Trial Outcomes & Findings for Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults (NCT NCT00744263)
NCT ID: NCT00744263
Last Updated: 2014-10-06
Results Overview
CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature greater than (\>) 38.0 degrees Celsius (C) or less than (\<) 36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (\>10\*10\^9 white blood cells/liter or \>15 percent (%) bands), C-reactive protein level \>3 times upper limit of normal, hypoxemia with partial oxygen pressure \<60 millimeter of mercury (mmHg). Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: VT Streptococcus pneumonia culture from blood, pleural fluid or other sterile site and/or positive VT serotype-specific urinary antigen detection (SSUAD).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
84496 participants
Primary outcome timeframe
Baseline up to occurrence of first episode of VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)
Results posted on
2014-10-06
Participant Flow
Of 84496 participants who were randomized in this study, 2011 participants were included in the immunogenicity subset. Participants in the immunogenicity subset were analyzed for local reactions and systemic events as per planned analysis.
Participant milestones
| Measure |
13vPnC
Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
|
Placebo
Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
42240
|
42256
|
|
Overall Study
COMPLETED
|
37004
|
36936
|
|
Overall Study
NOT COMPLETED
|
5236
|
5320
|
Reasons for withdrawal
| Measure |
13vPnC
Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
|
Placebo
Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
|
|---|---|---|
|
Overall Study
Death
|
3006
|
3005
|
|
Overall Study
Lost to Follow-up
|
2038
|
2135
|
|
Overall Study
Withdrawal by Subject
|
166
|
150
|
|
Overall Study
Physician Decision
|
20
|
23
|
|
Overall Study
Protocol Violation
|
3
|
5
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Other
|
2
|
2
|
Baseline Characteristics
Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults
Baseline characteristics by cohort
| Measure |
13vPnC
n=42237 Participants
Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
|
Placebo
n=42255 Participants
Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
|
Total
n=84492 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.8 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
72.8 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
72.8 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18790 Participants
n=5 Participants
|
18454 Participants
n=7 Participants
|
37244 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23447 Participants
n=5 Participants
|
23801 Participants
n=7 Participants
|
47248 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to occurrence of first episode of VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)Population: Per-protocol(PP) population: eligible participants who received study vaccine, 65 years or older, identified with CAP(pre-defined criteria) or had invasive pneumococcal disease(IPD); symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.
CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature greater than (\>) 38.0 degrees Celsius (C) or less than (\<) 36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (\>10\*10\^9 white blood cells/liter or \>15 percent (%) bands), C-reactive protein level \>3 times upper limit of normal, hypoxemia with partial oxygen pressure \<60 millimeter of mercury (mmHg). Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: VT Streptococcus pneumonia culture from blood, pleural fluid or other sterile site and/or positive VT serotype-specific urinary antigen detection (SSUAD).
Outcome measures
| Measure |
13vPnC
n=42240 Participants
Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
|
Placebo
n=42256 Participants
Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
|
|---|---|---|
|
Number of Participants With First Episode of Confirmed Vaccine-type Community-acquired Pneumonia (VT-CAP)
|
49 participants
|
90 participants
|
SECONDARY outcome
Timeframe: Baseline up to occurrence of first episode of NB/NI VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)Population: PP population: eligible participants who received study vaccine, 65 years or older, identified with CAP (pre-defined criteria) or had IPD; symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.
CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature \>38.0 degrees C or \<36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (\>10\*10\^9 white blood cells/liter or \>15% bands), C-reactive protein level \>3 times upper limit of normal, hypoxemia with partial oxygen pressure \<60 mmHg. Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: Confirmed VT pneumococcal CAP (by SSUAD) where a blood culture result was available and was negative and for which any other sterile culture results were negative for Streptococcus pneumoniae.
Outcome measures
| Measure |
13vPnC
n=42240 Participants
Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
|
Placebo
n=42256 Participants
Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
|
|---|---|---|
|
Number of Participants With First Episode of Nonbacteremic/Noninvasive (NB/NI) Vaccine-type Community-acquired Pneumonia (VT-CAP)
|
33 participants
|
60 participants
|
SECONDARY outcome
Timeframe: Baseline up to occurrence of first episode of VT-IPD, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)Population: PP population: eligible participants who received study vaccine, 65 years or older, identified with CAP (pre-defined criteria) or had IPD; symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.
VT-IPD was defined as the presence of Streptococcus pneumoniae in a sterile site (blood, cerebrospinal fluid, pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, or joint fluid).
Outcome measures
| Measure |
13vPnC
n=42240 Participants
Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
|
Placebo
n=42256 Participants
Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
|
|---|---|---|
|
Number of Participants With First Episodes of Vaccine-type Invasive Pneumococcal Disease (VT-IPD) Cases
|
7 participants
|
28 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after vaccinationPopulation: Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction.
Local reactions were reported using electronic diary (e-diary). Redness and swelling scaled as Any (redness or swelling present); Absent (no or minimal); Mild (2.5 centimeter \[cm\] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (\>10.0 cm). Pain scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Limitation of arm movement scaled as Any (limitation present); Absent (no limitation of arm movement); Mild (some limitation of arm movement); Moderate (unable to move arm above head, but able to move arm above shoulder); Severe (unable to move arm above shoulder). Percentage of participants with local reactions were reported. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=917 Participants
Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
|
Placebo
n=867 Participants
Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
|
|---|---|---|
|
Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Pain: Moderate (n = 886, 860)
|
7.7 percentage of participants
Interval 6.0 to 9.6
|
0.6 percentage of participants
Interval 0.2 to 1.4
|
|
Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Pain: Severe (n = 881, 860)
|
0.3 percentage of participants
Interval 0.1 to 1.0
|
0.1 percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Redness: Any (n = 886, 859)
|
4.9 percentage of participants
Interval 3.5 to 6.5
|
1.2 percentage of participants
Interval 0.6 to 2.1
|
|
Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Redness: Mild (n = 886, 859)
|
3.7 percentage of participants
Interval 2.6 to 5.2
|
0.8 percentage of participants
Interval 0.3 to 1.7
|
|
Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Redness: Moderate (n = 881, 859)
|
1.7 percentage of participants
Interval 1.0 to 2.8
|
0.3 percentage of participants
Interval 0.1 to 1.0
|
|
Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Redness: Severe (n = 881, 859)
|
0.5 percentage of participants
Interval 0.1 to 1.2
|
0.1 percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Swelling: Any (n = 888, 859)
|
6.8 percentage of participants
Interval 5.2 to 8.6
|
1.2 percentage of participants
Interval 0.6 to 2.1
|
|
Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Swelling: Mild (n = 888, 859)
|
5.5 percentage of participants
Interval 4.1 to 7.2
|
0.7 percentage of participants
Interval 0.3 to 1.5
|
|
Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Swelling: Moderate (n = 884, 859)
|
2.6 percentage of participants
Interval 1.7 to 3.9
|
0.6 percentage of participants
Interval 0.2 to 1.4
|
|
Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Swelling: Severe (n = 881, 859)
|
0.1 percentage of participants
Interval 0.0 to 0.6
|
0.1 percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Pain: Any (n = 914, 863)
|
36.1 percentage of participants
Interval 33.0 to 39.3
|
6.1 percentage of participants
Interval 4.6 to 8.0
|
|
Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Pain: Mild (n = 913, 861)
|
32.9 percentage of participants
Interval 29.8 to 36.0
|
5.6 percentage of participants
Interval 4.1 to 7.3
|
|
Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Limitation of arm movement: Any (n = 891, 865)
|
14.1 percentage of participants
Interval 11.9 to 16.6
|
3.2 percentage of participants
Interval 2.2 to 4.6
|
|
Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Limitation of arm movement: Mild (n = 888, 863)
|
12.4 percentage of participants
Interval 10.3 to 14.7
|
2.5 percentage of participants
Interval 1.6 to 3.8
|
|
Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Limitation of arm movement: Moderate (n =883, 860)
|
1.7 percentage of participants
Interval 1.0 to 2.8
|
0.5 percentage of participants
Interval 0.1 to 1.2
|
|
Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
Limitation of arm movement: Severe (n = 882, 861)
|
1.2 percentage of participants
Interval 0.6 to 2.2
|
0.7 percentage of participants
Interval 0.3 to 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after vaccinationPopulation: Immunogenicity subset. Participants may be represented in more than 1 category. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event.
Systemic events (fever, fatigue, headache, chills, rash, vomiting, decreased appetite, diarrhea, new generalized muscle/joint pain \[new muscle/joint pain\], aggravated generalized muscle/joint pain \[aggravated muscle/joint pain\], use of medication to treat pain/fever) reported using an e-diary. Fever scaled as Absent(\<38 degrees C); Mild(greater than or equal to \[\>=\]38 to \<38.5 degrees C); Moderate(\>=38.5 to \<39 degrees C); Severe(\>=39 to less than or equal to \[\<=\]40 degrees C); Potentially life threatening (\>40 degrees C). Fatigue, headache, new/aggravated muscle/joint pain scaled as Mild(no interference); Moderate(some interference); Severe(prevented routine activity). Vomiting scaled as Mild(1-2 times in 24 hours \[hrs\]); Moderate(\>2 times in 24 hrs); Severe(required intravenous hydration). Diarrhea scaled as Mild(2-3 loose stools in 24 hrs); Moderate(4-5 loose stools in 24 hrs); Severe(\>=6 loose stools in 24 hrs). Percentage of participants with systemic events were reported.
Outcome measures
| Measure |
13vPnC
n=918 Participants
Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
|
Placebo
n=907 Participants
Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
|
|---|---|---|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Fever: >=38 to <38.5 degrees C (n = 883, 859)
|
1.1 percentage of participants
Interval 0.5 to 2.1
|
0.6 percentage of participants
Interval 0.2 to 1.4
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Fever: >=38.5 to <39 degrees C (n = 881, 859)
|
0.6 percentage of participants
Interval 0.2 to 1.3
|
0.2 percentage of participants
Interval 0.0 to 0.8
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Fever: >=39 to =<40 degrees C (n = 882, 859)
|
0.7 percentage of participants
Interval 0.3 to 1.5
|
0.2 percentage of participants
Interval 0.0 to 0.8
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Fever: >40 degrees C (n = 882, 860)
|
0.8 percentage of participants
Interval 0.3 to 1.6
|
0.3 percentage of participants
Interval 0.1 to 1.0
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Fatigue: Mild (n = 892, 871)
|
13.8 percentage of participants
Interval 11.6 to 16.2
|
11.7 percentage of participants
Interval 9.7 to 14.0
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Fatigue: Moderate (n = 886, 866)
|
7.8 percentage of participants
Interval 6.1 to 9.8
|
6.2 percentage of participants
Interval 4.7 to 8.1
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Fatigue: Severe (n = 883, 863)
|
1.4 percentage of participants
Interval 0.7 to 2.4
|
0.9 percentage of participants
Interval 0.4 to 1.8
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Headache: Mild (n = 891, 870)
|
13.0 percentage of participants
Interval 10.9 to 15.4
|
13.1 percentage of participants
Interval 10.9 to 15.5
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Headache: Moderate (n = 883, 868)
|
5.2 percentage of participants
Interval 3.8 to 6.9
|
3.8 percentage of participants
Interval 2.6 to 5.3
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Headache: Severe (n = 881, 861)
|
0.6 percentage of participants
Interval 0.2 to 1.3
|
0.6 percentage of participants
Interval 0.2 to 1.3
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Chills (n = 891, 866)
|
9.4 percentage of participants
Interval 7.6 to 11.5
|
8.4 percentage of participants
Interval 6.7 to 10.5
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Rash (n = 882, 860)
|
3.3 percentage of participants
Interval 2.2 to 4.7
|
0.8 percentage of participants
Interval 0.3 to 1.7
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Vomiting: Mild (n = 881, 860)
|
0.0 percentage of participants
Interval 0.0 to 0.4
|
0.7 percentage of participants
Interval 0.3 to 1.5
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Vomiting: Moderate (n =881, 860)
|
0.1 percentage of participants
Interval 0.0 to 0.6
|
0.1 percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Vomiting: Severe (n = 881, 860)
|
0.2 percentage of participants
Interval 0.0 to 0.8
|
0.1 percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Decreased appetite (n = 886, 865)
|
5.3 percentage of participants
Interval 3.9 to 7.0
|
3.7 percentage of participants
Interval 2.5 to 5.2
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Diarrhea: Mild (n = 887, 868)
|
5.1 percentage of participants
Interval 3.7 to 6.7
|
7.7 percentage of participants
Interval 6.0 to 9.7
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Diarrhea: Moderate (n = 882, 863)
|
1.2 percentage of participants
Interval 0.6 to 2.2
|
1.0 percentage of participants
Interval 0.5 to 2.0
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Diarrhea: Severe (n = 881, 862)
|
0.7 percentage of participants
Interval 0.3 to 1.5
|
0.5 percentage of participants
Interval 0.1 to 1.2
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
New muscle pain: Mild (n = 894, 865)
|
14.5 percentage of participants
Interval 12.3 to 17.0
|
6.7 percentage of participants
Interval 5.1 to 8.6
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
New muscle pain: Moderate (n = 886, 863)
|
5.9 percentage of participants
Interval 4.4 to 7.6
|
2.8 percentage of participants
Interval 1.8 to 4.1
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
New muscle pain: Severe (n = 882, 860)
|
0.7 percentage of participants
Interval 0.3 to 1.5
|
0.5 percentage of participants
Interval 0.1 to 1.2
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Aggravated muscle pain: Mild (n = 886, 862)
|
4.6 percentage of participants
Interval 3.3 to 6.2
|
1.9 percentage of participants
Interval 1.1 to 3.0
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Aggravated muscle pain: Moderate (n = 885, 863)
|
5.1 percentage of participants
Interval 3.7 to 6.7
|
2.8 percentage of participants
Interval 1.8 to 4.1
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Aggravated muscle pain: Severe (n = 882, 860)
|
0.7 percentage of participants
Interval 0.3 to 1.5
|
0.1 percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
New joint pain: Mild (n = 884, 862)
|
5.0 percentage of participants
Interval 3.6 to 6.6
|
3.9 percentage of participants
Interval 2.7 to 5.5
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
New joint pain: Moderate (n = 883, 864)
|
2.9 percentage of participants
Interval 1.9 to 4.3
|
2.2 percentage of participants
Interval 1.3 to 3.4
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
New joint pain: Severe (n = 882, 860)
|
0.3 percentage of participants
Interval 0.1 to 1.0
|
0.3 percentage of participants
Interval 0.1 to 1.0
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Aggravated joint pain: Mild (n = 883, 861)
|
2.3 percentage of participants
Interval 1.4 to 3.5
|
1.7 percentage of participants
Interval 1.0 to 2.9
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Aggravated joint pain: Moderate (n = 884, 862)
|
3.2 percentage of participants
Interval 2.1 to 4.5
|
2.6 percentage of participants
Interval 1.6 to 3.8
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Aggravated joint pain: Severe (n = 882, 860)
|
0.3 percentage of participants
Interval 0.1 to 1.0
|
0.3 percentage of participants
Interval 0.1 to 1.0
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Use of medication to treat pain (n = 887, 872)
|
8.0 percentage of participants
Interval 6.3 to 10.0
|
6.2 percentage of participants
Interval 4.7 to 8.0
|
|
Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
Use of medication to treat fever (n = 883, 863)
|
3.2 percentage of participants
Interval 2.1 to 4.6
|
1.5 percentage of participants
Interval 0.8 to 2.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From signing of informed consent form up to case acquisition period defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)Population: Safety population included all participants who received study vaccine and who had any safety data.
Deaths collected throughout the case acquisition period were presented.
Outcome measures
| Measure |
13vPnC
n=42237 Participants
Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
|
Placebo
n=42255 Participants
Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
|
|---|---|---|
|
Percentage of Participants Who Died
|
7.1 percentage of participants
|
7.1 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 1 month after vaccination up to 6 months after vaccinationPopulation: Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
Percentage of participants with newly diagnosed chronic medical conditions (including autoimmune or neuroinflammatory disease) in the immunogenicity subset were reported as per planned analysis.
Outcome measures
| Measure |
13vPnC
n=1006 Participants
Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
|
Placebo
n=1005 Participants
Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
|
|---|---|---|
|
Percentage of Participants With Newly Diagnosed Chronic Medical Condition
|
1.7 percentage of participants
|
1.2 percentage of participants
|
Adverse Events
13vPnC Safety Set
Serious events: 327 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Safety Set
Serious events: 314 serious events
Other events: 0 other events
Deaths: 0 deaths
13vPnC Immunogenicity Subset
Serious events: 55 serious events
Other events: 363 other events
Deaths: 0 deaths
Placebo Immunogenicity Subset
Serious events: 48 serious events
Other events: 315 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC Safety Set
n=42237 participants at risk
All Participants who received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1, were assessed for serious adverse events (SAEs) from vaccination up to 1 month after vaccination. Safety set included all participants who received study vaccine and who had any safety data.
|
Placebo Safety Set
n=42255 participants at risk
All participants who received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from vaccination up to 1 month after vaccination. Safety set included all participants who received study vaccine and who had any safety data.
|
13vPnC Immunogenicity Subset
n=1006 participants at risk
Participants included in immunogenicity subset who received a single 0.5 mL dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from 1 month after vaccination up to 6 months after vaccination and for Other adverse events (AEs) from vaccination up to 1 month after vaccination. Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
|
Placebo Immunogenicity Subset
n=1005 participants at risk
Participants included in immunogenicity subset who received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from 1 month after vaccination up to 6 months after vaccination and for Other AEs from vaccination up to 1 month after vaccination. Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Angina pectoris
|
0.04%
19/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.04%
19/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.30%
3/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
0.03%
13/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.02%
9/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.30%
3/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Myocardial infarction
|
0.03%
12/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
6/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Cardiac failure
|
0.02%
7/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.02%
10/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.40%
4/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Atrial flutter
|
0.01%
5/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Coronary artery disease
|
0.01%
3/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
4/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
3/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Cardiac asthma
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
3/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Angina unstable
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Pericarditis
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Coronary artery dissection
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Eye disorders
Retinal detachment
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
4/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Constipation
|
0.01%
4/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Non-cardiac chest pain
|
0.03%
12/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Chest pain
|
0.01%
5/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Device dislocation
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Accidental death
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Death
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Device occlusion
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Hernia obstructive
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Malaise
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Medical device complication
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Pyrexia
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Sudden cardiac death
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Implant site fibrosis
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Immune system disorders
Corneal graft rejection
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Pneumonia
|
0.03%
14/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
6/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.40%
4/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Appendicitis
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
4/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Device related infection
|
0.01%
3/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
3/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Urosepsis
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
3/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
3/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Diverticulitis
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Wound infection
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Cholangitis suppurative
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Cystitis
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Erysipelas
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Herpes zoster
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Meningitis
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Peritonitis
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Viral infection
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.01%
5/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
4/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.01%
3/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
3/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.01%
3/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
4/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
3/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
3/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.01%
3/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
3/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Foreign body aspiration
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Kidney contusion
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Mental status changes postoperative
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Post laminectomy syndrome
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Investigations
Weight decreased
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Finger deformity
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
1.00%
10/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.05%
22/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.04%
16/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.02%
10/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.02%
7/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.02%
7/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
6/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
3/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
3/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder adenocarcinoma stage unspecified
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic adenoma
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of renal pelvis
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma recurrent
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Peripheral nerve lesion
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma recurrent
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct adenocarcinoma
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer recurrent
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.02%
9/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.02%
8/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.30%
3/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Cerebral infarction
|
0.01%
4/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.02%
9/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.02%
8/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
5/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Syncope
|
0.01%
3/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
3/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Presyncope
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
3/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Dizziness
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Acute disseminated encephalomyelitis
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Convulsion
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Radicular pain
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Radiculitis lumbosacral
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.03%
13/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.02%
8/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.01%
3/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.01%
3/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis allergic
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Vascular disorders
Circulatory collapse
|
0.01%
3/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
2/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.01%
3/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Vascular disorders
Hypertension
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Vascular disorders
Hypotension
|
0.00%
2/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Vascular disorders
Haematoma
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
1/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Vascular disorders
Temporal arteritis
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
1/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/42237 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/42255 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
Other adverse events
| Measure |
13vPnC Safety Set
n=42237 participants at risk
All Participants who received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1, were assessed for serious adverse events (SAEs) from vaccination up to 1 month after vaccination. Safety set included all participants who received study vaccine and who had any safety data.
|
Placebo Safety Set
n=42255 participants at risk
All participants who received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from vaccination up to 1 month after vaccination. Safety set included all participants who received study vaccine and who had any safety data.
|
13vPnC Immunogenicity Subset
n=1006 participants at risk
Participants included in immunogenicity subset who received a single 0.5 mL dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from 1 month after vaccination up to 6 months after vaccination and for Other adverse events (AEs) from vaccination up to 1 month after vaccination. Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
|
Placebo Immunogenicity Subset
n=1005 participants at risk
Participants included in immunogenicity subset who received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from 1 month after vaccination up to 6 months after vaccination and for Other AEs from vaccination up to 1 month after vaccination. Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Cardiac failure
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Mitral valve incompetence
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Palpitations
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Cardiac disorders
Tachycardia
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Ear and labyrinth disorders
Vertigo
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Eye disorders
Conjunctivitis
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.50%
5/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Eye disorders
Cataract
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Eye disorders
Conjunctivitis allergic
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Eye disorders
Ocular hyperaemia
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Eye disorders
Vitreous floaters
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.30%
3/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.50%
5/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.30%
3/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Pyrexia
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Change of bowel habit
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Eructation
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Gastritis
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Haemorrhoids
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Injection site erythema
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
3.0%
30/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Injection site pain
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
1.8%
18/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Injection site pruritus
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.99%
10/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Injection site swelling
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.99%
10/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Malaise
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.40%
4/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.30%
3/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Fatigue
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.40%
4/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Injection site haematoma
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Injection site exfoliation
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Chills
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
9.4%
84/891 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
8.4%
73/866 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Cyst
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Device breakage
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Ill-defined disorder
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Injection site rash
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Injection site reaction
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Oedema peripheral
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Vaccination site erythema
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Vessel puncture site haematoma
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Hepatobiliary disorders
Cholelithiasis
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Nasopharyngitis
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
1.2%
12/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
2.0%
20/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.80%
8/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
1.7%
17/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Cystitis
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.50%
5/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.80%
8/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Gastroenteritis
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.40%
4/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.90%
9/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Bronchitis
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.50%
5/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.40%
4/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Influenza
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.40%
4/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.50%
5/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Herpes zoster
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Pneumonia
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.30%
3/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Sinusitis
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Fungal infection
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Urinary tract infection
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Wound infection
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Abscess oral
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Enteritis infectious
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Folliculitis
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Fungal skin infection
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Lower respiratory tract infection
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Oral herpes
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Otitis externa
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Otitis media
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Infections and infestations
Tinea barbae
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Limb injury
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Contusion
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Concussion
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Face injury
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Periorbital contusion
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Investigations
International normalised ratio decreased
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.30%
3/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Metabolism and nutrition disorders
Gout
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.50%
5/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.30%
3/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.30%
3/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.30%
3/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.40%
4/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.30%
3/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Inclusion body myositis
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Headache
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.70%
7/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Dizziness
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.30%
3/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.30%
3/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Ageusia
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Aphonia
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Cerebrovascular accident
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Neuropathy peripheral
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Paraesthesia
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Sciatica
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Syncope
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Nervous system disorders
Transient ischaemic attack
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Renal and urinary disorders
Haematuria
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Renal and urinary disorders
Nephrolithiasis
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Renal and urinary disorders
Urinary retention
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.50%
5/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.30%
3/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.20%
2/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Vascular disorders
Hypertension
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Vascular disorders
Peripheral coldness
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/1006 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.10%
1/1005 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Redness: Any
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
4.9%
43/886 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
1.2%
10/859 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Redness: Mild
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
3.7%
33/886 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.81%
7/859 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Redness: Moderate
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
1.7%
15/881 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.35%
3/859 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Redness: Severe
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.45%
4/881 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.12%
1/859 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Swelling: Any
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
6.8%
60/888 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
1.2%
10/859 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Swelling: Mild
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
5.5%
49/888 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.70%
6/859 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Swelling: Moderate
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
2.6%
23/884 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.58%
5/859 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Swelling: Severe
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.11%
1/881 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.12%
1/859 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Pain: Any
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
36.1%
330/914 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
6.1%
53/863 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Pain: Mild
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
32.9%
300/913 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
5.6%
48/861 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Pain: Moderate
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
7.7%
68/886 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.58%
5/860 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Pain: Severe
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.34%
3/881 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.12%
1/860 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Limitation of arm movement: Any
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
14.1%
126/891 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
3.2%
28/865 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Limitation of arm movement: Mild
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
12.4%
110/888 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
2.5%
22/863 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Limitation of arm movement: Moderate
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
1.7%
15/883 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.47%
4/860 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Limitation of arm movement: Severe
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
1.2%
11/882 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.70%
6/861 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Fever: >=38 to <38.5 degrees C
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
1.1%
10/883 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.58%
5/859 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Fever: >=38.5 to <39 degrees C
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.57%
5/881 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.23%
2/859 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Fever: >=39 to =<40 degrees C
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.68%
6/882 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.23%
2/859 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Fever: >40 degrees C
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.79%
7/882 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.35%
3/860 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Fatigue: Mild
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
13.8%
123/892 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
11.7%
102/871 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Fatigue: Moderate
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
7.8%
69/886 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
6.2%
54/866 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Fatigue: Severe
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
1.4%
12/883 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.93%
8/863 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Headache: Mild
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
13.0%
116/891 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
13.1%
114/870 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Headache: Moderate
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
5.2%
46/883 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
3.8%
33/868 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Headache: Severe
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.57%
5/881 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.58%
5/861 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Rash
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
3.3%
29/882 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.81%
7/860 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Vomiting: Mild
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.00%
0/881 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.70%
6/860 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Vomiting: Moderate
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.11%
1/881 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.12%
1/860 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Vomiting: Severe
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.23%
2/881 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.12%
1/860 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Decreased appetite
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
5.3%
47/886 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
3.7%
32/865 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Diarrhea: Mild
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
5.1%
45/887 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
7.7%
67/868 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Diarrhea: Moderate
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
1.2%
11/882 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
1.0%
9/863 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Diarrhea: Severe
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.68%
6/881 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.46%
4/862 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
New generalized muscle pain: Mild
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
14.5%
130/894 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
6.7%
58/865 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
New generalized muscle pain: Moderate
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
5.9%
52/886 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
2.8%
24/863 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
New generalized muscle pain: Severe
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.68%
6/882 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.47%
4/860 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Aggravated generalized muscle pain: Mild
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
4.6%
41/886 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
1.9%
16/862 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Aggravated generalized muscle pain: Moderate
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
5.1%
45/885 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
2.8%
24/863 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Aggravated generalized muscle pain: Severe
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.68%
6/882 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.12%
1/860 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
New generalized joint pain: Mild
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
5.0%
44/884 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
3.9%
34/862 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
New generalized joint pain: Moderate
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
2.9%
26/883 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
2.2%
19/864 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
New generalized joint pain: Severe
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.34%
3/882 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.35%
3/860 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Aggravated generalized joint pain: Mild
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
2.3%
20/883 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
1.7%
15/861 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Aggravated generalized joint pain: Moderate
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
3.2%
28/884 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
2.6%
22/862 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
|
General disorders
Aggravated generalized joint pain: Severe
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
—
0/0 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.34%
3/882 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
0.35%
3/860 • Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER