2.78 ratio
Interval 2.67 to 2.89
|
2.59 ratio
Interval 2.48 to 2.7
|
3.07 ratio
Interval 2.95 to 3.19
|
2.22 ratio
Interval 2.13 to 2.31
|
|
Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay
Influenza B Victoria-lineage
|
2.05 ratio
Interval 1.98 to 2.12
|
1.84 ratio
Interval 1.77 to 1.9
|
2.13 ratio
Interval 2.06 to 2.2
|
1.75 ratio
Interval 1.69 to 1.81
|
|
Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay
Influenza B Yamagata-lineage
|
1.52 ratio
Interval 1.48 to 1.55
|
1.52 ratio
Interval 1.48 to 1.56
|
1.71 ratio
Interval 1.66 to 1.75
|
1.48 ratio
Interval 1.44 to 1.52
|
SECONDARY outcome
Timeframe: Day 1, Day 29Population: The PPIS. Overall number of participants analyzed = participants evaluable for this outcome measure.
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI for GMFR was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. PPIS included all randomized participants who received study intervention, complied with the timing of immunogenicity blood sample collections to have both Baseline and Day 29 assessments using a window of -7 to +14 days, had no major dosing error, had negative RT-PCR test for influenza and SARS-CoV-2 on Day 1, and had no major protocol deviations or conditions/medications that affected the immune response.
Outcome measures
| Measure |
Cohort A1: mRNA-1083 and Placebo
n=1841 Participants
Participants of age 65 years and older received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
n=1854 Participants
Participants of age 65 years and older received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B1: mRNA-1083 and Placebo
n=1852 Participants
Participants of age 50 to \<65 years received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
n=1846 Participants
Participants of age 50 to \<65 years received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
|---|---|---|---|---|
|
GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA
|
16.86 ratio
Interval 15.87 to 17.93
|
10.32 ratio
Interval 9.72 to 10.96
|
17.83 ratio
Interval 16.78 to 18.94
|
13.56 ratio
Interval 12.72 to 14.46
|
SECONDARY outcome
Timeframe: Day 29Population: The PPIS for MN assay.
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. The PPIS for MN assay included a subset of randomized participants who received study intervention to be tested for MN, complied with the timing of immunogenicity blood sampling collections to have both Baseline and Day 29 assessments using a window of -7 to +14 days, had no major dosing error, had negative RT-PCR test for influenza and SARS-CoV-2 on Day 1, and had no major protocol deviations or conditions/medications that affected the immune response.
Outcome measures
| Measure |
Cohort A1: mRNA-1083 and Placebo
n=146 Participants
Participants of age 65 years and older received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
n=146 Participants
Participants of age 65 years and older received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B1: mRNA-1083 and Placebo
n=147 Participants
Participants of age 50 to \<65 years received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
n=147 Participants
Participants of age 50 to \<65 years received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
|---|---|---|---|---|
|
GM Level of Antibodies for Influenza, as Measured by Microneutralization (MN) Assay
Influenza A H1N1 Antibody
|
676.4 titer
Interval 528.8 to 865.3
|
635.9 titer
Interval 489.4 to 826.4
|
946.8 titer
Interval 729.7 to 1228.4
|
428.1 titer
Interval 327.0 to 560.4
|
|
GM Level of Antibodies for Influenza, as Measured by Microneutralization (MN) Assay
Influenza A H3N2 Antibody
|
587.6 titer
Interval 483.9 to 713.6
|
668.8 titer
Interval 538.9 to 830.0
|
645.8 titer
Interval 519.1 to 803.5
|
393.9 titer
Interval 324.7 to 477.9
|
|
GM Level of Antibodies for Influenza, as Measured by Microneutralization (MN) Assay
Influenza B Victoria-lineage Antibody
|
2845.4 titer
Interval 2406.1 to 3364.9
|
3072.5 titer
Interval 2571.0 to 3671.9
|
2901.5 titer
Interval 2457.6 to 3425.6
|
1883.1 titer
Interval 1571.4 to 2256.5
|
|
GM Level of Antibodies for Influenza, as Measured by Microneutralization (MN) Assay
Influenza B Yamagata-lineage Antibody
|
1118.8 titer
Interval 910.4 to 1374.9
|
1434.4 titer
Interval 1200.9 to 1713.3
|
1449.6 titer
Interval 1222.5 to 1719.0
|
1071.3 titer
Interval 883.8 to 1298.4
|
SECONDARY outcome
Timeframe: Day 1, Day 29Population: The PPIS for MN assay.
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI for GMFR was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. The PPIS for MN assay included a subset of randomized participants who received study intervention to be tested for MN, complied with the timing of immunogenicity blood sampling collections to have both Baseline and Day 29 assessments using a window of -7 to +14 days, had no major dosing error, had negative RT-PCR test for influenza and SARS-CoV-2 on Day 1, and had no major protocol deviations or conditions/medications that affected the immune response.
Outcome measures
| Measure |
Cohort A1: mRNA-1083 and Placebo
n=146 Participants
Participants of age 65 years and older received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
n=146 Participants
Participants of age 65 years and older received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B1: mRNA-1083 and Placebo
n=147 Participants
Participants of age 50 to \<65 years received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
n=147 Participants
Participants of age 50 to \<65 years received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
|---|---|---|---|---|
|
GMFR of Antibodies for Influenza, as Measured by MN Assay
Influenza A H1N1 Antibody
|
4.89 ratio
Interval 3.92 to 6.1
|
4.68 ratio
Interval 3.68 to 5.94
|
8.74 ratio
Interval 7.03 to 10.87
|
5.14 ratio
Interval 4.01 to 6.6
|
|
GMFR of Antibodies for Influenza, as Measured by MN Assay
Influenza A H3N2 Antibody
|
2.88 ratio
Interval 2.44 to 3.41
|
2.46 ratio
Interval 2.01 to 3.01
|
3.33 ratio
Interval 2.76 to 4.01
|
1.94 ratio
Interval 1.64 to 2.31
|
|
GMFR of Antibodies for Influenza, as Measured by MN Assay
Influenza B Victoria-lineage
|
3.22 ratio
Interval 2.63 to 3.94
|
3.02 ratio
Interval 2.48 to 3.67
|
3.87 ratio
Interval 3.27 to 4.58
|
3.27 ratio
Interval 2.66 to 4.02
|
|
GMFR of Antibodies for Influenza, as Measured by MN Assay
Influenza B Yamagata-lineage
|
2.98 ratio
Interval 2.56 to 3.46
|
3.38 ratio
Interval 2.75 to 4.15
|
3.66 ratio
Interval 3.02 to 4.44
|
3.42 ratio
Interval 2.79 to 4.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 through Day 181Population: Safety set included all participants who were randomized and received any study vaccination.
A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, irrespective of its perceived relationship to the study drug. The Investigator assessed the causality by determining whether there was a reasonable possibility that the death was related to the study drug, using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable AND/OR the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable.
Outcome measures
| Measure |
Cohort A1: mRNA-1083 and Placebo
n=2025 Participants
Participants of age 65 years and older received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
n=2009 Participants
Participants of age 65 years and older received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B1: mRNA-1083 and Placebo
Participants of age 50 to \<65 years received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
Participants of age 50 to \<65 years received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
|---|---|---|---|---|
|
Number of Deaths Related to Study Drug mRNA-1083 and Placebo
Deaths
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Deaths Related to Study Drug mRNA-1083 and Placebo
Deaths Related to Study Drug mRNA-1083
|
0 Participants
|
0 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 through Day 181Population: Safety set included all participants who were randomized and received any study vaccination.
A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, irrespective of its perceived relationship to the study drug. The Investigator assessed the causality by determining whether there was a reasonable possibility that the death was related to the study drug, using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable AND/OR the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable.
Outcome measures
| Measure |
Cohort A1: mRNA-1083 and Placebo
n=2012 Participants
Participants of age 65 years and older received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
n=2015 Participants
Participants of age 65 years and older received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B1: mRNA-1083 and Placebo
Participants of age 50 to \<65 years received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
Participants of age 50 to \<65 years received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
|---|---|---|---|---|
|
Number of Deaths Related to Control Drug Influenza Vaccine and COVID-19 Vaccine
Deaths
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Deaths Related to Control Drug Influenza Vaccine and COVID-19 Vaccine
Deaths Related to Control Drug
|
0 Participants
|
0 Participants
|
—
|
—
|
Adverse Events
Cohort A1: mRNA-1083 and Placebo
Serious events: 71 serious events
Other events: 0 other events
Deaths: 2 deaths
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
Serious events: 52 serious events
Other events: 0 other events
Deaths: 1 deaths
Cohort B1: mRNA-1083 and Placebo
Serious events: 29 serious events
Other events: 0 other events
Deaths: 2 deaths
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
Serious events: 27 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort A1: mRNA-1083 and Placebo
n=2011 participants at risk
Participants of age 65 years and older received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort A2: Influenza Vaccine and COVID-19 Vaccine
n=2006 participants at risk
Participants of age 65 years and older received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B1: mRNA-1083 and Placebo
n=1993 participants at risk
Participants of age 50 to \<65 years received mRNA-1083 and placebo administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
Cohort B2: Influenza Vaccine and COVID-19 Vaccine
n=2005 participants at risk
Participants of age 50 to \<65 years received age recommended influenza vaccine and COVID-19 vaccine administered as 2 IM injections (1 in each deltoid muscle) on Day 1.
|
|---|---|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Appendicitis
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
COVID-19
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Cellulitis
|
0.10%
2/2011 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Diabetic foot infection
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Extradural abscess
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Gastroenteritis
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Infected bite
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Pneumonia
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.15%
3/2006 • Number of events 3 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.15%
3/2005 • Number of events 3 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Sepsis
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Septic shock
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Streptococcal abscess
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Urinary tract infection
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Urosepsis
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Infections and infestations
Vulval cellulitis
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign abdominal neoplasm
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.15%
3/1993 • Number of events 3 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal adenocarcinoma
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.10%
2/2006 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.10%
2/2011 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.10%
2/2011 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Psychiatric disorders
Bipolar disorder
|
0.05%
1/2011 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Psychiatric disorders
Major depression
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Psychiatric disorders
Mental status changes
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.10%
2/1993 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Psychiatric disorders
Suicidal ideation
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Nervous system disorders
Aphasia
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.15%
3/2011 • Number of events 3 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Nervous system disorders
Headache
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.05%
1/2011 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.10%
2/2011 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Nervous system disorders
Psychogenic seizure
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.10%
2/2006 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Nervous system disorders
Transient global amnesia
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.10%
2/2006 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Cardiac disorders
Angina pectoris
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Cardiac disorders
Atrial fibrillation
|
0.10%
2/2011 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.15%
3/2006 • Number of events 3 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Cardiac disorders
Bradycardia
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.10%
2/2006 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.10%
2/2005 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.10%
2/2006 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Cardiac disorders
Coronary artery disease
|
0.10%
2/2011 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Cardiac disorders
Myocardial infarction
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.10%
2/2006 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Vascular disorders
Hypertension
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.10%
2/2005 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Vascular disorders
Orthostatic hypotension
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.20%
4/2011 • Number of events 4 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.10%
2/2006 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.10%
2/2011 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.10%
2/1993 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.10%
2/2005 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Gastrointestinal disorders
Internal hernia
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.10%
2/2006 • Number of events 3 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.10%
2/2006 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.10%
2/2011 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Renal and urinary disorders
Urinary retention
|
0.10%
2/2011 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Congenital, familial and genetic disorders
Janus kinase 2 mutation
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
General disorders
Asthenia
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
General disorders
Chest pain
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
General disorders
Death
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
General disorders
Non-cardiac chest pain
|
0.15%
3/2011 • Number of events 3 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Investigations
Electrocardiogram abnormal
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.10%
2/2011 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.10%
2/2006 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2005 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Radial head dislocation
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.10%
2/2006 • Number of events 2 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/2006 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/2011 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.05%
1/1993 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.05%
1/2011 • Number of events 1 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2006 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/1993 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
0.00%
0/2005 • Day 1 through Day 181
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who were randomized and received any study vaccination.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place